Bacterial Vaginosis, NAA
Use
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.
Special Instructions
Not provided.
Limitations
This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. Ensure specimens are not submitted with incorrect patient identification, or in inappropriate conditions including being frozen, in expired transport devices, or with a fixative.
Methodology
PCR-based (semiquantitative PCR)
Biomarkers
Atopobium vaginae
MicroorganismBVAB-2
MicroorganismMegasphaera-1
Microorganism
LOINC Codes
- 69565-0 - A vaginae DNA Vag Ql NAA+probe
- 69566-8 - BVAB2 DNA Vag Ql NAA+probe
- 69567-6 - Mega1 DNA Vag Ql NAA+probe
Result Turnaround Time
3-4 days
Related Documents
For more information, please review the documents below
Specimen
Vaginal Swab
Volume
One swab
Minimum Volume
One swab
Container
Aptima® Multitest Swab Specimen Collection Kit or Aptima® Unisex Swab Specimen Collection Kit
Collection Instructions
Collect vaginal fluid sample using the 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.
Storage Instructions
Maintain specimen at room temperature or refrigerate (2°C to 30°C).
Causes for Rejection
Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions, including specimens received frozen; specimens received after prolonged delay (usually >72 hours); specimen leaked in transit; specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima® urine transport; Aptima® swab transport >30 days from collection; Aptima® swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima® swab transport; any non-Aptima® swab submitted in Aptima® transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec™ UPT transport; ProbeTec™ Q-swabs
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 30 days |
| Refrigerated | 30 days |
| Frozen | Not acceptable |
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