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. 2016 Aug 22;8(8):232. doi: 10.3390/v8080232

Table 1.

Overview of specifications for the different HEV immunoassays.

Anti-HEV ELISA Assay Type Antigen/Origin Analysis and Serostatus Interpretation
IgM assays
Wantai HEV IgM ELISA (Sanbio 1) qualitative, µ-chain capture recombinant antigen ORF-2 C-terminal, genotype 4 [30]
  • -

    negative: C.O. < 0.9

  • -

    borderline: C.O. 0.9–1.1

  • -

    positive: C.O. ≥ 1.1
recomWell HEV IgM (Mikrogen GmbH 2), new version (08/2012) quantitative, indirect recombinant antigen ORF-3 C-terminal, genotype 1, 2 and 3 [22]
  • -

    negative: <20 U/mL

  • -

    borderline: ≤20 to ≤24 U/mL

  • -

    positive: >24 U/mL
HEV IgM ELISA 3.0 (MP Biomedicals 3) qualitative, indirect 1 recombinant antigen, ORF-2 C-terminal (Chinese strain), genotype 1
  • -

    negative: C.O. < 0.4 + NRC

  • -

    positive: C.O. ≥ 0.4 + NRC
Assure HEV IgM Rapid Test (MP Biomedical 3) qualitative, reverse-flow immunochr 1 recombinant antigen, ORF-2 C-terminal (Chinese strain), genotype 1
  • -

    positive: test-line and control-line

  • -

    negative: control-line
Anti-HEV ELISA (IgM, Euroimmun 4) qualitative, indirect 1 recombinant antigen ORF-2 (USA strain), genotype 3
  • -

    ratio: extinction sample/calibrator

  • -

    negative: ratio < 0.8

  • -

    borderline: ratio ≥ 0.8 to ≤ 1.1

  • -

    positive: ratio ≥ 1.1
All antibody assays (IgA, IgM, IgG)
HEV ELISA 4.0 (MP Biomedicals) qualitative, direct 1 recombinant antigen, ORF-2 C-terminal (Chinese strain), genotype 1
  • -

    negative: C.O. < 0.4 + NRC

  • -

    positive: C.O. ≥ 0.4 + NRC
IgG assays
Wantai HEV IgG ELISA (Sanbio 1) qualitative, indirect recombinant antigen ORF-2 C-terminal, genotype 4 [30]
  • -

    negative: C.O. < 0.9

  • -

    borderline: C.O. < 0.9–1.1

  • -

    positive: C.O. ≥ 1.1
recomWell HEV IgG (Mikrogen GmbH 2) quantitative, indirect recombinant antigen ORF-2 C-terminal, genotype 1 and 3
  • -

    negative: <20 U/mL

  • -

    borderline: ≤20 to ≤24 U/mL

  • -

    positive: >24 U/mL
HEV ELISA (MP Biomedicals 3) qualitative 3 recombinant antigens, ORF 2 and ORF 3 (Burmese, Mexican strains), genotype 1 and US type 2
  • -

    negative: C.O. < 0.5 + NRC

  • -

    positive: C.O. ≥ 0.5 + NRC
Anti-HEV ELISA (IgG, Euroimmun 4) quantitative (IU/mL), indirect 1 recombinant antigen ORF-2 (USA strain), genotype 3
  • -

    negative: <0.8 IU/mL

  • -

    borderline: ≥0.8 to <1.1 IU/mL

  • -

    positive: ≥1.1 IU/mL

1 Sanbio B.V., Uden, The Netherlands; 2 Mikrogen GmbH, Neuried, Germany; 3 MP Biomedicals Europe, Illkirch Cedex, France (previously distributed by Genelabs); 4 Euroimmun AG, Lübeck, Germany. HEV: hepatitis E virus; ELISA: enzyme-linked immunosorbent assay; Ig: immunoglobulin; ORF: open reading frame; IU: international unit; C.O.: cut-off; NRC: non-reactive control.