TABLE 2.
Metric | Value | % | |
---|---|---|---|
No. of pooled tests run | 39,297 | 100 | |
No. of negative poolsb | 38,593 | 98.2 | |
No. of positive poolsc | 310 | 0.8 | |
No. of invalid poolsd | 31 | 0.1 | |
No. of inconclusive poolse | 67 | 0.2 | |
Unsatisfactory specimens (test not performed) | |||
Reason: at least one swab upside down in tube | 215 | 0.6 | |
Reason: lab incident | 46 | 0.1 | |
Reason: sample received >56 h after collectionf | 26 | 0.1 | |
Reason: sample too viscous after rehydration | 3 | 0.01 | |
Reason: tube label data do not match order | 2 | 0.01 | |
Positive pool viral N1 target CT, mean (SD) | 26.4 (5.6) | ||
Positive pool viral N1 target CT, range | 15.3–37.8 | ||
Positive pool viral N2 target CT, mean (SD) | 27.9 (6.3) | ||
Positive pool viral N2 target CT, range | 15.7–39.8 |
Results are based on a RT-PCR with multiplexed N1, N2, and RP targets as outlined in the assay EUA (EUA200147). CT, cycle threshold.
Negative pools have no detected viral targets and a positive human control target (RP gene).
Positive pools have two detected viral targets (N1 and N2).
Invalid pools have no detected viral targets and no detected human control target.
Inconclusive pools have only one viral target detected.
Acceptable specimens for testing must be received at the laboratory within 56 h of collection based on FDA stability studies.