Product Manual

WARNINGS AND PRECAUTIONS:
• For in vitro diagnostic use only.
• Do not use after the expiration date printed on the kit.
• Do not store the kit at temperatures above 8°C (46°F).
• Do not store the kit in strong light.
• Follow your laboratory safety guidelines in the collection, handling, storage and disposal of patient
specimens and all items exposed to patient specimens.
• Used tests should never be re-used.
• This product is intended for vaginal fluid use only.
• Developer solution contains an sodium hydroxide solution. The use of nitrile or latex gloves, wearing
protective eye wear, and clothing is recommended when handling the reagent within this kit. Wash
hands thoroughly after handling material.
SPECIMEN COLLECTION AND STORAGE:
• Using a swab provided in the kit, collect specimens from the lower one-third of the vaginal wall.
Collecting specimens from the cervix should be avoided because (a) it might increase risk to OB
patients, and (b) cervical sialidase activity is usually higher than vaginal sialidase activity.
• Do not use specimens from patients who have (a) used a vaginal cream or ointment product,
(b) douched, or (c) used spermicides, vaginal lubricants or feminine sprays within 72 hours of testing.
• Test the patient specimen as soon as possible after collection.
• If you do not perform the OSOM BVBLUE test immediately, store the swabs either at room temperature
for up to 48 hours or refrigerated for up to 7 days. To transport patient specimens, place each swab
in a clean, dry container such as a plastic or glass tube. Do not use any transport media.
• If you do not collect enough sample or collect from a patient undergoing antimicrobial therapy
the test may give a false negative result.
STORAGE AND STABILITY:
Store the kit refrigerated, 2°-8°C (36°-46°F), out of direct sunlight. Store vessels inside
the box. Kit contents are stable until the expiration date printed on the outer box.
NOTE: Allow the kit to come to room temperature before running the test.
INDICATIONS OF INSTABILITY:
Signs of possible product instability include:
• A blue color in a BV Test Vessel when one drop of Developer Solution is added to the BV Test Vessel
in the absence of a patient specimen.
• Positive control does not give expected results.
• Negative control does not give expected results.
QUALITY CONTROL:
1. Internal Quality Controls
The OSOM BVBLUE Test contains two types of internal quality control with each test run. For daily quality
control, the manufacturer recommends documenting these controls on each day of testing:
• Type 1 Control: Before adding a patient specimen, inspect the BV Test Vessel. It should contain
a colorless liquid without precipitates (sediment).
If the testing vessel contains a precipitate, the test is invalid. Do not use the BV Test Vessel.
• Type 2 Control: The OSOM BVBLUE Test has a two-color result format: blue/green is positive, yellow
is negative. After running the test according to the instructions for use, the appearance of either
a uniform yellow, blue, or green color in the testing vessel or a blue or green color on the swab
assures proper mixing of the reagent and sample has occurred.
If the test fails to provide either a blue, green, or a yellow color result the test is invalid.
Do not report patient results if either the Type 1 Control or the Type 2 Control does not
produce expected results.
2. External Quality Controls
External Controls (available from Sekisui Diagnostics), are used to test that the reagents are working
properly. Also use the Controls to test that you are able to correctly perform the test procedure.
• A Control Kit that contains a positive control and a negative control is available from Sekisui
Diagnostics and may be purchased separately, Catalog No. 184.
• Refer to the Control Kit Directional Insert for instructions on how to interpret the results of the controls.
If QC testing fails:
• Check expiration dates of the test kit and controls
• Ensure the instructions for testing were followed
• Repeat the test