HEV Hepatitis E Virus IgM Rapid Test

INTENDED USE
HAV IgG/IgM Rapid Detection Kit (Colloidal Gold Method) is a lateral flow immunoassay for the qualitative detection of antibodies (IgG and IgM) to Hepatitis A Virus (HAV) in serum, plasma or whole blood samples. It is intended to be used as a screening test and provides a preliminary test result for early diagnosis and management of patients related to infection with Hepatitis A Virus.The Hepatitis E Virus Antibody IgM Test is a rapid chromatographic immunoassay for the qualitative detection of IgM antibodies to HEV in Whole Blood/Serum/Plasma to aid in the diagnosis of HEV infection. The test is based on immunochromatography and can give a result within 15 minutes. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be combined to confirm the test result obtained by this device.
Test Principle
The test card contains: If the sample contains an IgG/IgM antibody of HAV, the antibody will bind to the colloidal gold-labeled HAV antigen, and the immune complex will be captured by the monoclonal anti-human IgG/IgM antibody immobilized on the nitrocellulose membrane to form a purple/red T line , showing that the sample is positive for IgG/IgM antibody.

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 70μl) and start the timer. See illustration below.

Materials Provided: 

Specification: 1T/box,20T/box,25T/box,50T/box

 Results

Positive: *Two lines appear. One colored line should be in the control region (C), and another apparent colored line adjacent should be in the test region (T).

Negative: One colored line appears in the control region (C). No line appears in the test region (T).

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 using a new test cassette.

If the problem persists, discontinue using the lot immediately and contact your local distributor.