10. Sensitivity and specificity by brand (IgG, IgG or IgM, total Ab).
|
Target antibody Method |
Test brand | Test name | Antigen |
95% CI > 90%a (Yes/No) |
Convalescent N evaluations (N samples) |
Sensitivity (%, 95% CI) | 95%CI > 96%b |
Pre‐pandemic N evaluations (N samples) |
Specificity (%, 95% CI)c |
| IgG alone | |||||||||
| CLIA | Autobio Diagnostics | SARS‐CoV‐2 CLIA Microparticles IgM/IgG | S | Y | 1 (271/273) | 99.3(97.4, 99.9) | N | no data | |
| LFA | Qingdao HIGHTOP | SARS‐CoV‐2 IgG/IgM Ab Rapid Test | N, S | Y | 1 (216/229) | 94.3 (90.5, 96.9) | N | 1 (149/150) | 99.3 (96.3, 100) |
| LFA | Sure Biotech | SARS‐CoV‐2 IgG/IgM Antibody Rapid Test | N, S | Y | 2 (226/235) | 96.2 (92.8, 98.0) | N | 2 (370/378) | 98.7 (87.2, 99.9) |
| CLIA | Abbott Diagnostics | Abbott Architect anti‐SARS‐CoV‐2 nucleocapsid IgG/IgM | N | Y | 33 (1824/1977) | 92.5 (90.3, 94.3) | Y | 24 (7460/7483) | 99.7 (99.5, 99.8) |
| CLIA | Shenzhen YHLO Biotech | YHLO iFlash IgG/IgM assay | N, S | Y | 5 (260/268) | 97.0 (94.1, 98.5) | Y | 2 (657/661) | 99.4 (98.4, 99.8) |
| LFA | Augurix SA | SimtomaX Corona Check IgG | N, S | N | 1 (124/220) | 56.4 (49.5, 63.0) | Y | 1 (267/268) | 99.6 (97.9, 100) |
| LFA | bioMerieux | Vidas SARS‐CoV‐2 IgG | S (RBD) | N | 2 (101/107) | 94.4 (88.1, 97.5) | Y | 2 (1084/1085) | 99.9 (99.3, 100) |
| LFA | Biopanda | COVID‐19 Rapid Ab test | N, S | N | 1 (102/163) | 62.6 (54.7, 70.0) | Y | 1 (499/500) | 99.8 (98.9, 1.00) |
| LFA | Dynamiker Biotechnology | 2019‐nCOV IgG Rapid Test | N | < 100 | 1 (72/75) | 96.0(88.8, 99.2) | Y | 1 (395/403) | 98.0(96.1, 99.1) |
| LFA | Fortress Diagnostics | COVID‐19 Total Ab | S | N | 1 (258/307) | 84.0 (79.5, 88.0) | Y | 1 (493/500) | 98.6 (97.1, 99.4) |
| LFA | SD Biosensor | COVID‐19 IgG Duo | N | < 100 | 4 (50/69) | 74.2 (52.1, 88.3) | Y | 4 (1125/1127) | 99.8 (96.2, 100) |
| ELISA | Beijing Wantai | ELISA IgG assay | S | < 100 | 2 (57/58) | 98.3 (90.8, 99.9) | Y | 1 (195/197) | 99.0(96.4, 99.9) |
| ELISA | Eagle Biosciences | COVID‐19 IgG Quantitative ELISA | N | N | 1 (539/1134) | 47.5 (44.6, 50.5) | Y | 1 (429/437) | 98.2 (96.4, 99.2) |
| ELISA | Epitope Diagnostics | EDI nCov COVID‐19 IgM ELISA kit | N | N | 13 (780/934) | 87.7 (78.1, 93.4) | Y | 13 (2892/3014) | 98.0 (96.2, 99.0) |
| ELISA | EUROIMMUN | anti‐SARS‐COV‐2 IgG ELISA | S (S1) | N | 41 (2200/2442) | 90.8 (88.6, 92.7) | Y | 29 (4998/5144) | 98.4 (97.5, 98.9) |
| CLIA | Abbott Diagnostics | Abbott Alinity anti‐SARS‐CoV‐2 nucleocapsid IgG | N | N | 2 (149/163) | 91.3 (83.8, 95.5) | Y | 2 (636/640) | 99.4 (98.3, 99.8) |
| CLIA | Beckman Coulter | Beckman Coulter ‐ Access SARS‐CoV‐2 IgG | S (RBD) | < 100 | 2 (78/94) | 92.4 (38.8, 99.6) | Y | 1 (396/399) | 99.2(97.8, 99.8) |
| CLIA | DiaSorin | LIAISON SARS‐CoV‐2 S1/S1 IgG CLIA | S | N | 21 (1523/1735) | 88.1 (84.1, 91.2) | Y | 16 (4290/4367) | 98.6 (97.8, 99.1) |
| CLIA | Ortho Clinical Diagnostics | VITROS Anti‐SARS‐Cov‐2 Total assay IgG | S (S1) | N | 3 (201/221) | 92.3 (80.8, 97.1) | Y | 3 (1139/1141) | 99.8(99.3, 100) |
| CLIA | SNIBE | MAGLUMI 2019‐nCoV IgG kits | N, S | N | 7 (325/369) | 89.9 (83.3, 94.1) | Y | 7 (1801/1818) | 99.1 (98.5, 99.4) |
| Other | ET Healthcare | Pylon 3D automated immunoassay system IgG | N, S | < 100 | 2 (37/37) | 100(90.5, 100) | Y | 1 (316/320) | 98.8(96.8, 99.7) |
| IgG or IgM | |||||||||
| LFA | SureScreen Diagnostics | COVID‐19 Coronavirus Rapid Test Cassette IgG/IgM | S | Y | 3 (248/257) | 96.5 (93.4, 98.2) | Y | 2 (497/500) | 99.4 (98.2, 99.8) |
| LFA | Guangzhou Wondfo | SARS‐CoV‐2 Antibody Test | S | N | 6 (211/265) | 85.1 (69.0, 93.6) | Y | 4 (1644/1648) | 99.8 (98.8, 100) |
| LFA | SD Biosensor | COVID‐19 IgG Duo | N | < 100 | 1 (6/7) | 85.7(42.1, 99.6) | Y | 1 (933/942) | 99.0(98.2, 99.6) |
| LFA | NG Biotech | NG‐Test IgG COVID‐19 | N | N | no data | Y | 2 (274/276) | 99.3 (97.2, 99.8) | |
| ELISA | Epitope Diagnostics Inc. | EDI nCov COVID‐19 IgM ELISA kit | N | < 100 | 2 (42/50) | 84.0 (71.1, 91.8) | Y | 4 (1159/1184) | 97.9 (96.9, 98.6) |
| Total Ab | |||||||||
| ELISA | Beijing Wantai | ELISA Total‐Ab assay | S (RBD) | Y | 8 (1562/1649) | 95.7 (92.6, 97.5) | Y | 8 (2009/2020) | 99.5 (99.0, 99.7) |
| CLIA | Ortho Clinical Diagnostics | VITROS anti‐SARS‐Cov‐2 Total assay | S (S1) | Y | 2 (192/200) | 96.0 (92.2, 98.0) | Y | 2 (995/997) | 99.8 (98.5, 100) |
| CLIA | Roche Diagnostics | Elecsys anti‐SARS‐CoV‐2 antibody assay | N | Y | 34 (3669/3916) | 93.4 (91.1, 95.1) | Y | 25 (5569/5579) | 99.8 (99.7, 99.9) |
| CLIA | Siemens Healthcare | Siemens Atellica Total‐Ab assay | S (RBD) | Y | 7 (979/1009) | 96.7 (94.2 98.1) | Y | 6 (2435/2439) | 99.9 (99.3, 100) |
| CLIA | Xiamen InnoDx | 2019‐nCoV antibody test kit Total‐Ab | S (RBD) | < 100 | 1 (37/38) | 97.4(86.2, 99.9) | Y | 1 (267/270) | 98.9(96.8, 99.8) |
| CLIA | Siemens Healthcare | Siemens Vista Total‐Ab assay | S (RBD) | N | 1 (94/116) | 81.0 (72.7, 87.7) | Y | 1 (596/596) | 100 (99.4, 100) |
| Other | Luminex | SARS‐CoV‐2 MIA Total Ab | N | < 100 | 1 (19/19) | 100(82.4, 100) | Y | 1 (254/256) | 99.2(97.2, 99.9) |
| a pre‐set criteria for sensitivity were assay evaluation in ≥ 200 samples and lower bound of 95% CI for sensitivity was 90% or higher b pre‐set criteria for specificity were assay evaluation in ≥ 200 samples, point estimate for specificity ≥ 98% and lower bound of 95% CI was 96% or higher c sensitivity and specificity estimates per brand are not necessarily paired estimates from the same set of studies (i.e. were not calculated from the same meta‐analytic model) but were calculated separately using univariate analyses such that there may be differences in the set of studies contributing to sensitivity and to specificity for any given test brand (although there will be overlap between them). | |||||||||
CI: confidence interval CGIA: colloidal gold immunoassay CLIA: chemiluminescent immunoassay ELISA: enzyme linked immunosorbent assay FIA: fluorescence immunoassay LFA: lateral flow assay N: nucleocapsid antigen RBD: receptor binding domain RT‐PCR: reverse transcription polymerase chain reaction S: soluble antigen