General Information Method: Double Antigens Sandwich Method Sensitivity : 99.5% Specificity : 98.8% Specimen : Serum / Plasma Reading Time : 5- 10 min
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 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 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
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
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.
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.
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
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.
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.
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
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.
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
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.
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
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..
OneTouch Ultra Blue Blood Glucose Test Strips, 50 Ct: Test Strips, Blue Proven accuracy For blood glucose testing with the OneTouch Ultra Family of Meters and the OneTouch Ping Meter Remote. DoubleSure technology automatically checks each sample twice to confirm their result Requires just a speck of blood 1 vial of 50 test strips
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