HEV IgM
HEV IgM
Batch Details
Batch Details
Lot No. : 022/06/2024/002
Mfg. : 06/2024
Exp. : 05/2026
Hepatitis E, a major form of enterically transmitted hepatitis. 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 IgM is detected in >90% of patients and persists for 3 months. Anti-HEV IgM is also a well-established marker of recent infection and is the most convenient one for diagnosis. Reliable techniques for anti-HEV IgM 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 IgM Rapid Test is designed to detect anti-HEV IgM in human serum or plasma. It can be performed within 15 minutes by minimally skilled personnel without laboratory equipment.
Check HERE Instructions For Use (Pack Insert)
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Importance to know
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Warnings and Precautions
- Please read the instruction carefully before performing the test.
- Do not use the test after the expiration date.
- Immediately carry out the test after removing the test device from the pouch.
- Do not mix or interchange the specimen sample.
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Limitation
- For in vitro diagnostic use only; detects HEV antibodies in serum or plasma.
- This test detects the presence of IgM antibodies to HEV in the specimen and should not be used as the sole criterion for the diagnosis of Hepatitis E.
- If the test result is negative and clinical symptoms persist, additional follow-up testing using other clinical methods is recommended. Also a negative results dose not preclude the possibility of an infection of Hepatitis E.