Span Biotech Ltd.

General Information
One-Step Tetracycline Rapid Test is a competitive immunoassay for the semi-quantitative detection of the presence of Tetracycline residue in Milk,Honey,Tissue extract and Aquatic products.
Detection limit: Milk 100 ppb ,Honey 20ppb , Tissue extract 100 ppb , Aquatic products 100ppb
Specimen: Defatted milk, Honey, Tissue extract, Aquatic products
Reading Time : 5-10min

General Information
The Urinalysis Reagent Strips (Urine) are firm plastic strips onto which several separate reagent areas are affixed. The test is for the detection of one or more of the following analytes in urine: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite , Leukocytes and so on.

General Information
Method: Double Antigens Sandwich Method
Sensitivity : 99.5%
Specificity : 98.8%
Specimen : Serum / Plasma
Reading Time : 5- 10 min

General Information
One-Step Nitrofurans Rapid Test are competitive immunoassay for the semi-quantitative detection of the presence of AOZ,AMOZ, AHD, SEM residue in animal tissue.
Detection limit:AOZ 1ppb , AMOZ 1ppb , AHD 1ppb , SEM 1ppb
Specimen: Animal tissue
Reading Time :10-15 min

INTENDED USE

The HCG s/u Gold Rapid Screen Test(RST)is a chromatographic immunoassay for the early detection of human chronic gonadotropin (HCG) in serum/plasma or urine specimens.

INTRODUCTION

HCG is a glycoprotein hormone secreted by the developing placenta during pregnancy. The concentration of HCG in serum is approximately equal to the concentration in urine. The concentrations of HCG in urine and serum continue to rise during the first trimester of pregnancy to as high as 100,000 mIU/ml. HCG appears in urine shortly after conception, and continues to increase during the early stages of pregnancy, making it an excellent indicator for the detection of pregnancy.

PRINCIPLE

The membrane of the test device was coated with anti HCG antibodies on the test region and goat anti mouse IgG antibodies on the control region. During the test, urine specimen is allowed to react with the HCG monoclonal antibody-colloid gold conjugate, which was pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by capillary action. For a positive specimen, the conjugate binds to the HCG forming an antibody-antigen complex. This complex is captured by anti HCG antibody immobilized on the test region (T) and produces a pink color band when HCG concentration is equal to or greater than 25mIU/ml. Absence of this colored band in the test region suggests a negative result. To serve as a procedural control, a colored band at the control region(C) will always appear regardless the presence or absence of HCG.

STORAGE

Uncut Sheet Toxoplasma Gondii IgG/IgM Tri-Lines Rapid Test

Specimen :Whold Blood/Serum/Plasma

INTENDED USE

The One Step TOXO IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Toxoplasma gondii in Whole Blood /Serum / Plasma to aid in the diagnosis of TOXO infection. Toxoplasma gondii is an obligate intracellular protozoan parasite with a worldwide distribution. Serological data indicates that approximately 30% of the population of most industrialized nations is chronically infected with the organism. A variety of serologic tests for antibodies to Toxoplasma gondii have been used as an aid in diagnosis of acute infection and to assess previous exposure to the organism. These tests are the Sabin-Feldman dye test, direct agglutination, indirect hemagglutination, latex agglutination, indirect immunofluorescence, and ELISA. Recently, lateral flow chromatographic immunoassay, such as The Toxo IgM/IgG Rapid Test (Whole Blood/Serum/Plasma) was introduced into the clinic for the serodiagnosis of Toxoplasma gondii infection. One step TOXO IgG/IgM Test is a simple, visual qualitative test that detects TOXO antibodies in human Whole Blood/serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes.

Storage and Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

One Step Troponin Test (Whole blood/Serum/Plasma
FOR IN VITRO DIAGNOSTIC USE ONLY
SPECIMEN COLLECTION
1. Testing should be performed immediately after the specimens have been collected. Do not leave the specimens at room temperature for prolonged periods. Specimens may be stored at 2-8C for up to 3 days. For long-term storage, specimens should be kept below -20C.
2. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
MATERIALS PROVIDED
1. Test cards individually foil pouched with a desiccant
2. Plastic dropper
3. Package insert
MATERIALS REQUIRED BUT NOT PROVIDED
1. Timer/clock
2. Pipette
3. Controls

ASSAY PROCEDURE
1. Read package insert carefully before testing. Allow the test devices, whole blood, serum or plasma to equilibrate to room temperature (15-30C) prior to testing. Do not open pouches until ready to perform the assay.
2. Remove the test device from the foil pouch and use it as soon as possible.
3. Place the test device on a clean and level surface. Hold the dropper provided vertically and transfer 3 drops of specimen (100�µl) to the specimen well (S) in the test device.
4. Wait for the red line(s) to appear. The result should be read between 10 to 15 minutes.
INTERPRETATION OF RESULTS
1. Positive Two colored lines should be observed in the viewing window. The line in the test region (T) is the probe line; the line in the control region (C) is the control line, which is used to indicate proper performance of the device. The color intensity of the test line may be weaker or stronger than that of the control line.
2. Negative The control line appears in the test window, but the test line is not visible.
3. Invalid No line appears in the control region. Under no circumstances should a positive sample be identified until the control line forms in the viewing area. If the control line does not form, the test result is inconclusive and the assay should be repeated.

1. The One Step RV IgG/IgM Test can be performed used on Whole Blood /Serum / Plasma.
2. To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures.
3. Testing should be performed immediately after specimen collection. Do not leave the specimens at room temperature for prolonged periods. For long term storage, specimens should be kept below -20â??. Whole blood should be stored at 2-8â?? if the test is to be run within 2 days of collection. Do not freeze whole blood specimens.
4. Bring specimens to room temperature prior to testing. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly.
Test Procedure
Allow the test, specimen, buffer and/or controls to reach room temperature 15-30â?? (59-86â??) prior to testing.
1. Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
2. Place the test device on a clean and level surface.
3. Hold the dropper vertically and transfer 1 drop of specimen (approximately 10μl) to the specimen well(S) of the test device, then add 2 drops of buffer (approximately 80μl) and start the timer. See illustration below.
4. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
Interpretation of Results
Positive: Control line and at least one test line appear on the membrane. The appearance of T2 test line indicates the presence of RV specific IgG antibodies. The appearance of T1 test line indicates the presence of RV specific IgM antibodies. And if both T1 and T2 line appear, it indicates that the presence of both RV specific IgG and IgM antibodies. The lower the antibody concentration is, the weaker the result line is.
Negative: One colored line appears in the control region(C). No apparent colored line appear in the test line region.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

The Herpes Simplex Virus Rapid Test is a rapid qualitative lateral flow test designed for the quantitive detection of IgG antibodies to Herpes Simplex Virus (HSV) in human serum/plasma samples.

HSV-1 is usually associated with infection in oropharyngeal area and eyes, while HSV-2 causes mostly genital and neonatal infections (5, 6), however, the tissue specificity is not absolute (7). HSV-2 can be isolated occasionally from the oropharynx and 5-10% of primary genital infections may be caused by HSV-1. Infants infected with HSV appear normal at birth, but almost invariably develop symptoms during the newborn period (5, 8, 9). Neonatal HSV infection may remain localized or become disseminated. Localized infection may involve one or a combination of sites. These are skin, eyes, mouth or the central nervous system. Disseminated infection is manifested by pneumonitis, hepatitis, disseminated intravascular coagulopathy and encephalitis. Of the infants with neonatal HSV, about one half of those surviving will develop severe neurological or ocular sequelae. A number of serological procedures have been developed to detect antibodies to HSV. These include complement fixation, indirect immunofluorescent antibody, plaque neutralization, and ELISA (6, 8, 10). Antibody of the IgG class is produced during the first 2-3 weeks of infection with HSV and exists only transiently in most patients. Serologic procedures, which measure the presence of IgG antibodies, help discriminate between primary and recurrent infections, since IgG antibodies is rarely found in recurrent infections. High affinity IgG antibodies to HSV, if present in a sample, may interfere with the detection of IgG specific antibody (9). High affinity IgG antibody may preferentially bind to HSV-1 antigen leading to false negative IgG results. Also, rheumatoid factor, if present, along with antigen specific IgG, may bind to IgG causing false positive IgG results. Both problems can be eliminated by deactivating IgG in the sample before testing for IgG.

General information

One-step influenza a/b test is detection influenza type a and type b nucleoprotein antigen extracted from the nasal swab specimen.
Sensitivity : 91.3% , specificity : 95.7%
Detection limit:5.1x105tcid50/ml
Specimen: nasal swab
Reading time : 15-20min

General Information
One-Step Ractopamine Rapid Test does not require any equipment for the detection of pig urine,Tissue and Feed Ractopamine residues.
Detection limit: 3ppb
Specimen: Urine, Tissue ,Feed
Reading Time :3-5 min

INTENDED USE

The Malaria Rapid Test is a lateral flow chromatographic

immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen and P. vivax, P. ovale, or P. Malariea antigen in whole blood. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with Plasmodium. Any reactive specimen with the Malaria Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

SUMMARY AND EXPLANATION OF THE TEST

Malaria is a mosquito-borne, hemolytic, febrile illness that infects over 200 million people and kills more than 1 million people per year. It is caused by four species of Plasmodium: P. falciparum, P. vivax, P.ovale, and P. malariae. These plasmodia all infect and destroy human erythrocytes, producing chills, fever, anemia, and splenomegaly. P. falciparum causes more sever disease than the other plasmodial species and accounts for most malaria deaths. P. falciparum and P. vivax are the most common pathogens, however, there is considerable geographic variation in species distribution1. Traditionally, malaria is diagnosed by the demonstration of the organisms on Giemsa stained smears of peripheral blood, and the different species of plasmodium are distinguished by their appearance in infected erythrocytes1. The technique is capable of accurate and reliable diagnosis, but only when performed by skilled microscopists using defined protocols2, which presents major obstacles for the remote and poor areas of the world.

The Malaria Rapid Test is developed for solving these above obstacles. It detects the antibodies generated in serum or plasma in response to the infection of plasmodium. Utilizing the Pf. specific antigen (HRP-II) and pan-malaria antigen (aldolase), the test enables simultaneous detection and differentiation of the infection of P.falciparum and or P. vivax, ovale, and malariae3-5, by untrained or minimally skilled personnel, without laboratory equipment.

General Information
One-Step Chlamydia Rapid Test (Swab/Urine) is detection of Chlamydia trachomatis in female cervical swab, male urethral swab and male urine specimens to aid in the diagnosis of Chlamydia infection.
Detection limit:1*103IFU/ml
Specimen: Swab/Urine
Reading Time : 10min

General Information
One-Step Beta-Lactam Rapid Test is a competitive immunoassay for the semi-quantitative detection of the presence of Beta-Lactam residue in milk.
Specimen: Milk
Reading Time : 5-10min

INTENDED USE



Giardia Ag Feces Rapid Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of Giardia antigen in feces.



Assay Time: 5-10 min

Sample: Feces



PRINCIPLE



Giardia Ag Feces Rapid Test is based on sandwich lateral flow immunochromatographic assay. The test device has a testing window. The testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough Giardia antigen in the sample, a visible T band will appear. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of Giardia antigen in the sample..

INTENDED USE

The Malaria Rapid Test is a lateral flow chromatographic

immunoassay for the simultaneous detection and differentiation of Plasmodium falciparum (Pf) antigen in whole blood. This device is intended to be used as a screening test and as an aid in the diagnosis of infection with Plasmodium. Any reactive specimen with the Malaria Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

STORAGE

Store the test kits at room temperature 4- 30 degrees C. The sealed pouch has a self life of 24 months.of transmitting disease.

INTENDED USE
The Malaria Gold Rapid Test is a lateral flow chromatographic
immunoassay for the simultaneous detection and differentiation of
antibodies including IgG, IgM and IgA to Plasmodium falciparum (Pf)
and vivax, ovale, and malariea (Pv.o.m) in whole blood. This device is
intended to be used as a screening test and as an aid in the diagnosis of
infection with Plasmodium. Any reactive specimen with the Malaria
Gold Rapid Test must be confirmed with alternative testing method(s)
and clinical findings.

REAGENTS AND MATERIALS PROVIDED
1. Each kit contains 25 test devices, each sealed in a foil pouch with
three items inside:
a. One cassette device.
b. One plastic dropper.
c. One desiccant.
2. Sample diluent (1 vial, 5 ml)
3. One package insert (instruction for use).

MATERIALS REQUIRED BUT NOT PROVIDED
1. Clock or Timer
2. Lancing device for whole blood test

One Step Fecal Occult Blood (FOB) Rapid Test Cassette (Feces)
Cat. No.: RH0301T
INTENDED USE
The One-Step Fecal Occult Blood (FOB) Diagnostic Kit is a qualitative detection of human occult blood in feces forself-testing.
PRINCIPLE
The One-Step Fecal Occult Blood (FOB) Diagnostic Kit is an immunochromatographic sandwich method, which employ two specific monoclonal antibodies to selectively identify hemoglobin in test samples. The result is very specific, and easier to interpret than those of guaiac-based test. The sensitivity is very high with the ability to detect 200ng/ml hemoglobin in feces. In addition, the accuracy of the test is not affected by interfering substances, and dietary restriction is not necessary.
STORAGE
The kits should be stored at temperature 4-30�°C, the sealed pouch for the duration of the shelf life (24 months). Do the test in 1 hour after open the pouch.
WARNING AND PRECAUTIONS
1. For in vitro diagnostic use only.
2. Do not use kit beyond the expiration date.
3. Patient specimens may contain infectious agents and should be handled as though capable of transmitting disease. Wear disposable gloves throughout the specimen collection and assay procedures.
4. The test device should not be reused.
REAGENTS AND MATERIALS PROVIDED
1. One pouched cassette with desiccant.
2. One operating Instruction
MATERIALS REQUIRED BUT NOT PROVIDED
1. Clock or Timer
SPECIMEN COLLECTION AND PREPARATION
1. Collect stool sample by using the sample collection device provided.
2. Unscrew the top of the sample collection device, take out the sample collection stick, and collect the sample by dipping the stick into 3 different places of the stool sample.
3. Put the sample collection stick back in the sample collection device and screw together tightly.
4. If the sample cannot be tested on the day of collection, store the stool sample at 4C. Bring the specimen to room temperature before testing.
ASSAY PROCEDURE
1. Remove the test device from foil pouch by tearing along the notch.
2. Specimen collection. Please see also SAMPLE COLLECTION AND PREPARATION
3. Shake the sample collection device several times.
4. Holding the sample collection device upright, carefully unscrew the tip of collection device.
5. Squeeze 2-3 drops of the sample solution on the test sample pad.
6. Read the test results in 5 minutes.
INTERPRETATION OF RESULTS
Negative: Only one colored band appears on the control region (C). No colored band in the test region (T).
Positive: In addition to the control band (C), a distinct colored band also appears in the test region (T).
Invalid: If no bands appear, or a test band appears without a control band, the test should be repeated using a new test device.

Antibiotics Residue In Milk Rapid Test(Quinolone Rapid Test)



INTENDED USE

Quinolone Test is a competitive immunoassay for the semi-quantitative detection of the presence of Quinolone in milk.

Cut-off: 50 ppb

Assay Time: 10 - 15 min

Sample: milk

PRINCIPLE OF THE ASSAY

Quinolone Test is based on competitive lateral flow immunochromatographic assay. The Quinolone conjugate in the test zone will capture the immuno-gold, when there is very little dissociative Quinolone in the sample. A visible red test band indicates a negative result when the control line shows that the card is valid. The test band will be not visible if Quinolone is present in concentration of 50 ppb and above which explains a positive result.

Intended use

The one step anti-dengue (igm & igg) tri-line test is a colloidal gold enhanced, rapid immunochromatographic assay for the qualitative detection of antibodies (igm & igg) to dengue virus (dv) in human whole blood, serum or plasma. This test is a screening test, and all positives must be confirmed using an alternate test such as western blot. The test is intended for healthcare professional use only.

Intended use

The one step dengue ns1 ag test is a rapid chromatographic immunoassay for the qualitative detection of dengue virus ns1 antigen in serum or plasma to aid in the diagnosis of dengue viral infection.

Summary

Dengue is transmitted by the bite of an aedes mosquito infected with any one of the four dengue viruses. It occurs in tropical and sub-tropical areas of the world. Symptoms appear 3-14 days after the infective bite. Dengue fever is a febrile illness that affects infants, young children and adults. Dengue haemorrhagic fever (fever, abdominal pain, vomiting, bleeding) is a potentially lethal complication, affecting mainly children. Early clinical diagnosis and careful clinical management by experienced physicians and nurses increase survival of patients. One step dengue ns1 ag test is a simple, visual qualitative test that detects dengue virus ns1 antigen in human serum or plasma. The test is based on immunochromatography and can give a result within 15 minutes.

Intended use

Giardia ag feces rapid test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of giardia antigen in feces.
Assay time: 5-10 min
Sample: feces

The One Step TORCH IgG/IgM Test is a panel of rapid qualitative lateral flow test designed for the quantitive detection of IgG and IgM antibodies to Toxoplasma gondii (TOXO), Cytomegalovirus (CMV), Rubella, Herpes Simplex Virus (HSV) in human serum/plasma samples.

Home Menopause Test Strip is an in vitro diagnostic (IVD) qualitative test for rapid detection of human Follicle Stimulating Hormone (FSH) in urine at a sensitivity of 25mIU/ml.

SUMMARY AND EXPLANATION OF THE TEST

Follicle Stimulating Hormone (FSH) is a peptide hormone produced in the pituitary gland of the brain. It is normally present in the blood or urine varying in concentration with the stage of the menstrual cycle. When estrogen levels drop, FSH is released from the pituitary gland indicating that either a woman in mid-menstrual cycle or the onset of perimenopause. During early menopause, changes take place in the balance of hormones that regulate and control menstrual cycles. As a woman grows older and passes out of childbearing stage of life, the ovaries gradually make less of the hormone estrogen and FSH increases.FSH normally regulates the growth and development of an egg. Once this part of the monthly cycle is complete, FSH production is stopped and it returns to normal. As the body decreases estrogen production with age, more FSH is made. Over time these hormone changes cause menstrual periods to stop completely and "menopause" has occurred. The slow change in ovary function can happen between 2 and 10 years before the final period. This early stage before menopause is called perimenopause. During this stage, the levels of FSH may rise to positive levels and slowly return to normal, causing irregular or missed periods. The testing for FSH should be performed twice to help identify the levels of FSH throughout a menstrual cycle.

PRECAUTION

1. For in vitro diagnostic use only.

2. Do not use after expiration date.

3. Test device should remain sealed until ready for use. Do not use if pouch is damaged or opened.

4. Read this instruction carefully before performing the test.

5. Do not re-use the test device.

6. Do not eat the desiccant in the pouch.

General Information

The Urinalysis Reagent Strips (Urine) are firm plastic strips onto which several separate reagent areas are affixed. The test is for the detection of one or more of the following analytes in urine: Ascorbic acid, Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite , Leukocytes and so on.

General information

One-step tumor marker rapid test is an immunochromatography based one-step in vitro diagnostics test for the qualitative determination of afp, psa and cea in human serum or plasma.
Afp : alpha-feto protein test to detect liver cancer
Psa : prostate-specific antigen test to detect prostate cancer
Cea : carcinoembryonic antigen test to detect colorectal cancer
Specimen : serum or plasma
Reading time : 20 min

General information

One-step cow pregnancy rapid test is to improve milk output and shortening the period of non-pregnancy.
Analytical sensitivity : 2ng/ml
Sensitivity : 96.9% , specificity : 97.8%
Specimen : milk
Reading time : 5 min
No cross-reactivity: fsh (100g/ml), e2(10g/ml), prl(100g/ml), lh(25miu/ml), dht(10g/ml), tetraborane(10g/ml) and h2o.

INTENDED USE

The One Step RV IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Rubella (Virus) in Whole Blood /Serum / Plasma to aid in the diagnosis of RV infection. The test is based on immunochromatography and can give a result within 15 minutes.

PRINCIPLE

The One Step RV IgG/IgM Test is a qualitative membrane strip based immunoassay for the detection of RV antibodies (IgG and IgM) in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing RV recombinant envelope antigens conjugated with Colloid gold (RV conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgM anti-RV, T2 band is coated with antibody for the detection of IgG anti-RV, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-RV, if present in the specimen, will bind to the RV conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a RV IgG positive test result and suggesting a recent or repeat infection. IgM anti-RV if present in the specimen will bind to the RV conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a RV IgM positive test result and suggesting a fresh infection. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

Storage and Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

Specimen:Whole Blood /Serum / Plasma

D-Dimer Rapid Test Device is used for the qualitative detection of D-dimer in human whole blood and plasma; The test is used as an aid in the assessment and evaluation of patients with suspected disseminated intravascular coagulation (DIC), deep vein thrombosis (DVT), and pulmonary embolism (PE).

During blood coagulation process, fibrinogen is converted to fibrin by the activation of thrombin. The resulting fibrin monomers polymerise to form a soluble gel of non-cross-linked fibrin. This fibrin gel is then converted to cross-linked fibrin by thrombin activated Factor XIII to form an insoluble fibrin clot. Production of plasmin, the major clot-lysing enzyme, is triggered when a fibrin clot is formed. Although fibrinogen and fibrin are both cleaved by the fibrinolytic enzyme plasmin to yield degradation products, only degradation products from cross-linked fibrin contain D-dimer and are called cross-linked fibrin degradation products. Therefore, fibrin derivatives in human blood or plasma containing D-dimer are a specific marker of fibrinolysis.

The D-Dimer Rapid Test Device (Whole blood//Plasma) detects D-Dimer through visual interpretation of color development in the internal strip. Anti-D-Dimer antibodies are immobilized on the test region of the membrane, and anti-mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti-D-Dimer antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient D-Dimer in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

1. INTENDED USE

CPV + CCV Ag Combined Test is a combined cassette to differentially diagnose the presence of Canine Parvovirus antigen and Canine Coronavirus antigen in dogâ??s feces or vomit.

Assay Time: 5 -10 min

Sample: Feces or vomit

2. PRINCIPLE OF THE ASSAY

CPV + CCV Ag Combined Test is based on sandwich lateral flow immunochromatographic assay. The test device has two testing windows. Each testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough CPV antigen or CCV antigen in the sample, a visible T band will appear in the corresponding testing window. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of CPV antigen or CCV antigen in the sample.

3. KIT COMPONENT

- 10Ã?foil pouches, each containing acassette, pipette and desiccant

- 10Ã?assay buffer tubes (1.0 mL each)

- 10Ã?swab sticks

- Product Manual

1. INTENDED USE

CDV + CPV Ag Combined Rapid Test is a combined cassette to diagnose the presence of Canine Disteimper virus antigen and Canine Parvovirus antigen in dogâ??s secretions, serum or feces.

Assay Time: 5 - 10 min

Sample: Secretions, serum or feces

2. PRINCIPLE OF THE ASSAY

CDV + CPV Ag Combined Rapid Test is based on sandwich lateral flow immunochromatographic assay. The test device has two testing windows. Each testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough CDV antigen or CPV antigen in the sample, a visible T band will appear in the corresponding testing window. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of CDV antigen or CPV antigen in the sample.

3. KIT COMPONENT

- 10Ã?foil pouches each containing a cassette, pipette and desiccant

- 10Ã?assay buffer tubes (0.7 mL each)

- 10Ã?assay buffer tubes (1.0 mL each)

- 20Ã?swab sticks

- Product Manual

INTENDED USE

The HCV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to

Hepatitis C type virus (HCV) in human serum/ plasma and whole blood.

PRINCIPLE

HCV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HCV in human serum/plasma and whole blood. HCV recombinant antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HCV recombinant antigens. If antibodies to HCV present, a pink colored band will develop on the membrane in proportion to the amount of HCV antibodies present in the specimen .Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a purple colored band in the control region will always appear regardless the presence of antibodies to HCV.

REAGENTS AND MATERIALS PROVIDED

1. One pouched cassette with desiccant.

2. Blood diluent in a dropper bottle, stored at 4-30°C.

3. One piece of operating instruction.

WARNING AND PRECAUTIONS

1. For in vitro diagnostic uses only.

2. All patient samples should be treated as if capable of transmitting diseases.

3. Do not interchange reagents from different lots or use test kit beyond expiration date.

4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).

INTENDED USE

The HCV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to

Hepatitis C type virus (HCV) in human serum/ plasma and whole blood.

PRINCIPLE

HCV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HCV in human serum/plasma and whole blood. HCV recombinant antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HCV recombinant antigens. If antibodies to HCV present, a pink colored band will develop on the membrane in proportion to the amount of HCV antibodies present in the specimen .Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a purple colored band in the control region will always appear regardless the presence of antibodies to HCV.

REAGENTS AND MATERIALS PROVIDED

1. One pouched cassette with desiccant.

2. Blood diluent in a dropper bottle, stored at 4-30°C.

3. One piece of operating instruction.

WARNING AND PRECAUTIONS

1. For in vitro diagnostic uses only.

2. All patient samples should be treated as if capable of transmitting diseases.

3. Do not interchange reagents from different lots or use test kit beyond expiration date.

4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).

INTENDED USE

The HCV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to

Hepatitis C type virus (HCV) in human serum/ plasma and whole blood.

PRINCIPLE

HCV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HCV in human serum/plasma and whole blood. HCV recombinant antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HCV recombinant antigens. If antibodies to HCV present, a pink colored band will develop on the membrane in proportion to the amount of HCV antibodies present in the specimen .Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a purple colored band in the control region will always appear regardless the presence of antibodies to HCV.

REAGENTS AND MATERIALS PROVIDED

1. One pouched cassette with desiccant.

2. Blood diluent in a dropper bottle, stored at 4-30°C.

3. One piece of operating instruction.

WARNING AND PRECAUTIONS

1. For in vitro diagnostic uses only.

2. All patient samples should be treated as if capable of transmitting diseases.

3. Do not interchange reagents from different lots or use test kit beyond expiration date.

4. Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

STORAGE

The kits should be stored at temperature 4-30°C, the sealed pouch for the duration of the shelf life (24 months).

Uncut Sheet HBsAb Rapid Test

Package:30sheets/pouch

Specimen:Whole Blood/Serum/Plasma

FOR THE QUALITATIVE ASSESSMENT OF HBsAb IN HUMANSERUM, PLASMA OR WHOLE BLOOD

INTENDED USE

Rapid HBsAb Test is a chromatographic immunoassay for qualitative detection of the surface antibody of hepatitis B virus (Anti-HBs) in human whole blood samples. It is intended for use in medical institution as an aid for diagnosis and management of patients related to infection with hepatitis B as well for screening of blood donors or blood products

PRINCIPLE

Rapid HBsAb Test employs chromatographic lateral flow device. Colloidal gold conjugated surface antigen reactive to anti-HBs (sAg-Au) are dry-immobilized onto a nitrocellulose membrane strip. When the sample is added, it migrates by capillary diffusion through the strip rehydrating the gold conjugate. If present, anti-HBs will bind with the gold conjugated antigens forming particles. These particles will continue to migrate along the strip until the Test Zone (T) where they are captured by HBsAg immobilized there and a visible red line appears. If there is no anti-HBs in sample, no red line will appear in the Test Zone (T). The gold conjugate will continue to migrate alone until is captured in the Control Zone (C) from immobilized goat, anti-HBs antibody and aggregating in a red line, which indicates the validity of the test

STORAGE

Store the test device at 4 to 30°C. Do Not Freeze.

Uncut Sheet HBsAg Rapid Test

Package:30sheets/pouch

Specimen:Whole blood/Serum/Plasma

FOR THE QUALITATIVE ASSESSMENT OF HBsAg IN HUMAN SERUM, PLASMA OR WHOLE BLOOD

INTENDED USE

The HBsAg Rapid Test is a Chromatographic immunoassay (CIA) for direct qualitative detection of Hepatitis B type virus surface antigen (HBsAg) in human serum /plasma and whole blood.

PRINCIPLE

The HBsAg RST is a chromatographic immunoassay (CIA) for the detection of surface antigens of Hepatitis B in human serum/plasma and whole blood. Specific antibody against HBsAg is pre-coated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with anotherr specific antibody. If HBsAg is present, a pink colored band will develop on the membrane in proportion to the amount of HBsAg presented in the specimen. Absence of this pink colored band in the test region suggests a negative result. To serve as a procedural control, a pink colored band in the control region will always appear regardless the presence or absence of HBsAg.

REAGENTS AND MATERIALS PROVIDED

1.One sealed pouched cassette with desiccant and a disposable pipette..

2.Blood diluent in a dropper bottle. Store at 2-8°C.

3.One piece of operating instruction with 40 test pouches..

Uncut Sheet Leishmania IgG/IgM Rapid Test

Specimen:Whole Blood/ Serum/ Plasma

INTENDED USE

The Leishmania IgG/IgM Rapid Test is a lateral flow immunoassay for the qualitative detection of antibodies including IgG and IgM to the subspecies of the Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans in human serum or plasma. This test is intended to be used as a screening test and as an aid in the diagnosis of the disease of Visceral leishmaniasis. Any reactive specimen with the Leishmania IgG/IgM Rapid Test must be confirmed with alternative testing method(s).

SUMMARY AND EXPLANATION OF THE TEST

Visceral leishmaniasis, or Kala-azar, is a disseminated infection caused by several subspecies of the L. donovani. The disease is estimated by the World Health Organization (WHO) to affect approximately 12 million people in 88 countries1. It is transmitted to humans by bites of the Phlebotomus sandflies, which acquire infection from feeding on infected animals. Though it is a disease for poor countries, in Southern Europe, it has become the leading opportunistic infection in AIDS patients2-3.

Identification of L. donovani organism from the blood, bone marrow, liver, lymph nodes or the spleen provides a definite means of diagnosis. However, these test methods are limited by the sampling method and the special instrument requirement. Serological detection of anti-L. donovani Ab is found to be an excellent marker for the infection of Visceral leishmaniasis. Tests used in clinic include: ELISA, fluorescent antibody and direct agglutination tests4-5. Recently, utilization of L. donovani specific protein in the test has improved the sensitivity and specificity dramatically6-7.

The Leishmania IgG/IgM Rapid Test is a recombinant protein based serological test, which detects antibodies including IgG, IgM and IgA to the L. Donovani. This test provides a reliable result within 10 minutes without any instrumentation requirements.

AMP INTENDED USE

The AMP Gold Rapid Screen Test is a qualitative competitive binding immunoassay for determination of Amphetamine in urine.

AMP PRINCIPLE

The Amp Gold Rapid Screen Test is a chromatographic absorbent device in which drug or drug metabolites in a sample compete with drug antigen immobilized on a porous membrane support for limited antibody sites. Labeled antibody-dye conjugate mixes with sample specimen and binds to the free drug presented in sample forming an antibody-antigen complex. This complex prevents the formation of pink color bands in the test zone immobilized antigen conjugate when the drug is presented in the sample urine above the detection levels (1000ng/ml for Amphetamine). Unbound dye conjugate binds to the reagent in the control zone and produces a pink-rose color band, demonstrating that the reagents and device are functioning correctly.

A negative specimen produces two distinct color bands, one for the control in the �¢??C�¢?? zone and one for Amphetamine in the �¢??T�¢?? zone.

AMP REAGENTS AND MATERIALS PROVIDED

1. Test Device A pouched cassette contains a single test for Amphetamine

2. Dropper A transfer pipette seal in foil pouch together with test device

3. Operating Instructio MATERIALS REQUIRED BUT NOT PROVIDED

AMP MATERIALS REQUIRED BUT NOT PROVIDED
Packaging Details:
Pouch+Box+Carton packaging

(1) With our companyâ??s Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Anna Lee

Int'l Market Executive

General information
One-step pregnancy test is a rapid qualitative one-step assay for detection of hcg in urine/ or serum/ plasma.
Analytical sensitivity : 25miu/ml , 10miu/ml
Sensitivity : 100% , specificity : 100%
Specimen : urine or serum/ plasma
Reading time : 3 min
No cross-reactivity : hlh (300 miu/ml), hfsh (1,000 miu/ml), and htsh (1,000 ml)

General information
The malaria rapid test is detection and differentiation of plasmodium falciparum (pf) antigen and p. Vivax, p. Ovale, or p. Malariea antigen in whole blood.
Detection limit:pf 50parasites/ul , pv 75 parasites/ul
Specimen : whole blood
Reading time : 10 min

General Information

One-Step Troponin I /CK-MB/ Myoglobin Rapid Test is intended for the qualitative determination of cardiac disease in human serum, plasma or whole blood.

General information

Method: double antibodies sandwich method
Sensitivity : 100%
Specificity : 99.8%
Specimen : ocular and nasal secretions, serum, plasma
Detection limit: 101.9 tcid50 / 0.1 ml
No cross reaction against cpv, ccv, civ, cpiv
Reading time : 5- 10 min

General information

Feline infectious peritonitis virus ag test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of fip-triggerred coronavirus antigen(fcov ag) in cat’s feces, serum and ascites.
Assay time: 10 - 15 min
Sample: mixture of serum and feces extraction, ascites or secretions

General information

One-step cdv + cpv ag combined rapid test is a combined cassette to diagnose the presence of canine disteimper virus antigen and canine parvovirus antigen in dog’s secretions, serum or feces.
Sensitivity : cdv 100% cpv 99.3%
Specificity :cdv 99.8% cpv 99.4%
Specimen: secretions, serum or feces
Reading timen:5-10 min

General Information
One-Step TB IgG/IgM Rapid Test is detection antibodies(IgG and IgM) anti-Mycobacterium Tuberculosis(M.TB) in human blood.
Sensitivity :86.7% , Specificity : 90%
Specimen : Serum, Plasma or Whole Blood
Reading Time : 10 min

One-Step Adenovirus Ag Rapid Test

Formats:Uncut Sheets , Bulk Package, 30Tests/Box ,OEM

Specimen:Feces

INTENDED USE

The Adenovirus Rapid Test Device (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of adenovirus in human fecal specimens. This kit is intended to be used as an aid in the diagnosis of adenovirus infection.

INTRODUCTION

Acute diarrheal disease in young children is a major cause of morbidity worldwide and is a leading cause of mortality in developing countries. Research has shown that enteric adenoviruses, primarily Ad40 and Ad41, are a leading cause of diarrhea in many of these children, second only to the rotaviruses. These viral pathogens have been isolated throughout the world, and can cause diarrhea in children year round. Infections are most frequently seen in children less than two years of age, but have been found in patients of all ages. Further studies indicate that adenoviruses are associated with 4-15% of all hospitalized cases of viral gastroenteritis.

Rapid and accurate diagnosis of gastroenteritis due to adenovirus is helpful in establishing the etiology of gastroenteritis and related patient management. Other diagnostic techniques such as electron microscopy (EM) and nucleic acid hybridization are expensive and labor-intensive. With the self-limiting nature of adenovirus infection, such expensive and labor-intensive tests may not be necessary.

Intended Use

The Influenza A +B Test is a rapid chromatographic immunoassay for the qualitative detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. This kit is intended to be used as an aid in the diagnosis of influenza A and influenza B virus in nasal swab specimens.

Principle

The Influenza A +B Test is a qualitative membrane strip based immunoassay for the detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. In this test procedure, influenza type A antibody is immobilized in the A line, influenza type B antibody is immobilized in the B line. After a specimen is placed in the specimen well, it reacts with influenza type A antibody and/or B antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized antibody. If the specimen contains influenza type A, a colored line will appear in the A line region indicating a influenza type A positive result. If the specimen contains influenza type B, a colored line will appear in the B line region indicating a influenza type B positive result. Absence of any T lines (A and B) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Storage and Stability

1.Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch.

2.The test must remain in the sealed pouch until use.

Uncut Sheet HCG Urine/Serum Rapid Test

SPECIMEN: Whole Blood/ Serum/ Plasma

INTENDED USE

The One Step TOXO IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Toxoplasma gondii in Whole Blood /Serum / Plasma to aid in the diagnosis of TOXO infection. Toxoplasma gondii is an obligate intracellular protozoan parasite with a worldwide distribution. Serological data indicates that approximately 30% of the population of most industrialized nations is chronically infected with the organism. A variety of serologic tests for antibodies to Toxoplasma gondii have been used as an aid in diagnosis of acute infection and to assess previous exposure to the organism. These tests are the Sabin-Feldman dye test, direct agglutination, indirect hemagglutination, latex agglutination, indirect immunofluorescence, and ELISA. Recently, lateral flow chromatographic immunoassay, such as The Toxo IgM/IgG Rapid Test (Whole Blood/Serum/Plasma) was introduced into the clinic for the serodiagnosis of Toxoplasma gondii infection. One step TOXO IgG/IgM Test is a simple, visual qualitative test that detects TOXO antibodies in human Whole Blood/serum/plasma. The test is based on immunochromatography and can give a result within 15 minutes.

Storage and Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (4-30â?? or 40-86â??). The test device is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.

Uncut Sheet H. Pylori (H.P)Ab Rapid Test

Package:30sheets/pouch

Specimen:Whole Blood/Specimen/Serum

INTRODUCTION

One Step H. Pylori Ab wb /serum/plasma test is a rapid test for the qualitative detection of antibodies specific to Helicobacter pylori in human serum/plasma and whole blood. In this test kit, the H. pylori antigen â?? colloid gold conjugate and specimen moves along the membrane chromatographically to the test region and forms a visible line as the antigenantibodyantigen gold particle complex forms with high degree of sensitivity and specificity. This one step test only takes about 1015 minutes. Test results are read visually without any instrumentation.

SPECIMEN COLLECTION & PREPARATION

Both whole blood (with or without anticoagulant), serum and plasma specimens can be used with this assay. Simply follow the standard clinical produres to collect whole blood, serum or plasma specimens. If the specimen cannot be tested on the day of collection, store the serum/plasma specimen in a temperature of 28 ºC for up to 72 hours. Stir and bring the specimens to room temperature before testing. Do not freeze whole blood specimens. Do not freeze and thaw the specimen repeatedly. Attention: Specimens and all materials coming in contact with them should be handling and disposed of as if capable of transmitting infection. Avoid contact with skin by wearing gloves and proper laboratory attire.

REAGENTS AND MATERIALS SUPPLIED

1. Test kit

2. Specimen diluents in dropper bottle

3. Plastic dropper to dispense sample

PRINCIPLE

Progesterone (P4) is a kind of steroid hormone. The concentration change of P4 in milk is one specific characteristic indicating the activities of cow ovary. It plays an important role in the process of maternal reproduction and maintaining pregnancy.

Therefore, it can be monitoring cow reproductive activity by detecting the concentration of P4. P4 concentration has different characteristic changes as the cow's stage of reproductive physiology, through to detect the progesterone levels can make an accurate diagnosis of cow in early pregnancy.

PRODUCT FEATURES

The strip can be used for diagnosis of cow early pregnancy, which is of high accuracy, easy operation, rapid and normal temperature storage, easy to carry, harmless to maternal and fetal safety.

THE SCOPE OF USE

The test is mainly suitable for dairy and beef cattle early pregnancy diagnosis, as well as to guide timely artificial insemination.

THE BEST USE DATE

Cow's estrus cycle is 21 days. There are individual differences in 18 to 24 days commonly, it is suggested to perform the test the 18th days after mating. Perform the test once every day for 5 continuous days; even if one negative result appears during the five days, which indicates the cow is not pregnant and P4 is at the lowest level at this moment. In this case, it was suggested to have the dairy cow mated in time; that should improve the conception rate. If positive results show for all 5 days tests, it indicates the cow is in pregnancy, and it should get careful nursing and gestation management. Another test method is to closely observe the cow rutting performance from 18 days after mating, if it was in rutting performance the detection should do immediately; for those that have no heat after mating to do a test on the 24th day.

SPECIMEN COLLECTION

1.Milk sample: cleaning teats before take the milk, abandon to the first three milk, then collect milk in the bottle, take 1 ml in the test tube, placed the centrifuge10000 rpm for 10 minutes, in vitro milk sample was divided into three layers, using straws inserted in the underlying absorbing liquid cream and set aside.

2.Saliva: from the mouth collecting saliva for 3 to 5 ml placed the centrifuge 1500-2000 rpm for 5 minutes, take supernatant on standby.

3.The galley proof: from the hair root galley proof according to take 10 mg in the extracting pipe, add 3 ml anhydrous ethanol soak vortex shock 5 minutes after 2-3 hours, placed 3000 rpm centrifuge for 5 minutes, drain on ethanol solution 1 ml into glass dish, in 70-80 �?? oven dry reoccupy after 1 ml PBS dilution. Set aside.

4.Urine: can be used directly.

5.Blood: anticoagulant take 1 to 2 ml of centrifugal 2000 rpm 5-10 minutes from the plasma standby, the anticoagulant let stand for 30 minutes to separate serum blood clots. Set aside.

SUMMARY
Bilirubin: This test is based on the coupling of bilirubin with a diazotized dichloroaniline in a strongly acid medium. The colors range from light tan to reddish-brown.
Ketone: This test is based on the reaction of acetoacetic acid with sodium nitroprusside in a strongly basic medium. The colors range from beige or buff-pink color for a Negative reading to pink and pink-purple for a Positive reading.
Specific Gravity: This test is based on the apparent pKa change of certain pretreated polyelectrolytes in relation to the ionic concentration. In the presence of an indicator, the colors range from dark blue or blue-green in urine of low ionic concentration to green and yellow-green in urine of higher ionic concentration.
Blood: This test is based on the pseudoperoxidase action of hemoglobin and erythrocytes which catalyzes the reaction of 3,3, 5, 5-tetramethyl-benzidine and buffered organic peroxide. The resulting colors range from orange to yellow-green and dark green. Very high blood concentration may cause the color development to continue to dark blue.
pH: This test is based on the well known double pH indicator method, where bromothymol blue and methyl red give distinguishable colors over the pH range of 5-9. The colors range from red-orange to yellow and yellow-green to blue-green.
Protein: This test is based on the protein error-of-indicator principle. At a constant pH, the development of any green color is due to the presence of protein. Colors range from yellow for a �??Negative�?? reaction to yellow-green and green to blue-green for a �??Positive�?? reaction.
Urobilinogen: This test is based on a modified Ehrlich reaction in which p-diethylaminobenzaldehyde reacts with urobilinogen in a strongly acid medium. Colors range from light pink to bright magenta.
Nitrite: This test depends on the conversion of nitrate to nitrite by the action of Gram-negative bacteria in the urine. The nitrite reacts with p-arsanilic acid to from a diazonium compound in an acid medium. The diazonium compound in turn couples with 1,2,3,4-tetrahydrobenzo(h) quinolin to produce a pink color.
Leukocytes: This test is based on the action of esterase present in leukocytes, which catalyzes the hydrolysis of an indoxyl ester derivative. The indoxyl ester liberated reacts with a diazonium salt to produce a beige-pink to purple color.
Ascorbic Acid: The composition comprises of a complex chelating agent with a polyvalent metal ion in its higher state and an indicator dye that can reacts with the metal ion in its lower state to produce a color change from blue-green to yellow.

General Information
One-Step neisseria gonorrhoeae antigen test is detection of neisseria gonorrhoeae in female endocervical swab and male urethral swab specimens.
Specimen: Swab/Urine
Reading Time : 10-15 min

General Information
One-Step Beta lactam + Tetracycline Rapid Test is a competitive immunoassay for the semi-quantitative detection of the presence of Beta lactam and Tetracycline residue in milk.
Specimen: Milk
Reading Time : 5-10min

INTENDED USE



The neisseria gonorrhoeae antigen test card is a rapid visual immunoassay for the qualitative detection of neisseria gonorrhoeae in female endocervical swab and male urethral swab specimens. This kit is intended for use as an aid in the diagnosis of neisseria gonorrhoeae infection.



PRINCIPLE



The neisseria gonorrhoeae antigen test kit is designed to detect N. Gonorrhoeae through visual interpretation of the color development in the internal strip. The membrane was immobilized with gonococcal Antigen-specific polychonal antibody on the test region (T) and related antibodies on the control region(C).

During testing, the specimen is added to the sample region (S) and reacts with anti-gonococcus antibodies conjugated to colored particles and precoated onto the sample pad of the test. Then, the mixture migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient gonococcus antigens in the specimen, a colored band will form at the test region (T) of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

The Chagas Ab Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with T. cruzi. Any reactive specimen with the Chagas Ab Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

Chagas disease is an insect-borne, zoonotic infection by the protozoan T. cruzi, which causes a systemic infection of humans with acute manifestations and long term sequelae. It is estimated that 16-18 million individuals are infected worldwide, and roughly 50,000 people die each year from chronic Chagas disease (World Health Organization)1.

Buffy coat examination and xenodiagnosis used to be the most commonly methods2,3 in the diagnosis of acute T. cruzi infection. However, both methods are either time consuming or lack of sensitivity. Recently, serological test becomes the mainstay in the diagnosis of Chagasâ??s disease. In particularly, recombinant antigen based tests eliminate false-positive reactions which are commonly seen in the native antigen tests4-5.

The Chagas Ab Rapid Test is an instant antibody test which detects IgG antibodies the T. cruzi within 15 minutes without any instrument requirements. By utilizing T. cruzi specific recombinant antigen, the test is highly sensitive and specific.

Feline Leukemia Test INTENDED USE
Feline Leukemia Virus AG Rapid Test is a sandwich lateral flow immunochromatographic assay for the
qualitative detection of Feline Leukemia Virus antigen in cat's blood.
Assay Time: 5-10 min
Sample: Serum,Plasma or Whole Blood

Feline Leukemia Test PRINCIPLE
Feline Leukemia Virus AG Rapid Test is based on sandwich lateral flow immunochromatographic assay. The
test device has a testing window. The testing window has an invisible T (test) zone and C (control) zone.
When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the
test strip. If there is enough feline leukemia virus antigen in the sample, a visible T band will appear. The C
band should always appear after a sample is applied, indicating a valid result. By this means, the device can
accurately indicate the presence of feline leukemia virus antigen in the sample.

Feline Leukemia Test KIT COMPONENT
1. Foil pouches, each containing one cassette, one pipette and a desiccant
2. Assay buffer (2.0 mL)
3. Centrifugal tubes
4. Product Manual

Feline Leukemia Test TEST PROCEDURE
1. Take cat's blood, serum or plasma as sample.
2. Take out the cassette from the foil pouch and place it horizontally.
3. Drip 1 drop of sample and immediately drip 2 - 3 drops of assay buffer into the sample hole "S".
4. Interpret the result in 10-15 minutes. Result after 15 minutes is considered as invalid.

1. INTENDED USE

CPV + CCV +Giardia Ag Triple Test is a combined cassette to differentially diagnose the presence of Canine Parvovirus antigen, Canine Coronavirus antigen and Giardia antigen in dogâ??s feces or vomit.

Assay Time: 5-10 min

Sample: Feces or vomit

2. PRINCIPLE OF THE ASSAY

CPV + CCV + Giardia Ag Triple Test is based on sandwich lateral flow immunochromatographic assay. The test device has three testing windows. Each testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough CPV antigen, CCV antigen or Giardia antigen in the sample, a visible T band will appear in the corresponding testing window. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of CPV, CCV or Giardia antigen in the sample.

3. KIT COMPONENT

- 10Ã?foil pouches, each containing onecassette and a desiccant

- 10Ã?assay buffer tubes (1.0 mL each)

- 10Ã?pipettes

- 10Ã?swab sticks

- Product Manual

INTENDED USE

The HCG s/u Gold Rapid Screen Test(RST)is a chromatographic immunoassay for the early detection of human chronic gonadotropin (HCG) in serum/plasma or urine specimens.

INTRODUCTION

HCG is a glycoprotein hormone secreted by the developing placenta during pregnancy. The concentration of HCG in serum is approximately equal to the concentration in urine. The concentrations of HCG in urine and serum continue to rise during the first trimester of pregnancy to as high as 100,000 mIU/ml. HCG appears in urine shortly after conception, and continues to increase during the early stages of pregnancy, making it an excellent indicator for the detection of pregnancy.

PRINCIPLE

The membrane of the test device was coated with anti HCG antibodies on the test region and goat anti mouse IgG antibodies on the control region. During the test, urine specimen is allowed to react with the HCG monoclonal antibody-colloid gold conjugate, which was pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by capillary action. For a positive specimen, the conjugate binds to the HCG forming an antibody-antigen complex. This complex is captured by anti HCG antibody immobilized on the test region (T) and produces a pink color band when HCG concentration is equal to or greater than 25mIU/ml. Absence of this colored band in the test region suggests a negative result. To serve as a procedural control, a colored band at the control region(C) will always appear regardless the presence or absence of HCG.

STORAGE

The kits should be stored at temperature 4-30°C� the sealed pouch for the duration of the shelf life (24months).

Syphilis Test INTRODUCTION

Anti-Syphilis Test is a rapid direct binding test for the visual detection of anti-syphilis antibodies
in serum as an aid in the diagnosis of syphilis infection. Test results are read visually without any
instrument. It is based on the principle of double antigen sandwich immunoassay for determination of syphilis antibodies in serum. Purified recombinant syphilis antigens are employed to identify
anti-Syphilis antibodies specifically. This one step test is very sensitive and only takes about 10 to 20 minutes.

Syphilis Test SPECIMEN COLLECTION

For serum, collect blood into a container without anticoagulant. Allow the blood to clot and separate the serum from the clot. Use the serum for testing. If the specimen cannot be tested on the day of collection, store the serum specimen in a refrigerator or freezer. Bring the specimens to room temperature before testing. Do not freeze and thaw the specimen repeatedly.

Syphilis Test PROCEDURE
Strip
1.When you are ready to begin testing, open the sealed pouch by tearing along the notch. Remove the test from the pouch.
2. Immerse the strip into the container with the arrow end pointing towards the container. Do not immerse past the MAX (maximum) line.
Take the strip out after 8-10 seconds and lay the strip flat on a clean, dry, onabsorbent surface (e.g., mouth of the serum container).
3.Wait 10-15 minutes and read result. Do not read results after 20 minutes.
Cassette
1. Open a pouch containing a cassette, lay the cassette.
2. Using the plastic pipettor provided, draw about 2-3 drops (100mL) the sample into the sample well of the cassette.
3. Read results within 10-15 minutes. Do not read results after 20 minutes.

INTERPRETATION OF RESULTS

Negative: Only one pink band appears on test region of the Cassette. This indicates that there is no detectable Anti-Syphilis in the serum.
Positive: Two pink bands appear on test region of the Cassette. This indicates that the specimen contains detectable amount of Anti-Syphilis.
Invalid: If without colored band appears on test region, this is an indication of a possible error in performing the test. The test should be repeated using a new device.

Syphilis Test PRECAUTION:

1. Must use fresh specimen and avoid repetitive freezing, the result will be invalid
2. Use it before expiry date.
3.The package of kit should not be opened until it reaches the room temperature if it taken out from the refrigerator.
4 .Old Serum can not be used. If the serum is thick, it can be used only after being separated.

Syphilis Test LIMITATIONS

The test is for in-vitro diagnostic use only.

As for Urine Reagent Analysis Strip Uncut Sheets , we have various parameters ranging from 1 to 12 .

We can provide you strip and uncut sheet URS format with high quality and competitive price

PRINCIPLE AND EXPECTED VALUES
URS Ascorbic acid: This test involves decolorization of Tillmann's reagent. The presence of ascorbic acid causes the color of the test field to change from blue-green to orange. Glucose: This test is based on the enzymatic reaction that occurs between glucose oxidase, peroxidase and chromogen. Glucose if first oxidized to produce gluconic acid and hydrogen peroxide in the presence of glucose oxidase. The hydrogen peroxide reacts with potassium iodide chromogen in the presence of peroxidase. The extent to which the chromogen is oxidized determines the color which is produced, ranging from green to brown. Low amounts of glucose are normally excreted in urine.3 Glucose concentrations as low as 100 mg/dL, read at either 10 or 30 seconds, may be considered abnormal if results are consistent. At 10 seconds, results should be interpreted qualitatively. For semi-quantitative results, read at 30 seconds only.


URS Bilirubin: This test is based on azo-coupling reaction of bilirubin with diazotized dichloroaniline in a strongly acidic medium. Varying bilirubin levels will produce a pinkish-tan color proportional to its concentration in urine. In normal urine, no bilirubin is detectable by even the most sensitive methods. Even trace amounts of bilirubin require further investigation. Atypical results (colors different from the negative or positive color blocks shown on the color chart) may indicate that bilirubin-derived bile pigments are present in the urine specimen, and are possibly masking the bilirubin reaction.

INTENDED USE

The test kit utilize purified Chlamydia Trachomatis Antibody antigen, based on GIFA principle and use indirect method to detect Urea Plasma Urealyticum antibody in human serum.


TEST PROCEDURE

1. Remove the test kit and put it at room temperature (for about 20-30mins) before testing.

2. Add 1 drop of Wash Buffer into the hole and allow the liquid soak the membrane completely.

3. Add 150l of the serum specimen into the hole and allow it to sufficient absorption.

4. Add 3 drops of Colloidal Conjugate into the hole and allow it to sufficient absorption.

5. Add 3 drops of Wash Buffer into the hole and allow it to sufficient absorption. Read the results within 3 minutes.

STORAGE
The kit can be stored at room temperature (2-30C). The test kit is stable through the expiration date (18 months) marked on the foil pouch. DO NOT FREEZE. Do not store the test kit in direct sunlight.

Intended Use

The One Step HAV IgG/IgM Test is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Hepatitis A Virus (HAV) in Whole Blood /Serum / Plasma to aid in the diagnosis of Hepatitis A Virus.

Summary

Hepatitis A is an acute, usually self-limiting disease of the liver caused by hepatitis A virus (HAV). HAV is transmitted from person to person, primarily by the faecal-oral route. The incidence of hepatitis A is closely related to socioeconomic development, and seroepidemiological studies show that prevalence of anti-HAV antibodies in the general population varies from 15% to close to 100% in different parts of the world. One step HAV IgG/IgM Test is a simple, visual qualitative test that detects Hepatitis A Virus antibodies in human Whole Blood /Serum / Plasma. The test is based on immunochromatography and can give a result within 15 minutes.

Principle

The One Step HAV IgG/IgM Test is a qualitative membrane strip based immunoassay for the detection of Hepatitis A Virus antibodies (IgG and IgM) in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing HAV recombinant envelope antigens conjugated with Colloid gold (HAV conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing two test bands (T1 and T2 bands) and a control band (C band). The T1 band is pre-coated with the antibody for the detection of IgM anti-HAV, T2 band is coated with antibody for the detection of IgG anti-HAV, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test cassette, the specimen migrates by capillary action across the cassette. IgG anti-HAV, if present in the specimen, will bind to the HAV conjugates. The immunocomplex is then captured by the reagent pre-coated on the T2 band, forming a burgundy colored T2 band, indicating a HAV IgG positive test result and suggesting a recent or repeat infection. IgM anti-HAV if present in the specimen will bind to the HAV conjugates. The immunocomplex is then captured by the reagent coated on the T1 band, forming a burgundy colored T1 band, indicating a HAV IgM positive test result and suggesting a fresh infection. Absence of any T bands (T1 and T2) suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on any of the T bands. Otherwise, the test result is invalid and the specimen must be retested with another device.

Storage and Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (4-30 or 40-86). The test device is stable through the expiration date printed on the sealed pouch.
The test must remain in the sealed pouch until use.

One Step Influenza A Test is a rapid qualitative assay that detects influenza type A (including the subtype H1N1) nucleoprotein antigen extracted from the nasal swab specimen. The device is used to aid in the diagnosis of influenza type A infection.

For in vitro diagnostic use only. For professional use only.

Influenza A SUMMARY

Influenza (commonly known as flu) is a highly contagious, acute viral infection of the respiratory tract. It is a communicable disease that is easily transmitted through the coughing and sneezing of aerosolized droplets containing live virus. Influenza outbreaks occur each year during the autumn and winter months. There are three types of influenza viruses: A, B, and C. Only influenza A viruses are further classified by subtype on the basis of the two main surface glycoproteins hemagglutinin (HA) and neuraminidase (NA). Influenza A subtypes and B viruses are further classified by strains.

Humans can be infected with influenza types A, B, and C viruses. Subtypes of influenza A that are currently circulating among people worldwide include H1N1, H1N2, and H3N2 viruses. Influenza B viruses can cause morbidity and mortality among humans, but in general are associated with less severe epidemics than influenza A viruses. Although influenza type B viruses can cause human epidemics, they have not caused pandemics. Influenza type C viruses cause mild illness in humans and do not cause epidemics or pandemics.

Influenza A PRINCIPLE

One Step Influenza A Test is a rapid immunochromatographic test for the visual detection of influenza type A antigen (nucleoprotein) extracted from the nasal swab specimen. The test adopts double antibody sandwich method.

When the extracted specimen is added into the test device, the specimen is absorbed into the device by capillary action, mixes with antibody-dye conjugate, and flows across the membrane pre-coated with influenza type A monoclonal antibody.

When the influenza type A antigen levels are at or above the target cutoff (the detection limit of the test), type A antigen in the specimen binds to the specific antibody-dye conjugate and are captured by influenza type A monoclonal antibody immobilized in the relative site of test region T of the device. This produces a colored test band in the test region. When the influenza type A antigen levels are zero or below the target cut off, there is not a visible colored band in the test region of the device. This indicates a negative result for influenza type A.

INTENDED USE

Feline Panleucopenia Virus Ag Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of Feline Panleucopenia Virus (FPV Ag) in cat's feces or vomit.

PRINCIPLE OF THE ASSAY

Feline Panleucopenia Virus(FPV) Ag Test is based on sandwich lateral flow immunochromatographic assay. The test device has a testing window. The testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough Panleucopenia Virus antigen in the sample, a visible T band will appear. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of Panleucopenia Virus antigen in the sample.

INTERPRETATION OF RESULTS

Positive: The presence of both C band and T band, no matter T band is clear or vague.

Negative: Only clear C band appears.

Invalid: No colored band appears in C zone, no matter whether T band appears.

STORAGE

The kit can be stored at room temperature (2-30�°C). The test kit is stable through the expiration date (18 months) marked on the foil pouch. DO NOT FREEZE. Do not store the test kit in direct sunlight.

INTENDED USE

Feline Immunodeficiency Virus Ab Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of Feline Immunodeficiency Virus antibody (FIV Ab) in cat's blood.

PRINCIPLE OF THE ASSAY

Feline Immunodeficiency Virus Ab Test is based on sandwich lateral flow immunochromatographic assay. The test device has a testing window. The testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough FIV antibody in the sample, a visible T band will appear. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of FIV antibody in the sample.

INTERPRETATION OF RESULTS

Positive: The presence of both C band and T band, no matter T band is clear or vague.

Negative: Only clear C band appears.

Invalid: No colored band appears in C zone, no matter whether T band appears.

STORAGE

The kit can be stored at room temperature (2-30C). The test kit is stable through the expiration date (18 months) marked on the foil pouch. DO NOT FREEZE. Do not store the test kit in direct sunlight.

1. INTENDED USE

FIV Ab + FeLV Ag Combined Rapid Test is a combined cassette to differentially diagnose the presence of Feline Immunodeficiency antibody and Feline Leukemia Virus antigen in cat's blood.

Assay Time: 10-15 min

Sample: serum, plasma or whole blood

2. PRINCIPLE OF THE ASSAY

FIV Ab + FeLV Ag Combined Rapid Test is based on sandwich lateral flow immunochromatographic assay. The test device has two testing windows. Each testing window has an invisible T (test) zone and C (control) zone. When sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test strip. If there is enough FIV antibody or FeLV antigen in the sample, a visible T band will appear in the corresponding testing window. The C band should always appear after a sample is applied, indicating a valid result. By this means, the device can accurately indicate the presence of FIV antibody or FeLV antigen in the sample.

3. KIT COMPONENT

- 10 foil pouches, each containing a cassette,pipette and desiccant

- 10 assay buffer tubes (0.5 mL each)

- 10 centrifugal tubes

- Product Manual

HBsAg Rapid Test Cassette Uncut Sheet

Specimen :WB/S/P
Size :300*60mm

One-Step HBsAg Rapid Test is to detect the Hepatitis B Virus Surface Antigen in serum, plasma or whole blood.
Analytical sensitivity : 1ng/ml of HBsAg
Sensitivity :100% , Specificity : 100%
Specimen : Serum , Plasma or Whole Blood
Reading Time : 10 min

General Information
One-Step HIV Ab Rapid Test is to detect the antibodies in serum, plasma or whole blood.
Applied highly purified HIV recombinant proteins: gp120 ,gp41 and gp36 antibody, detect HIV type1,type2 with combining or separate test lines at one time.
Sensitivity : 100% , Specificity : 100%
Specimen : Serum , Plasma ,Whole Blood , or Urine
Reading Time : 10 min

General Information
One-Step HBsAb Rapid Test is to detect the Hepatitis B Virus Surface Antibody in serum, plasma or whole blood.
Analytical sensitivity : 10mIU/ml-30mIU/ml of Anti-HBs
Sensitivity : 99.5%, Specificity : 99.8%
Specimen : Serum , Plasma or Whole Blood
Reading Time : 10 min

The Typhoid IgG/IgM Rapid Test is a lateral flow immunoassay for the simultaneous detection and differentiation of anti-Salmonella typhi (S. typhi)G and IgM in human serum or plasma. It is intended to be used as a screening test and as an aid in the diagnosis of infection with S. typhi. Any reactive specimen with the Typhoid IgG/IgM 2.0 Rapid Test must be confirmed with alternative testing method(s).

General Information
One-Step Chagas IgG/IgM Rapid Test is detection of IgG anti-Trypanosoma cruzi (T. cruzi) in human blood.
Sensitivity: 92.9% , Specificity: 100%
Specimen : Serum, Plasma or Whole Blood
Reading Time : 10 min

General Information
One-Step Dengue Rapid Test is to detect the NS1 antigens in serum, plasma or whole blood.
Sensitivity : 99.9% , Specificity : 99.5%
Specimen : Serum , Plasma and Whole Blood
Reading Time : 10 min

General Information
One-Step Dengue Rapid Test is to detect the NS1 antigens and IgG&IgM antibodies in human blood.
Sensitivity : 99.9% Specificity : 99.5 %
Specimen : Serum, Plasma or Whole Blood
Reading Time : 10 min

General Information
One-Step the D-Dimer Rapid Test Device is a chromatographic immunoassay for the qualitative detection of D-Dimer in human blood.
Specimen : Serum, Plasma or Whole Blood
Reading Time : 10 -15min

General Information
One-Step FOB Rapid Test is qualitative test for the detection of human blood hemoglobin in human stool specimens and early diagnosis for Colon Cancer by Fecal Occult Blood screening with double methods, immunology and chemistry
No Cross reactivity :(Bovine, Hemoglobin, Swine hemoglobin, Horse hemoglobin, Bililrubin, Bovine serum albumin, Vitamin C)
Analytical sensitivity : 20ng/ml of FOB (immunology) ,100ng/ml of FOB (chemistry)
Specimen : Stool

General Information
One-Step Cow Ovulation Rapid Test is to detect the Beta-LH in milk.
Analytical sensitivity : 10mIU/ml
Sensitivity : 90% , Specificity : 90%
Specimen : Milk
Reading Time : 5 min
No cross-reactivity: FSH (500ng/mL), Beta-E2(500ng/mL), PRL(500ng/mL), ASA(20µg/mL), DHT(20¼g/mL), tetraborane(20g/mL) and 0.01nol/mL pH 7.3 PBS

INTENDED USE

The Helicobacter-Pylori antigen rapid test kit (stool) is a rapid visual immunoassay for the qualitative detection of helicobacter pylori antigen in human stool specimens. This kit is used as an aid in the diagnosis of H. pylori infection.



INTRODUCTION

Helicobacter pylori (also known as Campylobacter pylori) as a spiral-shaped gram negative bacteria which infects the gastric mucosa. H. pylori to causes several gastro-enteric diseases such as non-ulcerous dyspepsia, gastric and duodenal ulcer, active gastritis and can even increase the risk of stomach adenocarcinoma.

The epidemiologic study shows that more than 50% of the world's population is infected by H. pylori strains. Infection is more prevalent in developing countries. The lowest infection rate is 20%, and the highest infection rate can be 90% in developing countries. H. pylori strains is the major reason to cause chronic gastritis and gastric ulcers, 80%-90% chronic gastritis patients and 95%-100% gastric ulcers patients are infected by H. pylori strains. So the detection and treatment of H. pylori strains infection is very important.

At present several invasive and non-invasive approaches are available to detect this infection state. Invasive methodologies require endoscopy of the gastric mucosa with histologic, cultural and urease investigation, which are expensive and require some time for diagnosis. Alternatively, non-invasive methods are available such as breath tests, which are extremely complicated and not highly selective, and classical ELISA and immunoblot assays. This Kit belongs to non-invasive approach.

Uncut Sheet Strep A IgG/IgM Rapid Test

Format:Cassette/Strip Uncut Sheet

A rapid test for the qualitative detection of Strep A antigen in throat swab specimens.For professional in vitro diagnostic use only.

INTENDED USE

The Strep A Rapid Test Strip (Throat Swab) is a rapid chromatographic immunoassay for the qualitative detection of Strep A antigen from throat swab specimens to aid in the diagnosis of Group A Streptococcal infection.

SUMMARY

Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigen that can cause serious infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis.1 Left untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess.2 Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer.3,4

The Strep A Rapid Test Strip (Throat Swab) is a rapid test to qualitatively detect the presence of Strep A antigen in throat swab specimens, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen.

PRINCIPLE

The Strep A Rapid Test Strip (Throat Swab) is a qualitative, lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. In this test, antibody specific to Strep A carbohydrate antigen is coated on the test line region of the test. After the test strip is immersed into a specimen, the extracted throat swab specimen reacts with an antibody to Strep A that is coated onto particles. This mixture migrates up the membrane to react with the antibody to Strep A on the membrane and generate a colored line in the test line region. The presence of this colored line in the test line region indicates a positive result, while its absence indicates a negative result. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

MOR Test SUMMARY AND EXPLANATION OF THE TEST

The MOR Gold Rapid Screen Test Strip is a fast and easy to read membrane chromatographic immunoassay with no need for instrument. The method employs a unique combination of monoclonal and polyclonal antibodies to specifically identify Morphine in urine with a high degree of sensitivity.

Morphine, one of opiates�¢?? derivatives, is central nervous system stimulants that produce alertness, wakefulness, increased energy, reduced hunger, and an overall feeling of well-being. Morphine has been the preferred drug for the management of pain in cases of advanced cancer and other severe conditions. Morphine and other Opiates�¢?? metabolites may be detected in urine as a result of heroin morphine, codeine, or poppy seed intake. Administration of large doses of Morphine can cause tolerance and physiological dependence in users, and can lead to substance abuse. D-Morphine is controlled substances. GC/MS or immunoassay method has been developed for the determination of 300ng/ml for Morphine.

MOR Test PRINCIPLE

During a test labeled antibody-dye conjugate mixes with urine specimen and binds to the free drug if it is presented in the sample, to form an antibody-antigen complex. This complex prevents the formation of pink color bands in the test zone of the dip-stick if drug to be detected in specimen is above the detection levels (300ng/ml for Morphine). In case of absent of drug and its metabolites, unbound dye conjugate will bind to the antigens immobilized in the test zone to form a pink reaction line. To serve as a quality control for the assay, another pink line will always appears in the test zone regardless positive or negative result.

Packaging Details:
Pouch+Box+Carton packaging

(1) With our company's Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Antibiotics Residue In Milk Rapid Test(Beta lactam & Tetracycline Rapid Test)

INTENDED USE

Beta lactam + Tetracycline Rapid Test is a competitive immunoassay for the semi-quantitative detection of the presence of Beta lactam and Tetracycline residue in milk.

KIT COMPONENT

1.6 plastic canister each containing 8 microwells and 8 strips

2.48 pipettes

3.Product Manual

Package:8 Strips/Bottle , 48 Strips/Box
Packaging Details:
Pouch+Box+Carton packaging

(1) With our companyâ??s Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Anna Lee

Int'l Market Executive
SPANBIO
Tel: +86(755)89589611
Cell Phone:+8613417551798(WhatsApp)
anna.lee@spanbio.com

The Cytomegalovirus Rapid Test is a rapid qualitative lateral flow test designed for the quantitive detection of Cytomegalovirus (CMV) in human serum/plasma samples.

Cytomegalovirus is a herpes virus and a leading biological factor causing congenital abnormalities and complications among those who receive massive blood transfusions and immunosuppressive therapy. About half of the number of pregnant women who contract a primary infection, spread the disease to their fetus. When acquired in-utero, the infection may cause mental retardation, blindness, and/or deafness. Serological tests for detecting the presence of antibody to CMV can provide valuable information regarding the history of previous infection, diagnosis or active or recent infection, as well as in screening blood for transfusions in newborns and immuno-compromised recipients.

The Cytomegalovirus Rapid Test Device (Serum/Plasma) has been designed to detect CMV through visual interpretation of color development in the internal strip. The membrane was immobilized with antigens of CMV on the test region. During the test, the specimen is allowed to react with colored recombinant mouse anti-human IgM latex conjugates, which were precoated on the sample pad of the test. The mixture then moves on the membrane by a capillary action, and interact with reagents on the membrane. If there were enough CMV antibodies in specimens, a colored band will from at the test region of the membrane. Presence of this colored band indicates a positive result, while its absence indicates a negative result. Appearance of a colored band at the control region serves as a procedural control. This indicates that proper volume of specimen has been added and membrane wicking has occurred.

General Information
One-Step HBsAg Rapid Test is to detect the Hepatitis B Virus Surface Antigen in serum, plasma or whole blood.
Analytical sensitivity : 1ng/ml of HBsAg
Sensitivity :100% , Specificity : 100%
Specimen : Serum , Plasma or Whole Blood
Reading Time : 10 min

General Information
One-Step Chikungunya IgG/IgM Rapid Test is detection of IgG and IgM anti-chikungunya virus CHIK in human blood.
Sensitivity: 90.3% , Specificity: 100%
Specimen : Serum, Plasma or Whole Blood
Reading Time : 10 min

General Information
One-Step Leishmania IgG/IgM Rapid Test is detection antibodies IgG and IgM to the subspecies of the Leishmania donovani (L. donovani), the Visceral leishmaniasis causative protozoans in human blood.
Sensitivity: 91.2 % , Specificity: 99.5%
Specimen : Serum, Plasma or Whole Blood
Reading Time : 10 min

General Information
One-Step H.Pylori Ab Rapid Test is to detect the antibodies against H. pylori in serum, plasma or whole blood.
For H.Pylori Ab Rapid tests:
Sensitivity: 98.9 %, Specificity: 98.5%,
Specimen: Serum, Plasma or Whole Blood
Reading Time: 10 min

General Information
One-Step H.Pylori Ag Rapid Test is to detect the antigens in stool.
For H.Pylori Ag Rapid tests:
Sensitivity: 98.9 %, Specificity: 98.5%,
Specimen: Stool
Reading Time: 10 min

General Information
The CRP C-Reactive Protein Semi-Quantitative Rapid Test utilizes a combination of colloidal gold conjugate and anti-CRP antibodies to selectively detect CRP in human blood.
Sensitivity:97% , Specificity:96.9%
Specimen : Serum, Plasma or Whole Blood
Reading Time : 10 -15min

General Information
One-Step Chloramphenicol Rapid Test is a competitive immunoassay for the semi-quantitative detection of the presence of Chloramphenicol residue in milk, Honey,Tissue extract and Aquatic products.
Detection limit: Milk 0.3ppb ,Honey 0.3ppb , Tissue extract 0.3ppb , Aquatic products 0.3ppb
Specimen: Defatted milk, Honey, Tissue extract, Aquatic products
Reading Time : 5-10min

General Information
Items : MOR/MET/THC/AMP/MDMA/MTD/COC/TCA/BAR/BZO, up to 15 kinds of Drug Tests
Format: Strip, Cassette, Cup,and Panel
Specimen: Urine
Packaging Details:
Pouch+Box+Carton packaging

(1) With our companyâ??s Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Anna Lee

Int'l Market Executive
SPANBIO
T

General Information
One-Step Canine Influenza Virus Ag Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of canine Influenza virus (CIV Ag) in dog secretions.
Sensitivity: 94.7% , Specificity: 100%
Specimen: Secretions
Reading Timen:5-10 min

General Information
Method: Double Antibodies Sandwich Method
Sensitivity : 99.8%
Specificity : 99.6%
Specimen : Canine feces or vomit
Detection limit: 103 TCID50 / mL
No cross reaction against CDV, CCV, CRV, CAV - I, Giardia
Reading Time : 5- 10 min

General Information
One-Step Streptomycin Rapid Test is a competitive immunoassay for the semi-quantitative detection of the presence of Streptomycin residue in milk,honey and aquatic product .
Detection limit:Milk 100ppb , Honey 10ppb , Aquatic product 100ppb
Specimen: Defatted Milk, Honey,Aquatic products
Reading Time : 5-10 min

Canine Distemper Virus Ag Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of canine Distemper virus (CDV Ag) in dog secretions or serum.
Assay Time: 5-10 min
Sample: secretions or serum


25PCS/BOX

INTENDED USE

Canine Parvovirus Ag Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of canine Parvovirus (CPV Ag) in dog��s feces or vomit.

Assay Time: 5-10 min
Sample: Feces or vomit



25 PCS/BOX

General Information
One-Step HCV Rapid Test is to detect the antibodies to HCV in human serum, plasma or whole blood.
Applied highly purified recombinant proteins : Core,NS3,NS4,NS5
Method; Double Antigens Sandwich Method, the 4th generation Rapid Tests
Sensitivity : 100%, Specificity : 100%
Specimen : Serum, Plasma or Whole Blood
Reading Time : 10 min.

General Information
One-Step Syphilis Rapid Test is to detect the antibodies against syphilis in serum, plasma or whole blood.
Advantage: No need diluent for whole blood test
Method; Double Antigens Sandwich Method
Sensitivity : 100% , Specificity : 100%
Specimen: Serum , Plasma or Whole Blood
Reading Time : 10 min

General Information
One-Step HAV Rapid Test is immunochromatographic assay for the diagnosic of Hepatitis A and the detection of Antibodies to HAV.
Sensitivity : 99.4.0% , Specificity : 99.5%
Specimen : Serum, Plasma or Whole Blood
Reading Time : 20 min

General Information
One-Step Influenza A/B Test is detection influenza type A and type B nucleoprotein antigen extracted from the nasal swab specimen.
Sensitivity : 91.3% , Specificity : 95.7%
Detection limit:5.1x105TCID50/ml
Specimen: Nasal Swab
Reading Time : 15-20min

General Information
One-Step Dengue Rapid Test is to detect IgG&IgM antibodies in serum, plasma or whole blood.
For Dengue IgG/IgM Ab test:
Sensitivity : 99.9% , Specificity : 99.5%
Specimen : Serum , Plasma and Whole Blood
Reading Time : 10 min

General Information
One-Step Rotavirus Rapid Test (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of rotavirus in human fecal specimens.
Sensitivity: 99.1% , Specificity: 99.9%
Detection limit:103.5TCID50/ml
Specimen: Feces
Reading Time : 10min

General Information
One-Step Adenovirus Rapid Test (Feces) is a rapid visual immunoassay for the qualitative presumptive detection of adenovirus in human fecal specimens.
Sensitivity: 98.7% , Specificity: 98.0%
Detection limit:1.37s/CO
Specimen: Feces
Reading Time : 10min

General Information
The CRP Semi-Quantitative Rapid Test utilizes a combination of colloidal gold conjugate and anti-CRP antibodies to selectively detect CRP in human blood.
Sensitivity:97% , Specificity:96.9%
Specimen : Serum, Plasma or Whole Blood
Reading Time : 10 -15min

General Information
One-Step Sulfonamides Rapid Test is a competitive immunoassay for the semi-quantitative detection of the presence of Sulfonamides residue in Milk,Honey,Tissue extract and Aquatic products.
Specimen: Milk, Honey, Tissue extract, Aquatic products
Reading Time : 5-10 min

INTENDED USE
Canine Distemper Virus Ag Test is a sandwich lateral flow immunochromatographic assay for the qualitative
detection of canine Distemper virus (CDV Ag) in dog's secretions or serum.
Assay Time: 5-10 min
Sample: secretions or serum
PRINCIPLE
Canine Distemper Virus Ag Test is based on sandwich lateral flow immunochromatographic assay. The test
device has a testing window. The testing window has an invisible T (test) zone and C (control) zone. When
sample is applied into the sample hole on the device, the liquid will laterally flow on the surface of the test
strip. If there is enough Distemper antigen in the sample, a visible T band will appear. The C band should
always appear after a sample is applied, indicating a valid result. By this means, the device can accurately
indicate the presence of Canine Distemper antigen in the sample.

INTENDED USE

THE ONE STEP ANTI-DENGUE (IGM & IGG) TRI-LINE TEST IS A COLLOIDAL GOLD ENHANCED, RAPID IMMUNOCHROMATOGRAPHIC ASSAY FOR THE QUALITATIVE DETECTION OF ANTIBODIES (IGM & IGG) TO DENGUE VIRUS (DV) IN HUMAN WHOLE BLOOD, SERUM OR PLASMA. THIS TEST IS A SCREENING TEST, AND ALL POSITIVES MUST BE CONFIRMED USING AN ALTERNATE TEST SUCH AS WESTERN BLOT. THE TEST IS INTENDED FOR HEALTHCARE PROFESSIONAL USE ONLY.


25PCS/BOX

INTENDED USE

Giardia Ag Feces Rapid Test is a sandwich lateral flow immunochromatographic assay for the qualitative detection of Giardia antigen in feces.
Assay Time: 5-10 min
Sample: Feces


25PCS/BOX

Uncut Sheet Influenza A/B Rapid Test

Specimen:nasal swab

Intended Use

The Influenza A +B Test is a rapid chromatographic immunoassay for the qualitative detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. This kit is intended to be used as an aid in the diagnosis of influenza A and influenza B virus in nasal swab specimens.

Principle

The Influenza A +B Test is a qualitative membrane strip based immunoassay for the detection of influenza type A and B nucleoprotein antigens in nasopharyngeal swab and nasal aspirate specimens. In this test procedure, influenza type A antibody is immobilized in the A line, influenza type B antibody is immobilized in the B line. After a specimen is placed in the specimen well, it reacts with influenza type A antibody and/or B antibody coated particles that have been applied to the specimen pad. This mixture migrates chromatographically along the length of the test strip and interacts with the immobilized antibody. If the specimen contains influenza type A, a colored line will appear in the A line region indicating a influenza type A positive result. If the specimen contains influenza type B, a colored line will appear in the B line region indicating a influenza type B positive result. Absence of any T lines (A and B) suggests a negative result. To serve as a procedural control, a colored line will always appear at the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.

Storage and Stability

1.Store as packaged in the sealed pouch at room temperature or refrigerated (4-30 or 40-86). The test device is stable through the expiration date printed on the sealed pouch.

2.The test must remain in the sealed pouch until use.

Uncut Sheet HIV 1/2 Tri-Lines Rapid Test

Package:30sheets/pouch

Specimen:Whole blood/Serum/plasma

INTENDED USE

The HIV-1/2 Rapid Screen Test (RST) is a qualitative test for the detection of antibodies to Human Immunodeficiency Virus type 1 and 2(HIV-1/2) in human serum/plasma and whole blood. It is considered as an initial screening test for HIV-1/2 antibodies. All positive specimens must be confirmed with Western Blot or other qualified EIA.

PRECAUTION

1.For in vitro diagnostic uses only.

2.All patient samples should be treated as if capable of transmitting diseases.

3.Do not use test kit beyond expiration date.

4.Icteric, lipemic, hemolysed, heat treated and contaminated sera may cause erroneous results.

SUMMARY AND EXPLANATION OF THE TEST

It has been shown that the acquired immunodeficiency syndrome (AIDS) is caused by viruses transmitted by sexual contact, transfusion, use of contaminated blood products and sharing contaminated needles. HIV-1 and HIV-2 viruses have been isolated from patients with AIDS and AIDS-related complex (ARC), high-risk persons for AIDS. HIV-1 and HIV-2 viruses delete T helper cells, a subpopulation of T cells for body defense, thus causing AIDS patients susceptible to opportunistic infections and developing malignant tumors. The incidence of specific antibodies to HIV-1/2 is high in AIDS, ARC and persons with high risk for AIDS. The HIV-1/2 Rapid Screen Test is designed to detect antibodies to HIV-1/2 in AIDS patients, ARC or high risk persons and identify any potential donors carrying these antibodies in serum specimens.

PRINCIPLE

HIV-1/2 RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HIV-1/2 in human serum/plasma and whole blood. HIV-1/2 specific antigens are precoated onto membrane as a capture reagent on the test region. During the test, specimen is allowed to react with the colloidal gold particles, which have been labeled with HIV-1/2 specific antigens. Antibodies to HIV-1/2, if present, a red colored band will develop on the membrane in proportion to the amount of HIV-1/2 antibodies present in the specimen. Absence of this red colored band in the test region suggests a negative result. To serve as a procedural control, red colored band in the control region will always appear regardless the presence of antibodies to HIV-1/2.

Product Name: Coronavirus (COVID-19) Antigen Rapid Test Cassette (Swab), COVID-19 Antigen Test Kit, SARS COV 2 Variant Test Kits

Sample type Throat OR nasal swab

Detection type Qualitative

Method: Colloidal Gold Rapid Test

Function: Diagnose

Certificate: ISO9001/ ISO13485/CE

Format: Strip, Cassette, Midstream

Sensitivity: 96.23%

Specificity: 99.11%

Accuracy: 98.56%

Reading time: 15 minutes

Packaging Details:

Pouch+Box+Carton packaging

(1) With our company's Logo

(2) With the natural package

(3) With OEM package

(4) ODM

Product Name: Coronavirus (COVID-19) Antigen Rapid Test Cassette (Swab), COVID-19 Antigen Test Kit, SARS COV 2 Variant Test Kits

Sample type Throat OR nasal swab

Detection type Qualitative

Method: Colloidal Gold Rapid Test

Function: Diagnose

Certificate: ISO9001/ ISO13485/CE

Format: Cassette

Sensitivity: 96.23%

Specificity: 99.11%

Accuracy: 98.56%

Reading time: 15 minutes

Packaging Details:

Pouch+Box+Carton packaging

(1) With our company's Logo

(2) With the natural package

(3) With OEM package

(4) ODM

INTENDED USE

The One Step Dengue NS1 Ag Test is a rapid chromatographic immunoassay for the qualitative detection of dengue virus NS1 antigen in serum or plasma to aid in the diagnosis of Dengue viral infection.

SUMMARY

Dengue is transmitted by the bite of an Aedes mosquito infected with any one of the four dengue viruses. It occurs in tropical and sub-tropical areas of the world. Symptoms appear 3 14 days after the infective bite. Dengue fever is a febrile illness that affects infants, young children and adults. Dengue haemorrhagic fever (fever, abdominal pain, vomiting, bleeding) is a potentially lethal complication, affecting mainly children. Early clinical diagnosis and careful clinical management by experienced physicians and nurses increase survival of patients. One step Dengue NS1 Ag Test is a simple, visual qualitative test that detects dengue virus NS1 antigen in human serum or plasma. The test is based on immunochromatography and can give a result within 15 minutes.


25PCS/BOX