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Correlation of interpretive results generated from BV PCR assay analysis of study samples with consensus gold standard results
| Sample set | BV status | No. with BV PCR result: |
||
|---|---|---|---|---|
| Positive | Negative | Indeterminate | ||
| Development phase (n = 169) | Positive | 98 | 6 | 4 |
| Negative | 3 | 55 | 3 | |
| Validation phase (n = 227) | Positive | 104 | 1 | 5 |
| Negative | 10 | 98 | 9 | |
| Total (n = 396) | Positive | 202 | 7 | 9 |
| Negative | 13 | 153 | 12 | |
