Table 1.
Comparison of FVU-UWCC with GSUS test performance for the prediction of either Chlamydia trachomatis or Mycoplasma genitalium infection using training set samples
| Test organism | Sensitivity | p Value* | Specificity | p Value* | Positive predictive value | Negative predictive value | ||||
|---|---|---|---|---|---|---|---|---|---|---|
| UWCC† | GSUS‡ | UWCC† | GSUS‡ | UWCC† | GSUS‡ | UWCC† | GSUS‡ | |||
| C. trachomatis | 93.7% (67.7% to 99.6%) |
93.7% (67.7% to 99.6%) |
1 | N/A | N/A | 28.3% (17.1% to 42.5%) |
16.1% (9.6% to 25.5%) |
99.3% (95.8% to 99.9%) |
99.1% (94.5% to 99.9%) |
|
| M. genitalium | 72.7% (49.5% to 88.3%) |
81.8% (58.9% to 94%) |
0.72 | N/A | N/A | 29% (18% to 43%) |
19.3% (12.1% to 29.1%) |
96% (91.2% to 98.3%) |
96.5% (90.8% to 98.8%) |
|
|
C. trachomatis or M. genitalium |
81.5% (65.1% to 91.6%) |
86.8% (71.1% to 95%) |
0.75 | 85.8% (79.5% to 90.4%) |
64.7% (56.9 to 71.7%) |
<0.001 | 56.3% (42.3% to 69.4%) |
35.4% (26% to 46.1%) |
95.4% (90.4% to 97.9%) |
95.6% (89.6% to 98.3%) |
*p Values represent the results of statistical comparisons of either sensitivity or specificity between the two test methodologies. These were generated using McNemar’s test for paired binary data with the results of C. trachomatis NAAT testing upon BD Viper System or real-time PCR for M. genitalium as the reference standards.
†UWCC were defined as positive if the patient’s urine contained >29 White blood cell per µL.
‡GSUS testing containing >5 PMN per high power fields (HPFs) over 5 HPFs was examined.
FVU, first void urine; GSUS, Gram-stained urethral smear; NAAT, nucleic acid amplification testing; UWCC, urinary white cell counts.