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
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
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.
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
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.
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
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 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)
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 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.
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.
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).
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.
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.
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..
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.
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).
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).
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).
