ALL TEST™ HEV IgG/IgM Rapid Test Cassette

The HEV IgG/IgM Rapid Test Cassette is a qualitative, lateral flow immunoassay designed to detect IgG and IgM antibodies against Hepatitis E Virus (HEV) in human serum or plasma. This point-of-care test supports early and accurate diagnosis of HEV infection in clinical settings.

Principle of the Test

This test utilizes HEV antigen-coated particles and anti-human IgM/IgG capture antibodies immobilized on the membrane:

• IgG Detection: Anti-human IgG captures IgG–antigen complexes, forming a visible colored line.
• IgM Detection: Anti-human IgM captures IgM–antigen complexes, forming a separate colored line.
• A control line confirms proper sample flow and test validity.

Key Features

• Detects IgG and/or IgM antibodies to HEV
• Three-band format: IgM line, IgG line, and Control line
• Time to results: 15 minutes
• Sample volume: 1 drop (~25 µL) of serum/plasma + 1 drop (~40 µL) of buffer
• Storage: 2–30°C; do not freeze
• Certifications: CE marked; for professional diagnostic use

Interpretation of Results

Performance Summary

Compared with a leading ELISA HEV assay:

IgG Results (n=172)

• Sensitivity: 90.0% (95% CI: 68.3%–98.8%)
• Specificity: 98.7% (95% CI: 95.3%–99.8%)
• Accuracy: 97.7%

IgM Results (n=237)

• Sensitivity: 93.3% (95% CI: 77.9%–99.2%)
• Specificity: 98.6% (95% CI: 95.8%–99.7%)
• Accuracy: 97.9%

Materials Provided

• Test cassettes
• Droppers
• Buffer
• Package insert

Not included: Centrifuge, specimen collection containers, timer

Specimen Handling

• Use serum or plasma only
• Store samples at 2–8°C for ≤3 days, or ≤–20°C for long-term storage
• Avoid hemolysis, repeated freeze-thaw cycles, and direct sunlight

Limitations

• Negative results do not exclude early infection
• Not suitable for use with cadaver samples, urine, saliva, or pooled blood
• Results are qualitative only—not for quantifying antibody levels
• False positives may occur due to sample quality or improper storage