TABLE 7.
Codetection type | No. of codetections (% of samples) | No. of discrepant codetections | No. of discrepant organism ARG(s)a |
---|---|---|---|
Total | 103 (11.1%) | 34 | 39 |
Double detections | 84 (9.0%) | 22 | 22 |
Triple detections | 19 (2.0%) | 12 | 17 |
A discrepant organism/ARG is one that was detected by the BCID-GN panel but not by the comparator method(s) (i.e., false positive); 36/39 false-positive organisms were investigated using PCR/sequencing (3 Pan GP organisms were not tested). Of the 36 false-positive organisms tested, 32 were detected, 3 were not detected, and 1 was indeterminate.
Refer to the 510k summary (Tables 60 and 61) for more detail (10).