Table 1.
Results for clinical evaluations of ID NOW COVID-19 assay
| Retrospective clinical evaluation | Days since symptom onseta |
|
|---|---|---|
| 1–21 days (median 3) | 1–7 days (median 2) | |
| Number of positive casesb | 21 | 14 |
| Number of negative casesc | 316 | 314 |
| Number of positive SARS-CoV-2 samples by SOC RT-PCR | 19 | 13 |
| Ct range of positive SARS-CoV-2 samples by SOC RT-PCR | 17.1–37.3 | 17.1–31.8 |
| Number of positive SARS-CoV-2 samples by ID NOW | 17 | 11 |
| Number of false-positive SARS-CoV-2 samples by ID NOW | 1 | 1 |
| Number of negative SARS-CoV-2 samples by SOC RT-PCR | 318 | 316 |
| Number of negative SARS-CoV-2 samples by ID NOW | 320 | 317 |
| Number of false-negative SARS-CoV-2 samples by ID NOW |
3 |
2 |
| Prospective hospital pilot sites |
Monash |
Austin |
| Staff using test, n | 6 | 16 |
| Total participants, n | 634 | 410 |
| Excluded, n | 0 | 1 |
| Total included, N | 634 | 409 |
| Median age, years (range) | 35 (8–83) | 36 (4–90) |
| Male gender, n (%) | 290 (45.7%) | 167 (40.8%) |
| Asymptomatic, n (%) | 48 (7.6%) | 7 (1.7%) |
| Median days of symptoms (range) | 2 (1–60) | 1 (0–14) |
| Positive RT-PCR result, n (%) | 0 (0%) | 0 (0%) |
| Positive Abbott ID NOW result, n (%) | 1 (0.2%) | 0 (0%) |
a
Where known for symptomatic cases. Individuals who were 1–7 days since symptom onset are a subset of the group of individuals who are 1–21 days since symptom onset.
b
Individuals with known COVID-19 infection notified to Department of Health and Human Services (DHHS): only 19 of 21 of these individuals were RT-PCR positive at the time of recruitment to this study.
c
Individuals who tested negative for SARS-CoV-2 and were not considered COVID-19 cases by DHHS at the time.