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. 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. • 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. • 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. 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.
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. 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 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 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 of the Internal Quality Controls does not produce expected results. 2. External Quality Controls External Controls 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 may be purchased separately from Sekisui Diagnostics, 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 If the controls still do not perform as expected, contact Sekisui Diagnostics Technical Service at 1-800-332-1042. You should follow the manufacturer’s guidelines for QC testing. These guidelines state that external controls be run with each new lot, each new shipment and with each new untrained operator.
Rev. 3763-10, 03/15