HEV IgM

Catalog No.

SHEVMSP

Specimen

S/P

Dimensions

Height: 60mm, Length: 300mm, Height: 84mm, Length: 300mm

Intended Use

The HEV lgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of anti-hepatitis E virus (HEV) lgM in human serum or plasma. It is intended to be used as a screening test by professionals and provides a preliminary test result to aid in the diagnosis of infection with HEV. Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of the health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.

Product Description

INTENDED USE

The HEV lgM Rapid Test is a lateral flow chromatographic immunoassay for the qualitative detection of anti-hepatitis E virus (HEV) lgM in human serum or plasma. It is intended to be used as a screening test by professionals and provides a preliminary test result to aid in the diagnosis of infection with HEV.
Any use or interpretation of this preliminary test result must also rely on other clinical findings and the professional judgment of the health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this device.

SUMMARY

Hepatitis E, a major form of enterically transmitted hepatitis, is widespread in many developing countries but is currently considered an emerging threat to other parts of the world. HEV is a non-enveloped, positive-sense, single-stranded RNA virus is currently classified within the family Caliciviridae. It is mainly transmitted through fecal-oral route. At least four major genotypes of HEV have been recognized: genotypes 1 and 2 are restricted to humans while genotypes 3 and 4 can infect both humans and animals. Antibody responses peak at about one month after initial infection. Antiviral lgM is detected in >90% of patients and persists for 3 months. Anti-HEV lgM is also a well-established marker of recent infection• and is the most convenient one for diagnosis.
Reliable techniques for anti-HEV lgM detection such as immunofluorescence and immune electron microscopy (IEM) have been developed. However, these techniques require labor-intensive procedures that are not available to many laboratories. The HEV lgM Rapid Test is designed to detect anti-HEV lgM in human serum or plasma. It can be performed within 15 minutes by minimally skilled personnel without laboratory equipment.

PRINCIPLE

The HEV lgM Rapid Test is a lateral flow chromatographic immunoassay. The test strip in the cassette device consists of: 1) a colored conjugate pad containing HEV antigens conjugated with colloidal gold (HEV conjugates) and a control antibody conjugated with colloidal gold, 2) a nitrocellulose membrane strip containing a test line (T line) and a control line (C line). The T line is pre-coated with monoclonal anti-human lgM antibody, and the C line is pre-coated with a control line antibody.
When an adequate volume of test specimen is dispensed into the sample well of the cassette, the specimen migrates by capillary action across the cassette. Anti-HEV lgM if present in the specimen will bind to the HEV conjugates. The immunocomplex is then captured on the membrane by the pre-coated anti-human lgM forming a colored T line, indicating a HEV lgM positive test result and suggesting an acute infection.
Absence of the test line suggests a negative result. The test contains an internal control (C line) which should exhibit a colored line of the immunocomplex of the control line antibodies regardless of color development on the T line. Otherwise, the test result is invalid and the specimen must be retested with another device.

related Products