TABLE 4.
Summary of limit of detection results for Simplexa Congenital CMV Direct-urine
| Positive rate (%)a |
Probit (±95% CI)a,b |
|||||||
|---|---|---|---|---|---|---|---|---|
| Strains | cp/mL | IU/mL | cp/Rx | Percent detection (no. detected/no. tested) | Mean CT ± SD (% CV) | cp/mL | IU/mL | cp/Rx |
| AD-169 | 400 | NA | 4 | 100.0% (48/48) | 37.5 ± 1.3 (3.5%) | 350 ± 12 | NA | 4 |
| Towne | 800 | NA | 8 | 100.0% (48/48) | 35.7 ± 0.8 (2.3%) | 652 ± 11 | NA | 7 |
| Merlin | NA | 6,400 | 64 | 100.0% (48/48) | 35.4 ± 0.6 (1.8%) | NA | 3,997 ± 58 | 40 |
a
CI, confidence interval; cp, copies; IU, international units; NA, not applicable.
b
±, upper/lower 95%.