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Specifications:
| Application | Diagnostic Testing | ||
| Storage Temperature | Room Temperature | ||
| Product Type | Test Kit | Forms | Kit with Various components |
| Product Brand | All Test | ||
| Product Grade | Medical grade | ||
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
| Result | Interpretation |
|---|---|
| IgM+ / IgG+ / Control | Recent or acute HEV infection |
| IgM– / IgG+ / Control | Past or late-stage infection; possible immunity |
| IgM+ / IgG– / Control | Early acute HEV infection |
| Control line only | Negative for HEV antibodies |
| No control line | Invalid result; repeat test |
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