Table 5.
Distribution of composite PCR scores by BV status
| Sample set | Assaya | BV status | No. with composite PCR score: |
||||||
|---|---|---|---|---|---|---|---|---|---|
| 0 | 1 | 2 | 3 | 4 | 5 | 6 | |||
| Development phase (n = 169) | qPCR | Negative (61) | 46 | 6 | 5 | 1 | 3 | 0 | 0 |
| Positive (108) | 3 | 4 | 3 | 11 | 29 | 32 | 26 | ||
| BV-PCR | Negative (61) | 46 | 9 | 3 | 2 | 1 | 0 | 0 | |
| Positive (108) | 3 | 3 | 4 | 17 | 25 | 29 | 27 | ||
| Validation phase (n = 169) | BV-PCR | Negative (117) | 82 | 16 | 9 | 3 | 6 | 1 | 0 |
| Positive (110) | 0 | 1 | 5 | 8 | 29 | 25 | 42 | ||
| Total (n = 396) | BV-PCR | Negative (178) | 128 | 25 | 12 | 5 | 7 | 1 | 0 |
| Positive (218) | 3 | 4 | 9 | 25 | 54 | 54 | 69 | ||
a
qPCR consisted of individual quantitative determinations of analyte concentrations; scores were determined by comparison of qPCR values with breakpoint concentrations established from frequency distributions of the development phase sample cohort. BV PCR is a semiquantitative assay using internal calibrators to assign individual analyte scores.