TABLE 3.
Summary of limit of detection results for Simplexa Congenital CMV Direct-saliva swab
| Positive rate (%)a |
Probit (±95% CI)a,b |
|||||||
|---|---|---|---|---|---|---|---|---|
| Strains | cp/mL in UTM (1 mL) | IU/mL in UTM (1 mL) | cp or IU/Rx | Percent detection (no. detected/no. tested) | Mean CT ± SD (% CV) | cp/mL in UTM (1 mL) | IU/mL in UTM (1 mL) | cp/Rx |
| AD-169 | 500 | NA | 5 | 100.0% (48/48) | 36.6 ± 0.9 (2.5%) | 274 ± 12 | NA | 3 |
| Towne | 500 | NA | 5 | 95.8% (46/48) | 36.5 ± 0.9 (2.6%) | 465 ± 12 | NA | 5 |
| Merlin | NA | 500 | 5 | 95.8% (46/48) | 37.7 ± 1.2 (3.3%) | NA | 480 ± 12 | 5 |
| Strains | cp/mL in UTM (3 mL) | IU/mL in UTM (3 mL) | cp or IU/Rx | Percent detection (no. detected/no. tested) | Mean CT ± SD (% CV) | cp/mL in UTM (3 mL) | IU/mL in UTM (3 mL) | cp/Rx |
| AD-169 | 500 | NA | 5 | 100.0% (48/48) | 36.0 ± 1.0 (2.8%) | 300 ± 14 | NA | 3 |
| Towne | 500 | NA | 5 | 100.0% (48/48) | 35.4 ± 1.6 (4.4%) | 346 ± 10 | NA | 3 |
| Merlin | NA | 500 | 5 | 100.0% (48/48) | 37.3 ± 1.0 (2.7%) | NA | 363 ± 14 | 4 |
| Strains | cp/mL in M4RT (3 mL) | IU/mL in M4RT (3 mL) | cp or IU/Rx | Percent detection (no. detected/no. tested) | Mean CT ± SD (% CV) | cp/mL in M4RT (3 mL) | IU/mL in M4RT (3 mL) | cp/Rx |
| AD-169 | 500 | NA | 5 | 100.0% (48/48) | 36.3 ± 0.7 (2.0%) | 360 ± 12 | NA | 4 |
| Towne | 500 | NA | 5 | 100.0% (48/48) | 35.4 ± 1.1 (3.0%) | 315 ± 12 | NA | 3 |
| Merlin | NA | 500 | 5 | 95.8% (46/48) | 37.3 ± 1.0 (2.7%) | NA | 352 ± 12 | 4 |
a
CI, confidence interval; cp, copies; IU, international units; NA, not applicable; Rx, reaction; SD, standard deviation; CV, coefficient of variation.
b
±, upper/lower 95%.