For the qualitative detection of Hepatitis B surface antigen in serum or plasma.

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 or plasma.

PRINCIPLE

The HBsAg RST is a chromatographic immunoassay (CIA) for the detection of surface antigens of Hepatitis B in human serum or plasma. 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 other specific antibodies. If HBsAg 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 of HBsAg.

REAGENTS AND MATERIALS PROVIDED

1.          One pouched cassette with desiccant.

2.          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 ontaminated 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).

INTERPRETATION OF RESULTS

 

Negative: No band in the test region (T), only one pink band appears in the control region (C). This indicates that no HBsAg have been detected.

Positive: In addition to the band in the control region (C), another pink band will appear in the test region (T). This indicates that the specimen contains HBsAg.

Invalid: If no band appears in the control region(C), regardless of the presence or absence of line in the test region (T). It indicates a possible error in performing the test. The test should be repeated using a new device.

LIMITATION OF THE PROCEDURE

1.  The test is to be used for the qualitative detection of HBsAg.

2.  A negative result does not rule out infection by Hepatitis B because the HBsAg may not be present in sufficient quality.

 

 

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10th and 11th Five-Year Plan and Faculty of Life Sciences of HuBei University. SpanBio also housed a R&D team that is developing gene recombination, cell cultivation and protein purification techniques. SpanBio pays strict attention on rapid tests for human being, animal diseases and food safety detection. It provides a number of customized services to professional distributors and partnering affiliates with excellent quality, competitive prices and super service.
Efficiently structured to provide lasting and economic health care solutions with export ready goods, our main products cover the following immunodiagnostic rapid test kits:
Rapid Tests for Human Use :
1) Fertility: Pregnancy HCG, ovulation LH, menopause FSH
2) Infectious diseases: Hepatitis B, HCV, HIV
3) Drug abuse: AMP, BAR, BZO, COC, mAMP, MOP, MTD, OPI, PCP, TCA, THC
4) Tumor markers: CEA, PSA, AFP, FOB
5) STDs(Sexually Transmitted Diseases): Gonorrhea, syphilis, chlamydia
6) New products: Malaria, H. Pylori, Multi-Hepatis B Panel (HBsAg, Anti-HBs, HBeAg, Anti-HBe, Anti-HBc), Blood Glucose Test, Multi-drug of Abuse Panel, Avian (Bird) Flu Rapid Test, etc.
Rapid Tests for Veterinary :
1) Bovine: Cow Pregnancy , Cow Ovulation, Bovine Brucella, Bovine Tuberculosis ,Food and Mouth Disease NSP Ab Test
2) Canine: Canine Distemper, Canine Parvovirus, Canine Coronavirus
3) Feline : Feline Leukemia Virus Ag Rapid Test ,Feline Panleucopenia Virus Ag Test,Feline Immunodeficiency Virus Ab Test
Rapid Tests for Food Safety :
1)For Antibiotics Residue : Nitrofurans (AOZ,AMOZ, AHD, SEM), Streptomycin , Sulfonamides , Chloramphenicol , Quinolone , Beta-Lactam&Tetracycline Combo (2 in 1), β-Lactams & Streptomycin & Chloramphenicol & Tetracyclines Combo (4 in 1), Beta-Lactam, Tetracycline test
2) For Beta-Agonist Residue : Ractopamine, Clenbuterol ,Salbutamol