Table 1.
Assay (instrument) | Samples | Comparator method | NPA, PPA, and TA‡ | Additional studies performed | References |
---|---|---|---|---|---|
Semi-quantitativea (autoanalyzer) | 33 pos. 78 neg. | Diagnostic RT-PCR |
NPA: 100.0% PPA: 97.0% TA: 99.1% |
Sensitivity, robustness, imprecision, stability, interferences, and other studies | This work |
Semi-quantitativea (autoanalyzer) | 34 pos.† 75 neg.† | Diagnostic RT-PCR |
NPA: 97.3% PPA: 97.1% TA: 97.2% |
Sensitivity, robustness, imprecision, stability, interferences, and other studies | This work |
Semi-quantitativea (autoanalyzer) | 52 pos. 11 neg. | Diagnostic RT-PCR |
NPA: 88.5% PPA: 100% TA: 90.5% |
None | 16 |
Qualitativeb (autoanalyzer) | 18 pos. 177 neg. | Venous plasma antibody measurements |
NPA: 88.8%% PPA: 100% TA: 99.0% |
Sample quality assessment only | 15 |
Qualitativeb (autoanalyzer) | 373 pos. 1337 neg. | Venous plasma antibody measurements |
NPA: 99.2% PPA: 98.7% TA: 98.8% |
None | 20 |
Qualitativec (plate reader) | 108 pos. 281 neg.* | Venous serum antibody measurements |
NPA: 98.1% PPA: 98.6% TA: 98.5% |
Sample quality assessment only | 19 |
Qualitatived (plate reader) | 111 pos. 278 neg.* | Venous serum antibody measurements |
NPA: 94.7% PPA: 98.9% TA: 97.7% |
Sample quality assessment only | 19 |
Qualitativec (plate reader) | 35 pos.† 30 neg.† | Diagnostic RT-PCR |
NPA: 82.8% PPA: 76.7% TA: 80.0% |
Stability, robustness, imprecision, and other studies | 17 |
Qualitativec (plate reader) | 22 pos. 21 neg. | Diagnostic RT-PCR |
NPA: 90.9% PPA: 100% TA: 95.3% |
Stability, robustness, imprecision, and other studies | 10 |
Qualitativee (plate reader) | 22 pos. 21 neg. | Diagnostic RT-PCR |
NPA: 86.4% PPA: 95.2% TA: 90.7% |
Stability, robustness, imprecision, and other studies | 10 |
Qualitativef (flow cytometer) | 51 pos. 108 neg. | Venous serum antibody measurements |
NPA: 98.0% PPA: 100% TA: 99.4% |
Imprecision | 18 |
*Borderline measurements were treated as negative for ease of method comparison.
†DBS samples were self-collected by the patient.
‡Total agreement.
aRoche Elecsys Anti-SARS-CoV-2 S immunoassay.
bRoche Elecsys anti-SARS-CoV-2 immunoassay.
cEuroimmun anti-SARS-CoV-2 IgG ELISA.
dEuroimmun anti-SARS-CoV-2 NCP IgG ELISA.
eEpitope Diagnostics Novel Coronavirus COVID-19 IgG ELISA kit.
fLuminex xMAP SARS-CoV-2 multi-antigen assay.