Product Manual

MIXED INFECTIONS:
The OSOM BVBLUE Test was investigated in 255 patients stratified by clinical diagnosis.
The results of this study are presented in TABLE 4.
TABLE 4. RESULTS OF OSOM BVBLUE IN PATIENTS STRATIFIED BY CLINICAL DIAGNOSES
No. of Patients
Clinical Diagnosis
BVBLUE
Amsel Criteria Wet Mount
BV Yeast Trich Positive
5 + + – 4
2 + – + 2
4 – – + 0
41 – + – 0
50 + – – 48
153 – – – 9
Total (255) 57 46 6 63
TABLE 5. PERFORMANCE OF OSOM BVBLUE AND EIGHT OTHER CLINICAL
METHODS COMPARED TO GRAM’S STAIN RESULTS IN 118 PATIENTS.
Test vs.
Gram’s Stain
Sensitivity
(%)
Specificity
(%)
Overall Accuracy
(%)
All patients (n=118)
OSOM BVBLUE 90.3 96.6 94.9
Amsel Criteria 58.1 95.4 85.6
Vaginal Fluid pH
a
(n =117 ) 90.3 6 5.1 71.8
Vaginal Fluid Amines (n=117) 67.7 93.0 86.3
Vaginal Fluid pH and Vaginal Fluid Amines
b
(n =117 )
67.7 94.2 87. 2
Wet Prep (>20% clue cells)
(n =117 )
71.0 89.5 84.6
Wet Prep (any clue cells)
(n =117 )
77.4 84.9 82.9
Semiquantitative Identification of Morphotypes
Asociated with BV
c
100 86.2 89.8
Clinically Significant Culture of Microorganisms
Associated with BV
d
(n=55)
55.6 86.5 76.4
a
Vaginal fluid pH > 4.5 considered positive result.
b
Vaginal fluid pH > 4.5 and presence of vaginal fluid amines considered positive result. All other
combinations considered negative result.
c
Includes identification and scoring of Gardnerella vaginalis, Bacteroides spp., Prevotella spp.,
and/or Mobiluncus spp. using Gram’s stain. Score of 1+ considered positive result for Mobiluncus
spp. All other morphotypes required score of 3+.
d
Includes typing and scoring of Gardnerella vaginalis, Bacteroides spp., and/or Prevotella spp.
Score of 2+ for each microorganism considered positive result.