Diagnostic Kit for Hepatitis E Virus Antibody (Colloidal Gold)

Diagnostic Kit for Hepatitis E Virus Antibody (Colloidal Gold)

INTENDED USE

The HEV Gold Rapid Screen Test (RST) is a Chromatographic immunoassay (CIA) for direct qualitative detection of antibodies to Hepatitis E type virus (HEV) in human serum/ plasma.

PRINCIPLE

HEV RST is a chromatographic immunoassay (CIA) for the detection of antibodies to HEV in human serum/plasma. Mouse anti human-IgM µ strands 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 HEV recombinant antigens. If antibodies to HEV are present, a pink colored band will develop on the membrane in proportion to the amount of HEV 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 pink colored band in the control region will always appear regardless the presence of antibodies to HEV.

REAGENTS AND MATERIALS PROVIDED

1.One sealed pouched cassette with desiccant & disposable pipettet.

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

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

STORAGE AND STABILITY

Store HEV Rapid Screen Test at temperature ranges 4-30 °C in the sealed pouch. Refer to the expiration date for stability. Do not freeze.

LIMITATION OF THE PROCEDURE

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

2.A negative result does not rule out infection by HEV because the antibodies to HEV may be absent or may not be present in sufficient quantity to be detected at early stage of infection.

Span Biotech Ltd. is a research based company for rapid tests, with strong support from National Key Laboratory of Technology Projects of 10^th and 11^th 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.

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• Always best of all and always pay attention to innovation.
• Special customized service tightly following customers’ requests.
• Integrated excellent quality, competitive prices and super service together.