Product Manual

TABLE 1. RESULTS OF A STUDY OF 113 WOMEN
Patient Type Mean Vaginal Fluid Sialidase Activity
Patients with BV (n=28) 12.3 U (95% CI 8.1 – 16.6 U)
Healthy Controls (n=65) 2.7 U (95% CI 2.2 – 3.2 U)
Patients with Candidiasis (n=17) 3.7 U (95% CI 2.6 – 4.8 U)
Patients with Trichomoniasis (n=3) 1.99 U (95% CI 0.6 – 3.4 U)
PERFORMANCE CHARACTERISTICS:
MINIMUM DETECTION LIMIT (MDL):
The OSOM BVBLUE Test was evaluated by different users using control samples to demonstrate the MDL
of 0.25 µg (7.64 U). A total of 72 samples with sialidase levels above the MDL were evaluated. Complete
agreement of results was obtained on every sample. A total of 141 samples with sialidase levels below
the MDL were evaluated. Complete agreement of results was obtained on every of samples.
REPRODUCIBILITY STUDIES:
The OSOM BVBLUE Test was evaluated at three clinics by three different users (MLTs and RNs) for
reproducibility within and between runs and clinics. Each site evaluated 5 coded control samples
in triplicate on each of 3 days. A total of 45 samples were evaluated by each clinic. Three of the 5
samples were positive samples and 2 were negative samples. Complete agreement of results was
obtained on every sample by each of the three sites, demonstrating the inter-operator, inter-site,
intra-site, and inter-day reproducibility of the test.
The OSOM BVBLUE Test was evaluated at three clinics by three different users (MLTs and RNs) for
reproducibility within and between runs and clinics. Each site evaluated 10 coded clinical samples
over 3 days. Six of the 10 samples were positive samples and 4 were negative samples. Complete
agreement of results was obtained on every sample by each of the three sites, demonstrating the
inter-operator, inter-site, intra-site, and inter-day reproducibility of the test.
INTERFERENCE STUDIES:
In all clinical studies, no evidence of interference was observed for menses (n=118); blood (n=620);
semen (n= 620); birth control methods (n=36) including birth control pills, Depo-Provera, Norplant,
IUDs, condoms, or tubal ligation; or microorganisms (n=118) including Staphylococcus, Streptococcus,
E. coli, Candida albicans, Lactobacillus, among others.
METHOD COMPARISON:
The OSOM BVBLUE Test was evaluated at five clinics by different users (MDs, MLTs, and RNs) in the US.
A total of 620 women were evaluated. Patients treated with a vaginal cream or ointment product
within 72 hours prior to testing were excluded.
Independent investigators evaluated the performance of the OSOM BVBLUE Test compared to Amsel
Criteria in 620 women (TABLE 2). A clinical diagnosis of BV required the following three symptoms:
vaginal fluid pH > 4.5, the presence of vaginal fluid amines, and the presence of clue cells (>20%).
Of the 164 symptomatic women, 65% were diagnosed with BV. Of the 456 asymptomatic women,
<1% were diagnosed with BV. The sensitivity and specificity of OSOM BVBLUE compared to Amsel
Criteria was found to be 85.2% and 89.6% respectively.
Independent investigators evaluated the performance of OSOM BVBLUE compared to Gram’s stain
in 118 women (TABLES 3 and 5). A clinical diagnosis of BV required a Gram’s stain score of 7–10.
(16)
Of the 27 symptomatic women, 78% were diagnosed with BV. Of the 91 asymptomatic women,
11% were diagnosed with BV. The sensitivity and specificity of OSOM BVBLUE compared to Gram’s
stain was found to be 90.3% and 96.6% respectively.
Independent investigators evaluated the performance of OSOM BVBLUE compared to Gram’s stain
in 220 women (TABLE 6). The sensitivity and specificity of OSOM BVBLUE compared to Gram’s stain
was found to be 92.8% and 98.0%, respectively.
TABLE 3. UNRECONCILED PERFORMANCE OF
OSOM BVBLUE COMPARED TO GRAM’S STAIN.
TABLE 2. UNRECONCILED PERFORMANCE OF
OSOM BVBLUE COMPARED TO AMSEL CRITERIA
BVBLUE
Positive
All patients tested (n = 620)
(P < 0.0001)
145
(23.4%)
Results in patients with
BV by Amsel Criteria (n = 108)
92
(85.2%)
Results in patients without
BV by Amsel Criteria (n = 512)
53
(10.4%)
BVBLUE
Positive
All patients tested (n = 118)
(P < 0.0001)
31
(26.3%)
Results in patients with
BV by Gram’s Stain (n = 31)
28
(90.3%)
Results in patients without
BV by Gram’s Stain (n = 87)
3
(3.4%)