11. Direct comparisons of test brands: convalescent phase IgG, IgG or IgM or total Ab (with around 100 samples per brand).
Study | Setting (cases) | Test method | New combined name | Antigen | Target | TP/D+ | Sensitivity | Range in percentage points |
Comparison of lateral flow assays | ||||||||
Flower 2020 [A] | Community | CGIA | Guangzhou Wondfo ‐ SARS‐CoV‐2 Ab | S‐based | IgG or IgM | 75/99a | 75.8% | 26.4 |
Flower 2020 [B] | Community | CGIA | Zhejiang Orient‐Gene IgG/IgM | N‐ and S‐based | IgG | 113/127 | 89.0% | |
Flower 2020 [C] | Community | Not detailed | Fortress Diagnostics ‐ COVID‐19 Total Ab | S‐based | IgG | 258/307 | 84.0% | |
Flower 2020 [D] | Community | Not detailed | Biopanda ‐ COVID‐19 Rapid Ab test | N‐ and S‐based | IgG | 102/163 | 62.6% | |
Flower 2020 [E] | Community | Not detailed | Mologic ‐ IgG COVID‐19 | N‐ and S‐based | IgG | 99/148 | 66.9% | |
Rudolf 2020 [A] | Unclear | CGIA | CTK OnSite COVID‐19 IgG/IgM | S‐based | IgG | 158/212 | 74.5% | 40.6 |
Rudolf 2020 [B] | Unclear | CGIA | Sure Biotech ‐ SARS‐CoV‐2 IgM/IgG Ab | N‐ and S‐based | IgG | 216/224 | 96.4% | |
Rudolf 2020 [C] | Unclear | CGIA | Augurix SimtomaX Corona Check | N‐ and S‐based | IgG | 124/220 | 56.4% | |
Rudolf 2020 [D] | Unclear | Not detailed | TAmiRNA SARS‐CoV‐2 Ab | S1‐based | IgG or IgM | 203/222 | 91.4% | |
Rudolf 2020 [E] | Unclear | Not detailed | NTBIO One Step IgG/IgM | Unclear | IgG | 188/219 | 85.8% | |
Rudolf 2020 [F] | Unclear | Not detailed | MEXACARE QuickTestCorona IgG/IgM | N‐ and S‐based | IgG | 190/224 | 84.8% | |
Rudolf 2020 [G] | Unclear | CGIA | Xiamen Biotime SARS‐Cov‐2 IgG/IgM | Unclear | IgG | 183/200 | 91.5% | |
Rudolf 2020 [H] | Unclear | Not detailed | Inzek ‐ BIOZEK COVID‐19 IgG/IgM | Unclear | IgG | 106/115 | 92.2% | |
Rudolf 2020 [I] | Unclear | CGIA | MEDsan COVID19 IgG/IgM | N‐ and S‐based | IgG | 201/227 | 88.5% | |
Rudolf 2020 [J] | Unclear | Not detailed | Qingdao HIGHTOP IgM/IgG | N‐ and S‐based | IgG | 216/229 | 94.3% | |
Rudolf 2020 [K] | Unclear | Not detailed | Hangzhou Biotest ‐ RightSign IgG/IgM | S‐based | IgG | 130/134 | 97.0% | |
Weidner 2020 [E] | Community | CGIA | MEDsan COVID19 IgG/IgM | N‐ and S‐based | IgG or IgM | 92/99a | 92.9% | 4.1 |
Weidner 2020 [F] | Community | CGIA | Wantai SARS‐CoV‐2 Ab rapid assay | RBD | IgG or IgM | 87/98a | 88.8% | |
Comparison of laboratory‐based tests | ||||||||
Chaudhuri 2020 [A] | Mixed | CLIA | Diasorin ‐ LIAISON SARS‐CoV‐2 | S‐based | IgG | 313/379 | 82.6% | 6.9 |
Chaudhuri 2020 [B] | Mixed | ELISA | Zydus Covid Kavach IgG | Unclear | IgG | 287/379 | 75.7% | |
DomBourian 2020 [A] | Unclear | ELISA | Epitope Diagnostics ‐ EDI nCov COVID‐19 | N‐based | IgG | 84/99a | 84.8% | 7.0 |
DomBourian 2020 [B] | Unclear | ELISA | EUROIMMUN ‐ anti‐SARS‐COV‐2 IgG | S1‐based | IgG | 90/98a | 91.8% | |
Gudbjartsson 2020 [A] | Community | CLIA | Roche ‐ Elecsys anti‐SARS‐CoV‐2 Ab | N‐based | Total ab | 1120/1215 | 92.2% | 46.6 |
Gudbjartsson 2020 [B] | Community | ELISA | Wantai ELISA Total‐Ab assay | RBD | Total ab | 1143/1215 | 94.1% | |
Gudbjartsson 2020 [C] | Community | ELISA | EDI/Eagle COVID‐19 IgG/IgM | N‐based | IgG | 539/1134 | 47.5% | |
Harritshoej 2021 [A] | Community | ELISA | Wantai ELISA Total‐Ab assay | RBD | Total ab | 120/123 | 97.6% | 16.6 |
Harritshoej 2021 [B] | Community | CLIA | Ortho Clinical VITROS Anti‐SARS‐Cov‐2 | S‐based | IgG | 118/123 | 95.9% | |
Harritshoej 2021 [C] | Community | CLIA | Siemens Atellica Total‐Ab assay | RBD | Total ab | 117/121 | 96.7% | |
Harritshoej 2021 [D] | Community | CLIA | Roche ‐ Elecsys anti‐SARS‐CoV‐2 Ab | N‐based | Total ab | 118/123 | 95.9% | |
Harritshoej 2021 [E] | Community | CLIA | YHLO SARS‐CoV‐2 iFlash IgG/IgM assay | N‐ and S‐based | IgG | 118/123 | 95.9% | |
Harritshoej 2021 [F] | Community | CLIA | Abbott Architect anti‐SARS‐CoV‐2 IgG | N‐based | IgG | 115/123 | 93.5% | |
Harritshoej 2021 [G] | Community | CLIA | Abbott Alinity anti‐SARS‐CoV‐2 IgG | N‐based | IgG | 115/123 | 93.5% | |
Harritshoej 2021 [H] | Community | ELISA | EUROIMMUN ‐ anti‐SARS‐COV‐2 IgG | S1‐based | IgG | 102/123 | 82.9% | |
Harritshoej 2021 [I] | Community | CLIA | Snibe Diagnostic ‐ MAGLUMI 2019‐nCoV | N‐ and S‐based | IgG | 101/122 | 82.8% | |
Harritshoej 2021 [J] | Community | CLIA | Diasorin ‐ LIAISON SARS‐CoV‐2 | S‐based | IgG | 110/123 | 89.4% | |
Harritshoej 2021 [L] | Community | CLIA | Ortho Clinical VITROS Anti‐SARS‐Cov‐2 | S1‐based | Total ab | 120/123 | 97.6% | |
Harritshoej 2021 [M] | Community | CLIA | Siemens Vista Total‐Ab assay | RBD | Total ab | 94/116 | 81.0% | |
Horber 2020 [A] | Hospital inpatient | CLIA | Siemens Atellica Total‐Ab assay | RBD | Total ab | 128/132 | 97.0% | 7.6 |
Horber 2020 [B] | Hospital inpatient | CLIA | Roche ‐ Elecsys anti‐SARS‐CoV‐2 Ab | N‐based | Total ab | 118/132 | 89.4% | |
Horber 2020 [C] | Hospital inpatient | ELISA | EUROIMMUN ‐ anti‐SARS‐COV‐2 IgG | S1‐based | IgG | 126/132 | 95.5% | |
Kaltenbach 2020 [B] | Community | ELISA | EUROIMMUN ‐ anti‐SARS‐COV‐2 IgG | S1‐based | IgG | 226/239 | 94.6% | 5.1 |
Kaltenbach 2020 [C] | Community | ELISA | Epitope Diagnostics ‐ EDI nCov COVID‐19 | N‐based | IgG | 214/239 | 89.5% | |
Korte 2021 [A] | Unclear | ELISA | EUROIMMUN ‐ anti‐SARS‐COV‐2 IgG | S1‐based | IgG | 132/141 | 93.6% | 7.8 |
Korte 2021 [C] | Unclear | ELISA | Epitope Diagnostics ‐ EDI nCov COVID‐19 | N‐based | IgG | 121/141 | 85.8% | |
MacMullan 2020 [B] | Unclear | ELISA | Gold Standard SARS‐CoV‐2 IgG ELISA | N‐based | IgG | 85/123 | 69.1% | 21.1 |
MacMullan 2020 [D] | Unclear | ELISA | EUROIMMUN ‐ anti‐SARS‐COV‐2 IgG | S1‐based | IgG | 111/123 | 90.2% | |
NSAE 2020 [A] | Hospital inpatient | CLIA | Abbott Architect anti‐SARS‐CoV‐2 IgG | N‐based | IgG | 458/490 | 93.5% | 4.9 |
NSAE 2020 [B] | Hospital inpatient | CLIA | Diasorin ‐ LIAISON SARS‐CoV‐2 | S‐based | IgG | 468/490 | 95.5% | |
NSAE 2020 [C] | Hospital inpatient | CLIA | Roche ‐ Elecsys anti‐SARS‐CoV‐2 Ab | N‐based | Total Ab | 481/490 | 98.2% | |
NSAE 2020 [D] | Hospital inpatient | CLIA | Siemens Atellica Total‐Ab assay | RBD | Total Ab | 482/490 | 98.4% | |
Patel 2021 [A] | Community | ELISA | EUROIMMUN ‐ anti‐SARS‐COV‐2 IgG | S1‐based | IgG | 127/146 | 87.0% | 17.5 |
Patel 2021 [B] | Community | ELISA | Epitope Diagnostics ‐ EDI nCov COVID‐19 | N‐based | IgG | 115/146 | 78.8% | |
Patel 2021 [C] | Community | ELISA | ImmunoDiagnostics SARS‐CoV‐2 IgG | N‐based | IgG | 107/140 | 76.4% | |
Patel 2021 [D] | Community | CLIA | Abbott Architect anti‐SARS‐CoV‐2 IgG | N‐based | IgG | 135/146 | 92.5% | |
Patel 2021 [E] | Community | CLIA | Roche ‐ Elecsys anti‐SARS‐CoV‐2 Ab | N‐based | Total ab | 201/214 | 93.9% | |
Weidner 2020 [A] | Community | ELISA | EUROIMMUN ‐ anti‐SARS‐COV‐2 IgG | N‐based | IgG | 179/197 | 90.9% | 10.0 |
Weidner 2020 [B] | Community | ELISA | Wantai ELISA Total‐Ab assay | RBD | Total ab | 98/100 | 98.0% | |
Weidner 2020 [C] | Community | CLIA | Roche ‐ Elecsys anti‐SARS‐CoV‐2 Ab | N‐based | Total ab | 94/99 | 94.9% | |
Weidner 2020 [D] | Community | CLIA | Diasorin ‐ LIAISON SARS‐CoV‐2 | S‐based | IgG | 88/100 | 88.0% |
Ab: antibody CGIA: colloidal gold immunoassay CLIA: chemiluminescent immunoassay D+: number of positive cases included in the analysis ELISA: enzyme‐linked immunosorbent assay TP: true positive aIn principle the cut‐off for inclusion was evaluation in at least 100 samples, however, to allow inclusion of as many studies with direct test comparisons as possible, we reported studies reporting evaluation in 98 samples or more.