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This test is intended to be used as an aid to the diagnosis of bacterial vaginosis (BV) in women with a clinical presentation consistent with this disorder. The BV test utilizes semiquantitative PCR analysis of the three most predictive marker organisms (Atopobium vaginae, BVAB-2, and Megasphaera-1) to generate a total score that correlates directly with the presence or absence of BV. In this test system, samples with a total score of 0 to 1 are considered negative for BV, samples with a score of 3 to 6 are positive for BV, and samples with a score of 2 are indeterminate for BV.
This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.
Nucleic acid amplification (NAA)
Vaginal swab: Collect vaginal fluid sample using the Gen-Probe® Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap.
Causes for Rejection
|Order Code||Order Code Name||Order Loinc||Result Code||Result Code Name||UofM||Result LOINC|
|180060||Bacterial Vaginosis, NAA||180048||Bacterial Vaginosis, NAA||N/A|
|180060||Bacterial Vaginosis, NAA||180061||Atopobium vaginae||Score||69565-0|
|180060||Bacterial Vaginosis, NAA||180062||BVAB 2||Score||69566-8|
|180060||Bacterial Vaginosis, NAA||180063||Megasphaera 1||Score||69567-6|
|Reflex Table for Megasphaera 1|
|Order Code||Order Name||Result Code||Result Name||UofM||Result LOINC|
|Reflex 1||180046||Total Score, add three scores||180046||Total Score, add three scores||N/A|