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5
Table 2 COMPARISON OF OSOM TRICHOMONAS RAPID TEST TO
COMPOSITE REFERENCE STANDARD
Sensitivity: 85/102 = 83% (95% CI, 76-91%)
Specicity: 331/335 = 99% (95% CI, 98-100%)
Agreement: 416/437 = 95% (95% CI, 93-97%)
* Of the 20 samples negative by wet mount 16 were positive by culture - 4 were negative.
Table 3 COMPARISON OF OSOM TRICHOMONAS RAPID TEST SALINE FROM WET
MOUNT SAMPLE TO COMPOSITE REFERENCE STANDARD
Sensitivity: 79/105 = 75% (95% CI, 67-84%)
Specicity: 337/342 = 99% (95% CI, 97-100%)
Agreement: 416/447 = 93% (95% CI, 91-95%)
Table 4 SENSITIVITY OF EACH METHOD VERSUS COMPOSITE
REFERENCE STANDARD
Method Sensitivity
OSOM Trichomonas Rapid Test (vaginal swab) 83%
OSOM Trichomonas Rapid Test (saline from wet mount) 75%
Wet Mount Microscopy 71%
Culture (InPouch™ TV) 99%
POL Studies
An evaluation of the OSOM Trichomonas Rapid Test was conducted at four physician
ofces. Each site tested a randomly coded panel of negative (6), low positive (3), and high
positive samples (3). Three operators at each site ran all 12 samples, which produced the
following results:
Sample Agreement
Negative 100% (95% CI, 95-100%)
Low 97% (95% CI, 85-100%)
High 100% (95% CI, 90-100%)
Assay Reproducibility
Intra-assay and inter-assay reproducibility studies demonstrated 100% agreement with
expected results. Testing was performed by two operators, on three lots of OSOM Trichomonas
Rapid Test kits, using laboratory preparations of high positive, low positive and negative T.
vaginalis samples. For intra-assay reproducibility each sample was tested twenty times within
one run. For inter-assay reproducibility samples were tested in duplicate, two runs per day, over
ve consecutive days.
Composite reference standard
+ - total
OSOM Trichomonas Rapid Test
(vaginal swab)
+ 85 4* 89
- 17 331 348
total 102 335 437
Composite reference standard
+ - total
OSOM Trichomonas Rapid Test
(saline from wet mount)
+ 79 5 84
- 26 337 363
total 105 342 447