TABLE 3.
Agreement of cobas for M. genitalium with each NAAT
| Test or statistic | No. with NAAT1 test result of: |
Total | No. with NAAT2 test result of: |
Total | No. with NAAT3 test result of: |
Total | |||
|---|---|---|---|---|---|---|---|---|---|
| M. genitalium positivea | M. genitalium-negative NAAT1 | M. genitalium positiveb | M. genitalium negative | M. genitalium positivec | M. genitalium-negative NAAT3 | ||||
| Vaginal swabs | |||||||||
| M. genitalium positive | 36 | 52 | 88 | 55 | 33 | 88 | 88 | 0 | 88 |
| M. genitalium negative | 13 | 999 | 1,012 | 10 | 1,002 | 1,012 | 26 | 986 | 1,012 |
| Total | 49 | 1,051 | 1,100 | 65 | 1,035 | 1,100 | 114 | 986 | 1,100 |
| PPA (% [95% CI]) | 73.5 (59.7–83.8) | 84.6 (73.9–91.4) | 77.2 (68.7–83.9) | ||||||
| NPA (% [95% CI]) | 95.1 (93.6–96.2% | 96.8 (95.6–97.7) | 100 (99.6–100) | ||||||
| OPA (% [95% CI])d | 94.1 (92.5–95.3) | 96.1 (94.8–97.1) | 97.6 (96.6–98.4) | ||||||
| Male urine samples | |||||||||
| M. genitalium positive | 57 | 27 | 84 | 52 | 32 | 84 | 79 | 5 | 84 |
| M. genitalium negative | 12 | 943 | 955 | 5 | 950 | 955 | 3 | 952 | 955 |
| Total | 69 | 970 | 1,039 | 57 | 982 | 1,039 | 82 | 957 | 1,039 |
| PPA (% [95% CI]) | 82.6 (72.0–89.8) | 91.2 (81.1–96.2) | 96.3 (89.8–98.7) | ||||||
| NPA (% [95% CI]) | 97.2 (96.0–98.1) | 96.7 (95.4–97.7) | 99.5 (98.8–99.8) | ||||||
| OPA (% [95% CI]) | 96.2 (94.9–97.2) | 96.4 (95.1–97.4) | 99.2 (98.5–99.6) | ||||||
a
NAAT1 represents LDT 1 (targets the mgbA gene).
b
NAAT2 represents LDT 2 (targets 23S rRNA).
c
NAAT3 represents LDT3 (targets 16S rRNA).
d
OPA, overall percentage agreement.