rapid test kit,
diagnostic tests for infection
The HEV Rapid Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of antibodies (IgG/IgM) to Hepatitis E virus (HEV) in serum or plasma.
Hepatitis E Virus (HEV) is a non-enveloped, single- stranded RNA virus identified in 1990. Infection with HEV induces acute or sub-clinical liver diseases similar to hepatitis A. HEV infections, endemic and frequently epidemic in developing countries, is seen also in developed countries in a sporadic form with or without a history of traveling to endemic area. The overall case-fatality is 0.5~3 %, and much higher (15~25 %) among
pregnant women. A hypothesis that HEV infection is a zoonosis was presented in 1995. Then a swine HEV and later an avian HEV were identified and sequenced separately in 1997 and 2001. Since then, HEV infection include anti-HEV, viremia and feces excretion of HEV was seen in a wide variety of animals, i.e., swine, rodents, wild monkeys, deer, cow, goats, dogs and chicken in both the developing and developed countries. A direct testimony was reported that the consumption of uncooked dear meat infected with HEV led to acute hepatitis E in human. And HEV genome
sequences can be detected in pork livers available in the supermarkets in Japan. With the discovery of conformational epitopes in HEV, HEV serology was further explored and understood. The phenomenon of long-lasting and protective antibodies to HEV was observed which greatly enhance the understanding to the diagnosis, epidemiology, zoonosis-related studies and vaccine development.
How to use?
Allow the test cassette, specimen, buffer and/or controls to reach room temperature (15-30°C) prior to testing.
1. Remove the test cassette from sealed pouch and used it as soon as possible. Best results will be obtained if the assay is performed immediately after opening foil pouch.
2. Absorb the sample with 25 μL dropper, then transfer 1 drop of serum/plasma (approx. 25 μL) to the sample well (S) of the test cassette.
3. Add 1 drop of buffer (approx. 40 μL) into the sample well (S) of the test cassette, start the time.
4. Read the results at 15 minutes; do not interpret after 20 minutes.
INTERPRETATION OF RESULTS
(Please refer to the illustration above)
IgG and IgM POSITIVE:* Three lines appear. One colored line should be in the control region (C) and another two colored lines should be in IgG test line region and IgM test line region. The color intensities of the lines do not have to match.
IgG POSITIVE:* Two lines appear. One colored line should be in the control line region (C), and a colored line appears in IgG test line region IgM POSITIVE:* Two lines appear. One colored line should be in the control line region (C), and a colored line appears in IgM test line region.
*NOTE: The intensity of the color in the IgG and/or IgM test line region (T) will vary depending on the concentration of HEV antibodies present in the specimen. Therefore, any shade of color in the test region (T) should be considered positive.
NEGATIVE: One colored line appears in the control region (C). No apparent colored line appears in the IgG and IgM test regions.
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 cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
|Cat. No.||Product Description||Specimen||Format||Kit Size||Cut-Off||Status|
|IHE-302||HEV IgG/IgM Rapid Test Cassette||S/P||Cassette||40 T||See Insert||Non-CE|