TABLE 5.
Results of N. gonorrhoeae testing by the Combo 2 assay versus infection status in all patients (n = 1,484)
| Specimen type and symptomatic status | n | No. of patients who were:
|
Sensitivitya | Specificitya | PPV (%) | NPV (%) | |||
|---|---|---|---|---|---|---|---|---|---|
| Infected
|
Not infected
|
||||||||
| Combo 2 positive | Combo 2 negative | Combo 2 positive | Combo 2 negative | ||||||
| Swab | |||||||||
| Symptomatic | 881b | 94 | 0 | 15c | 772 | 100 (96.2-100) | 98.1 (96.9-98.9) | 86.2 | 100 |
| Asymptomatic | 596d | 31 | 1 | 2e | 562 | 96.9 (83.8-99.9) | 99.6 (98.7-100) | 93.9 | 99.8 |
| Unknown | 2 | 1 | 0 | 0 | 1 | NCf | NC | NC | |
| Total | 1,479 | 126 | 1 | 17 | 1,335 | 99.2 (95.7-100) | 98.7 (98.0-99.3) | 88.1 | 99.9 |
| FCU | |||||||||
| Symptomatic | 883 | 87 | 7 | 7g | 782 | 92.6 (85.3-97.0) | 99.1 (98.2-99.6) | 92.6 | 99.1 |
| Asymptomatic | 599 | 28 | 4 | 3h | 564 | 87.5 (71.0-96.5) | 99.5 (98.5-99.1) | 90.3 | 99.3 |
| Unknown | 2 | 1 | 0 | 0 | 1 | NC | NC | NC | |
| Total | 1,484 | 116 | 11 | 10 | 1,347 | 91.3 (85.0-95.6) | 99.3 (98.6-99.6) | 92.1 | 99.2 |
a
Values are percentages. Values in parentheses are 95% confidence intervals.
b
Does not include two patients for whom only FCU results were available.
c
All 15 specimens were available for confirmatory testing; 13 were positive.
d
Does not include three patients for whom only FCU results were available.
e
Both specimens were available for confirmatory testing; both were positive.
f
Not calculated.
g
All seven specimens were available for confirmatory testing; four were positive.
h
Of these three specimens, two were available for confirmatory testing; both were negative.