Table 2. Nucleic acid amplification test platform discordant target results for SARS-CoV-2 obtained with the Canadian Laboratory Response Network’s SARS-CoV-2 Proficiency Test Panels, May 2020 to June 2021.
| PCR platform | Assay target | PCR platform SARS-CoV-2 discordant results (%) | Sensitivity: 95% detectiona,b (copies/ml) |
Specificity | |
|---|---|---|---|---|---|
| Positive agreement (%)b | Negative agreement (%)b | ||||
| BD SARS-CoV-2 Reagents for the BD MAXTM System | N1 | 6/96 (6.25%) | 1,100 or fewer | 100 | 100 |
| N2 | 7/96 (7.29%) | 1,100 or fewer | 100 | 100 | |
| BioFire® Film Array® RP2.1 | M/S | 1/414 (0.24%) | 1,100 or fewer | 100 | 100 |
| Cepheid Xpert® Xpress SARS-CoV-2 | E | 0/730 (0.00%) | 1,100 or fewer | 100 | 100 |
| N | 6/730 (0.82%) | 1,100 or fewer | 100 | 97 | |
| DiaSorin SimplexaTM COVID-19 Direct Molecular Assay | ORF1a/b | 3/768 (0.39%) | 1,100 or fewer | 99.7 | 100 |
| S | 4/768 (0.52%) | 1,100 or fewer | 99.6 | 100 | |
| NxTAG® Respiratory Pathogen Panel + SARS-CoV-2 | ORF1a/b | 0/12 (0.00%) | 1,100 or fewer | 100 | 100 |
| M | 1/12 (8.33%) | 1,100 or fewer | 100 | 100 | |
| RIDA® gene SARS-CoV-2 Test | E | 2/18 (11.11%) | 1,100 or fewer | 100 | 100 |
| Seegene AllplexTM 2019 nCoV Assay | E | 11/252 (4.37%) | 1,100 or fewer | 100 | 100 |
| RdRp | 14/252 (5.56%) | 1,358 | 99.1 | 100 | |
| N | 9/252 (3.57%) | 1,100 or fewer | 100 | 100 | |
Abbreviations: PCR, polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2
a Assessment using Sample C, G and P
b Off-label procedural methods and user errors were removed from the assessment