TABLE 3.
LumiraDx SARS-CoV-2 Ag Test Performance in Cycle Threshold Subsets as Determined by the cobas 6800 SARS-CoV-2 Test (Roche Diagnostics), TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific), and Either Reverse Transcription–Polymerase Chain Reaction Method
| RT-PCR Test | Roche Diagnostics + Thermo Fisher Scientific | Roche Diagnostics | Thermo Fisher Scientific | |||
|---|---|---|---|---|---|---|
| Ct Value | No. | PPA (95% CI), % | No. | PPA (95% CI), % | No. | PPA (95% CI), % |
| <33 | 24 | 95.8 (79.8-99.3) | 8 | 100 (67.6-100) | 16 | 93.8 (71.7-98.9) |
| <30 | 22 | 100 (85.1-100) | 7 | 100 (64.6-100) | 15 | 100 (79.6-100) |
| <25 | 18 | 100 (82.4-100) | 6 | 100 (61.0-100) | 12 | 100 (75.8-100) |
CI, confidence interval; COVID-19, coronavirus disease 2019; Ct, cycle threshold; PPA; positive percent agreement; RT-PCR, reverse transcription–polymerase chain reaction; SARS-CoV-2, severe acute respiratory syndrome coronavirus 2.