Product Manual

For facilities in the US: A CLIA Certificate of Waiver is needed to perform testing in waived settings. Read
all instructions carefully before use. If a laboratory modifies the following test instructions including Quality
Control, the test will be considered High Complexity and no longer considered Waived.
INTENDED USE:
The OSOM BVBLUE Test is an enzyme activity test for use in the detection of vaginal fluid specimens
for sialidase activity, an enzyme produced by bacterial pathogens such as Gardnerella vaginalis,
Bacteroides spp., Prevotella spp., and Mobiluncus spp.
The OSOM BVBLUE Test is indicated for use in women suspected of having Bacterial Vaginosis (BV) infection,
e.g., women with vaginal discharge typical of BV and/or women with previous history of BV, as an aid
in the diagnosis of BV infection. Test results should be considered in conjunction with other clinical and
patient information (see Limitations of the Procedure).
For in vitro Diagnostic Use Only. The OSOM BVBLUE Test is indicated for professional use only and may be
used at the point of care and/or in physician’s offices. It is not intended for home use.
SUMMARY AND EXPLANATION OF THE TEST:
Vaginitis is one of the most common reasons that women visit obstetricians or gynecologists.
(1 – 3)
BV is the
most common form of infectious vaginitis. The causative agents of the infection are bacterial pathogens
such as Gardnerella vaginalis, Bacteroides spp., Prevotella spp. and Mobiluncus spp.
Complications associated with BV include salpingitis, endometritis, post-hysterectomy infections, recurrent
UTI’s, and an increased risk of PID and HIV.
(5 – 7)
BV presents a serious danger in women, due to its significant
association with placental infection, premature rupture of membranes, and preterm birth.
(8 –10)
Studies have shown elevated sialidase activity in women with BV and an increased risk for preterm
birth and low birth weight infants in patients exhibiting elevated sialidase activity.
(4, 11 – 15)
The OSOM BVBLUE Test is designed to provide a clear, simple indication of elevated sialidase activity
in patient vaginal fluid samples. The generation of a blue or green color indicates a positive test result;
a yellow color indicates a negative test result.
PRINCIPLES OF BVBLUE:
The OSOM BVBLUE Test includes a chromogenic substrate of bacterial sialidase. In the test procedure,
a vaginal fluid sample is placed in the BV Test Vessel. The sample then reacts with the chromogenic
substrate. A Developer Solution is added after the reaction.
If the sample has a high level of sialidase, a blue or green color will be seen in the BV Test Vessel or on
the head of the swab. If the sample has no sialidase, or has very low levels, a yellow color will be seen
in the BV Test Vessel.
REAGENTS / MATERIALS:
• IBX-4041 component (0.25 mg/test)
• potassium acetate (24.5 mg/test)
• sodium hydroxide (1.0 mg/test)
MATERIALS PROVIDED:
• 25 Test Vessels each containing 0.25 mg IBX-4041 component in 0.5 mL of an aqueous
potassium acetate buffer solution (49mg/mL; 0.5 M; pH 5.5-6.0)
• 1 Developer Solution Bottle containing 10.0 mL of an aqueous sodium hydroxide solution
(40mg/mL; 1.0 M; pH>11.0)
• Sterile Swabs
• 1 Directional Insert
MATERIALS REQUIRED BUT NOT PROVIDED:
• OSOM BVBLUE Control Kit
• Timer
®
CLIA Complexity: Waived
BVBLUE
®
Test