HEV IgM Test Colloidal Gold Rapid Test Strip Serum Specimen

HEV-IgM Rapid test

Catalog No.: BG702C

INTENDED USE

This test is a single use, rapid device intended for qualitative detection of IgM-class antibodies to hepatitis E virus (HEV) in serum, plasma samples. It is intended to be used in clinical laboratories for diagnosis of acute hepatitis E and management of patients related to infection with hepatitis E virus.

SUMMARY

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.

COMPONENTS

Forty tests/kit
40 HEV IgM colloidal gold rapid test strips, each placed in white plastic cassette and packed in foil pouch, Instructions for Use, 5ml×1 dilution tubes.
Materials required but not provided: Safety lancet, alcohol Prep-Pad, Disposable Pipette, clock or timer, specimen collection container, centrifuge, biohazard waste container

ASSAY PROCEDURE

Allow the test cassette to reach room temperature (appropriately 30minutes) before opening the pouch. Add one drop (approximately 10μL) serum/plasma sample and two drops diluent (about 100μL) into the sample dilution tube by using the sample dispenser and mix completely. Then, open the pouch and pipette the dilute sample into the sample well. Avoid dropping sample in the observation window. Do not allow the sample to overflow.
Place the cassette on flat surface and read the results within 15-20 minutes. DO NOT INTERPRET RESULT AFTER 20 MINUTES.

RESULTS

Quality Control: One red line will always appear next to the Control Zone(C) indicating the validity of the test. If no red line appears, the test is invalid - discard the test and repeat with new sample and new cassette.
Positive Results: One red line next to the Test Zone (T) indicates that IgM antibodies to HEV have been detected using this HEV IgM Rapid Test.
Negative Results: No red line appears within 10 minutes next to the Test Zone (T) indicating that no IgM antibodies to HEV have been detected with this HEV IgM Rapid Test. However, this does not exclude the possibility from infection with HEV.

The positive result obtained with this HEV IgM Rapid Test alone cannot be the final diagnosis of HEV. Any positive result must be interpreted in onjunction with the patient clinical history and another laboratory testing results. Follow-up and supplementary testing of any positive samples with other analytical system (e.g. ELISA, WB) is required to confirm any positive result.

Biovantion Inc is independent from international department of Bioneovan Co., Ltd., which established in 2 0 0 5, is an in vitro diagnostic reagents manufacturer engaged in the research, development, production, and focus on clinical testing for infectious diseases, such as Hepatitis virus, Noro virus, Parvo virus test kits, our products include rapid test cassette and Elisa kits.

All our products have been registered in National Medical Products Administration of China, in year 2020 we get Certificate of ISO 13485:2016 – QUALITY MANAGEMENT SYSTEMS FOR MEDICAL DEVICES from SGS. More importantly, we have awarded the registration certificate from National Medical Products Administration for Diagnostic Kit for IgM Antibody to COVID-19 and IgG antibody to COVID-19 during the outbreak in China, and also we developed COVID-19 Antigen test ; Neutralizing Antibody Test, these products selling well all overthe world