TABLE 2.
Information for HEV antibody assays tested in this studya
| Manufacturer | Product | Intended use | Antigen (origin) | Test vol (dilution) | Cutoff (unit) |
|---|---|---|---|---|---|
| In-house | Research | ORF2 (genotype 3) | 50 μL (1:100) | Negative: <1 (COI) | |
| Positive: ≥1 (COI) | |||||
| Mikrogen | RecomWell HEV IgG/IgM | Research | ORF2 (genotype 1 and 3) | 100 μL (1:100) | Negative: <20 (U/mL) |
| Borderline: ≤20 to ≤24 (U/mL) | |||||
| Positive: >24 (U/mL) | |||||
| Inst Immunol | IgG/IgM anti-HEV EIA | Research | ORF2 (genotype 4) | 50 μL (1:100) | Negative: <1 (COI) |
| Immunis IgA anti-HEV EIA | Diagnosisb | Positive: ≥1 (COI) | |||
| MP | MP Diagnostics HEV IgM ELISA 3.0 | Research | ORF2 (genotype 1) | 210 μL (1:20) | Negative: <0.4 + NRC (COV) |
| Positive: ≥0.4 + NRC (COV) | |||||
| Wantai | Wantai HEV-IgM ELISA | Research | ORF2 (highly conserved region) | 110 μL (1:10) | Negative: <1 (A/CO) |
| Positive: ≥1 (A/CO) |
a
A/CO, absorbance/cutoff; A/COI, absorbance/cutoff index; COI, cutoff index; COV, cutoff value; EIA, enzyme immunoassay; ELISA, enzyme-linked immunosorbent assay; HEV, hepatitis E virus; NRC, nonreactive control mean; ORF, open reading frame.
b
Approved in Japan.