Summary
- Over the course of 2020, more than 400 COVID-19/ SARS-CoV-2 tests have been released to the market, many with scant regulatory review e.g. via FDA/EUA of CE Self-certification (IVDD).
- To date, 46 of these tests have been independently, publically and reliably reviewed (e.g. CDC, FINDdx…)
- One out of four (26%) SARS-2/Covid-19 test on the market is less reliable than a coin toss i.e. their Positive Predictive Value is lower than 50%, based on these independent reviews.
Commentary:
The use of some low-specificity Rapid-Diagnostic-Tests results in a significant number of False-Positive results, triggering potentially unnecessary or heavy-handed Public Health interventions.
For example: Santa Clara (USA/CA, a local study reported 14% SARS2 prevalence i.e. 50 times the PCR-based prevalence (Published in Nature)
Knowledge is key to curb this pandemic!
Methodology:
Abbreviations:
SARS-CoV-2 | Manufacturer | Test | Format | Sensitivity | Prevalence | Low | High | ||
5% | 15% | ||||||||
Specificity | PPV low prev. | NPV high prev. | PPV low prev. | NPV high prev. | |||||
Antibodies | Euroimmun | SARS-COV-2 ELISA (IgG) | Lab | 90.0% | 100.0% | 100.0% | 99.5% | 100.0% | 98.3% |
Antibodies | Mikrogen | recomWell SARS-CoV-2 IgG | Lab | 86.4% | 100.0% | 100.0% | 99.3% | 100.0% | 97.7% |
Antibodies | Mount Sinai | COVID-19 ELISA Antibody Test | Lab | 92.5% | 100.0% | 100.0% | 99.6% | 100.0% | 98.7% |
Antibodies | Ortho | Anti-SARS-CoV-2 IgG test | Lab | 90.0% | 100.0% | 100.0% | 99.5% | 100.0% | 98.3% |
Antibodies | Viramed | SARS-CoV-2 Virachip IgG | Lab | 77.3% | 100.0% | 100.0% | 98.8% | 100.0% | 96.1% |
Antibodies | Roche | Elecsys Anti-SARS-CoV-2 | Lab | 100.0% | 99.8% | 96.3% | 100.0% | 98.9% | 100.0% |
Antibodies | Abbott | Architect SARS-CoV-2 IgG | Lab | 100.0% | 99.6% | 92.9% | 100.0% | 97.8% | 100.0% |
Antibodies | Bio-Rad | Platelia SARS-CoV-2 Total Ab | Lab | 92.2% | 99.6% | 92.4% | 99.6% | 97.6% | 98.6% |
Antibodies | DiaSorin | LIAISON SARS-CoV-2 S1/S2 IgG | Lab | 97.6% | 99.3% | 88.0% | 99.9% | 96.1% | 99.6% |
Antibodies | Abbott | Alinity i SARS-CoV-2 IgG | Lab | 100.0% | 99.0% | 84.0% | 100.0% | 94.6% | 100.0% |
Antibodies | CDC | SARS-CoV-2 | Lab | 96.0% | 99.0% | 83.5% | 99.8% | 94.4% | 99.3% |
Antibodies | Wadsworth | SARS-CoV Microsphere Immunoassay for Antibody Detection | Lab | 88.0% | 98.8% | 79.4% | 99.4% | 92.8% | 97.9% |
Antibodies | EuroImmun | IgA Elisa | Lab | 90.0% | 93.0% | 40.4% | 99.4% | 69.4% | 98.1% |
Antibodies | EDI | COVID-19 IgG | Lab | 100.0% | 88.7% | 31.8% | 100.0% | 61.0% | 100.0% |
Antibodies | EpitopeElisa | Lab | 81.0% | 89.8% | 29.5% | 98.9% | 58.3% | 96.4% | |
Antibodies | Sure-Bio | POCT | 71.4% | 100.0% | 100.0% | 98.5% | 100.0% | 95.2% | |
Antibodies | Wantai | Total Ab Elisa | POCT | 93.0% | 100.0% | 100.0% | 99.6% | 100.0% | 98.8% |
Antibodies | AutoBio Diagnostics | Anti-SARS-CoV-2 Rapid Test | POCT | 99.0% | 99.0% | 83.9% | 99.9% | 94.6% | 99.8% |
Antibodies | Wondfo | POCT | 81.0% | 99.1% | 82.6% | 99.0% | 94.1% | 96.7% | |
Antibodies | UCP Biosciencs | POCT | 71.4% | 98.1% | 66.4% | 98.5% | 86.9% | 95.1% | |
Antibodies | Premier | POCT | 81.0% | 97.2% | 60.3% | 99.0% | 83.6% | 96.7% | |
Antibodies | Cellex | qSARS-CoV-2 IgG/IgM Rapid Test | POCT | 93.8% | 96.0% | 55.2% | 99.7% | 80.5% | 98.9% |
Antibodies | Innovita | POCT | 64.3% | 96.3% | 47.8% | 98.1% | 75.4% | 93.9% | |
Antibodies | Bioperfectus | POCT | 81.0% | 95.2% | 47.0% | 99.0% | 74.8% | 96.6% | |
Antibodies | Chembio | DPP Covid-19 IgM/IgG System | POCT | 93.5% | 94.4% | 46.8% | 99.6% | 74.7% | 98.8% |
Antibodies | VivaDiag | POCT | 71.4% | 94.9% | 42.4% | 98.4% | 71.2% | 95.0% | |
Antibodies | DecomBio | POCT | 70.0% | 89.7% | 26.3% | 98.3% | 54.5% | 94.4% | |
Antibodies | Lumos | FebriDx | POCT | 93.0% | 86.0% | 25.9% | 99.6% | 54.0% | 98.6% |
Antibodies | Biomedomics | POCT | 81.0% | 86.9% | 24.5% | 98.9% | 52.2% | 96.3% | |
Antibodies | DeepBlue | POCT | 81.0% | 84.3% | 21.3% | 98.8% | 47.6% | 96.2% | |
Antigen | Abbott | BINAXNOW™ COVID-19 Ag CARD | POCT | 93.3% | 99.9% | 98.0% | 99.6% | 99.4% | 98.8% |
Antigen | Abbott | PANBIO™ COVID-19 Ag RAPID TEST | POCT | 86.2% | 99.9% | 97.8% | 99.3% | 99.3% | 97.6% |
Antigen | BioNote | Biocredit One Step SARSCoV-2 Antigen | POCT | 63.2% | 99.5% | 86.4% | 98.1% | 95.5% | 93.9% |
Antigen | Coris | Standard Q COVID-19 Ag | POCT | 84.8% | 98.9% | 79.7% | 99.2% | 93.0% | 97.4% |
Antigen | Rapigen | NowCheck COVID-19 Antigen Test | POCT | 89.2% | 97.3% | 63.5% | 99.4% | 85.4% | 98.1% |
Antigen | Roche(SD Biosensor) | COVID-19 Ag Respi-Strip | POCT | 50.0% | 95.8% | 38.5% | 97.3% | 67.8% | 91.6% |
RNA | bioMérieux SA | BioFire COVID-19 Test | Lab | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
RNA | bioMérieux SA | SARS-COV-2 R-GENE® (ref 423717) | Lab | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
RNA | DiaSorin Molecular, LLC | Simplexa? COVID-19 Direct RT-PCR Kit | Lab | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
RNA | Hologic | Panther Fusion SARS-CoV-2 assay | Lab | 94.1% | 100.0% | 100.0% | 99.7% | 100.0% | 99.0% |
RNA | Roche Ltd | Coronavirus LightMix® Modular SARS and Wuhan CoV E-gene assay | Lab | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
RNA | Roche Molecular Diagnostics | cobas® SARS-CoV-2 (for use on the cobas® 6800/8800 Systems) | Lab | 96.2% | 100.0% | 100.0% | 99.8% | 100.0% | 99.3% |
RNA | Thermo Fisher Scientific | TaqMan? 2019-nCoV Assay Kit v1 | Lab | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% | 100.0% |
RNA | Thermo Fisher Scientific | TaqPath COVID-19 Combo Kit | Lab | 93.8% | 100.0% | 100.0% | 99.7% | 100.0% | 98.9% |
RNA | Abbott Diagnostics Inc. | ID NOW COVID-19 | POCT | 87.7% | 100.0% | 100.0% | 99.4% | 100.0% | 97.9% |
RNA | Cepheid | Xpert Xpress SARS-CoV-2 | POCT | 99.4% | 100.0% | 100.0% | 100.0% | 100.0% | 99.9% |