Product Manual

If the controls still do not perform as expected contact Sekisui Diagnostics Technical Service at
1-800-332-1042.
2a. For CLIA Waived Labs
You should follow the guidelines below for QC testing. The manufacturer recommends that external
controls be run with each new lot, each new shipment and with each new untrained operator.
2b. For CLIA Non-Waived Labs
Quality Control requirements should be established in accordance with local, state and federal
regulations or accreditation requirements. Minimally, the manufacturer recommends that external
controls be run with each new lot, each new shipment and with each new untrained operator.
LIMITATIONS OF THE PROCEDURE:
• Do not use samples from the cervix.
• Patients may have mixed infections. The OSOM BVBLUE Test shows that sialidase enzyme is active
in the sample. The OSOM BVBLUE Test does not show if other organisms such as yeast and parasitic
organisms are present in the sample.
• Test results should be considered in conjunction with other clinical and patient information.
• Test operators must follow all instructions to a) collect the sample, b) store the sample, and
c)use the test procedure properly. If the instructions are not followed, the OSOM BVBLUE test
may not give correct results.
EXPECTED VALUES:
The OSOM BVBLUE Test can show sialidase activity in vaginal fluid at levels of ≥7.64U. There are two
possible results; positive or negative. If the test fails to provide a blue, green, or yellow color result,
the test is invalid.
INSTRUCTIONS FOR USE:
Allow the kit to come to room temperature before running the test.
STEP 1
Remove one BV Test Vessel and the Developer Solution
Bottle from the kit prior to use. Remove the cap from the
BV Test Vessel.
STEP 2
Collect a vaginal fluid sample with a swab. Contact
the swab with the lower one-third of the vaginal wall.
Collect as much fluid as possible.
NOTE: Do not use samples from patients who have used
vaginal cream products within 72 hours before testing.
Do not touch or collect fluid near the cervix.
STEP 3
Put the swab into the BV Test Vessel. Gently swirl the mixture.
STEP 4
Let the BV Test Vessel containing the swab stand
for 10 minutes between 17˚ and 37˚C, (62.6˚ – 98.6˚F).
STEP 5
Add one drop of Developer Solution to the BV Test
Vessel containing the swab. Gently swirl the mixture.
Read the results immediately.
CAUTION: The Developer Solution is a dilute alkaline solution.
This may cause skin and eye irritation. If the solution comes in
contact with the skin or eyes, flush with large volumes of water.
INTERPRETATION OF TEST RESULTS:
There are two possible results: (a) positive result or
(b) negative result.
a) Positive Result: A blue or green color in the BV
Test Vessel or on the head of the swab.
b) Negative Result: A yellow color in the BV Test Vessel.
NOTE: You may need to remove the swab to read the
test results.
A Positive Result shows a high level of sialidase activity.
A Negative Result shows a normal level of sialidase activity.
10 min
17° – 37°C
(62 .6° – 98.6°F )
NEGATIVEPOSITIVE