Enssure HEV Rapid Test Kit

HEV IgM

Product Information

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.

Principle

The HEV lgM Rapid Test is a lateral flow chromatographic immunoassay with a cassette device. The test strip includes a colored conjugate pad with HEV antigens and control antibodies conjugated with colloidal gold. The nitrocellulose membrane strip features a test line (T line) coated with monoclonal anti-human lgM antibody and a control line (C line) coated with a control line antibody. Upon dispensing a test specimen, anti-HEV lgM, if present, binds to HEV conjugates, forming a colored T line, indicating a positive result. The internal control line (C line) ensures test validity by exhibiting a colored line regardless of T line development. An absence of the T line suggests a negative result, and an invalid result prompts retesting with a new device.

Testing Procedure

Importance to know

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.

Limitation

• The HEV lgM Rapid Test is for qualitative detection only; test line intensity does not correlate linearly with antibody titer.

• A negative result indicates no detectable anti-HEV lgM but does not rule out exposure or infection.

• Low antibody quantity or timing of sample collection can yield false negatives.

• High levels of heterophile antibodies or rheumatoid factor may impact results.

• Rapid progression of infection may yield a negative result; consider alternative tests if symptoms persist.

• Interpret results in conjunction with other diagnostic methods and clinical findings.