TABLE 4.
Probit analysis of serial 10-fold dilution experiments using Treponema pallidum whole cell and in vitro 23S rRNA transcripts as challenges to determine RUO T. pallidum TMA limit of detection
| Matrix | Challenge | Limit of detection value (%) | Result (lower limit, upper limit) | McFadden R2 coefficient |
|---|---|---|---|---|
| Specimen transport medium | T. pallidum whole cell | 50 | 5 (3–8) cells/mL | 0.911 |
| 95 | 48 (24–143) cells/mL | 0.911 | ||
| T. pallidum 23S rRNA in vitro transcript | 50 | 221 (124–396) copies/mL | 0.927 | |
| 95 | 5,707 (2,454–21,111) copies/mL | 0.927 | ||
| Rectal swab matrix | T. pallidum whole cell | 50 | 3 (2, 5) cells/mL | 0.985 |
| 95 | 9 (6, 16) cells/mL | 0.985 | ||
| T. pallidum 23S rRNA in vitro transcript | 50 | 316 (none given) copies/mL | 1 | |
| 95 | 421 (none given) copies/mL | 1 |