One Step HEV IgM/IgG Rapid Test

One Step HEV IgM Rapid Test

Summary

Hepatitis E is an acute, usually self-limiting disease of the liver caused by hepatitis E virus (HEV). HEV is transmitted from person to person, primarily by the faecal-oral route. The incidence of hepatitis E is closely related to socioeconomic development, and seroepidemiological studies show that prevalence of anti-HEV antibodies in the general population varies from 15% to close to 100% in different parts of the world. One step HEV IgM Test is a simple, visual qualitative test that detects Hepatitis E Virus IgM antibodies in human Whole Blood /Serum / Plasma. The test is based on immunochromatography and can give a result within 15 minutes.  

Principle

The One Step HEV IgM Test is a qualitative membrane strip based immunoassay for the detection of Hepatitis E Virus IgM antibodies in Whole Blood /Serum / Plasma. The test device consists of: 1) a burgundy colored conjugate pad containing HEV recombinant envelope antigens conjugated with Colloid gold (HEV conjugates) and rabbit IgG-gold conjugates,2) a nitrocellulose membrane strip containing a test band (T band) and a control band (C band). The T band is pre-coated with the antibody for the detection of IgM anti-HEV, and the C band is pre-coated with goat anti rabbit IgG. When an adequate volume of test specimen is dispensed into the sample well of the test strip, the specimen migrates by capillary action across the strip. IgM anti-HEV if present in the specimen will bind to the HEV conjugates. The immunocomplex is then captured by the reagent coated on the T band, forming a burgundy colored T band, indicating a HEV IgM positive test result and suggesting a fresh infection. Absence of T band suggests a negative result. The test contains an internal control (C band) which should exhibit a burgundy colored band of the immunocomplex of goat anti rabbit IgG/rabbit IgG-gold conjugate regardless of the color development on of the T band. Otherwise, the test result is invalid and the specimen must be retested with another strip.

Storage and Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.