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• This test does not differentiate between viable and non-viable organisms.
• This test does not differentiate between individuals that are carriers and individuals that
have an acute infection.
• Patients with vaginitis/vaginosis symptoms may have mixed infections. Therefore a
test indicating the presence of T. vaginalis does not rule out the presence of Candida
vulvovaginitis or Bacterial vaginosis.
• A negative result may be obtained if the specimen collection is inadequate or if antigen
concentration is below the sensitivity of the test. A negative OSOM Trichomonas Rapid
Test result may warrant additional patient follow up.
• Women with vaginal discharge should be evaluated for risk factors of cervicitis and
pelvic inammatory disease and for other organisms including Neisseria gonorroeae and
Chlamydia trachomatis.
• Samples contaminated with preparations containing iodine or by the immediate prior use
of vaginal lubricants are not recommended.
• Staphylococcus aureus in specimens at concentrations higher than 1x10
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organisms
per mL may interfere with the test results in negative samples. These concentrations of
S. aureus are higher than would be expected to be present in normal patient samples
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.
PERFORMANCE CHARACTERISTICS
Vaginal samples were collected from a total of 449 consenting adult patients presenting
to one of seven adult health centers. The specimens were tested for Trichomonas by wet
mount microscopy, culture (InPouch™ TV BioMed Diagnostics, Inc., San Jose, CA) and the
OSOM Trichomonas Rapid Test.
Diagnostic Sensitivity and Specicity – Versus Wet Mount Microscopy Standard Analysis
The performance of the OSOM
Trichomonas Rapid Test was determined using the accepted
calculations for comparative sensitivity and specicity against the results from wet mount
microscopy
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. The results from this analysis (with 95% condence intervals in parenthesis) are
summarized in Table 1.
Table 1 COMPARISON OF OSOM TRICHOMONAS RAPID TEST TO
WET MOUNT MICROSCOPY
Sensitivity: 69/72 = 96% (95% CI, 91-100%)
Specicity: 345/365 = 95% (95% CI, 92-97%)
Agreement: 414/437 = 95% (95% CI, 93-97%)
* Of the 20 samples negative by wet mount 16 were positive by culture - 4 were
negative.
Diagnostic Sensitivity and Specicity – Composite Reference Standard Analysis
The relative insensitivity of wet mount microscopy versus culture has been reported in the
literature
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. Therefore, the performance of the OSOM Trichomonas Rapid Test was analyzed
using a composite reference standard (CRS)
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calculation, which includes the results from wet
mount microscopy and culture (InPouch™ TV, BioMed Diagnostics, Inc., San Jose, CA). In
this analysis, any sample with a positive result from either wet mount or culture was dened
as positive. Accordingly, samples that were negative in both wet mount and culture tests were
dened as negative. The results of the comparison of the OSOM Trichomonas Rapid Test
using a standard vaginal swab sample to the CRS are shown in Table 2; 95% condence
intervals in parenthesis.
The results of the comparison of the OSOM Trichomonas Rapid Test using the saline remaining
from a wet mount sample are shown in Table 3. The comparative sensitivity of each method
to the CRS is shown in Table 4.
Wet Mount Microscopy
+ - total
OSOM Trichomonas Rapid Test
(vaginal swab)
+ 69 20* 89
- 3 345 348
total 72 365 437