TABLE 1.
Culture detects GBS in fewer samples than any of three FDA-cleared molecular testsa
| Test | Result | No. of culture results before (after) analysis of discordant results |
Total | |
|---|---|---|---|---|
| Positive | Negative | |||
| GeneOhm | Positive | 48 (48) | 24 (21) | 72 (69) |
| Negative | 0 (0) | 241 (244) | 241 (244) | |
| MAX | Positive | 48 (48) | 24 (20) | 72 (68) |
| Negative | 0 (0) | 241 (245) | 241 (245) | |
| illumigene | Positive | 48 (48) | 19 (20) | 67 (68) |
| Negative | 0 (0) | 246 (245) | 246 (245) | |
| Total | 48 | 265 | 313 | |
a
Data represent detection of GBS by culture compared to detection by three FDA-cleared molecular tests for 313 antepartum vaginal/anal swabs before and after (in parentheses) analysis of discordant results. The first valid result is reported. For culture versus MAX, agreement = 93.3%, κ = 0.79. For culture versus illumigene, agreement = 93.6%, κ = 0.79. For culture versus GeneOhm, agreement = 93.0%, κ = 0.78.