Test Details
Methodology
Nucleic acid amplification (NAA)
Result Turnaround Time
3 - 4 days
Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.
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.
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.
Specimen Requirements
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
Vaginal swab: 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.
Stability Requirements
Temperature | Period |
|---|---|
Room temperature | 30 days |
Refrigerated | 30 days |
Frozen | Not acceptable |
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
LOINC® Map
| Order Code | Order Code Name | Order Loinc | Result Code | Result Code Name | UofM | Result LOINC |
|---|---|---|---|---|---|---|
| 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 | |
| Order Code | 180060 | |||||
| Order Code Name | Bacterial Vaginosis, NAA | |||||
| Order Loinc | ||||||
| Result Code | 180061 | |||||
| Result Code Name | Atopobium vaginae | |||||
| UofM | Score | |||||
| Result LOINC | 69565-0 | |||||
| Order Code | 180060 | |||||
| Order Code Name | Bacterial Vaginosis, NAA | |||||
| Order Loinc | ||||||
| Result Code | 180062 | |||||
| Result Code Name | BVAB 2 | |||||
| UofM | Score | |||||
| Result LOINC | 69566-8 | |||||
| Order Code | 180060 | |||||
| Order Code Name | Bacterial Vaginosis, NAA | |||||
| Order Loinc | ||||||
| Result Code | 180063 | |||||
| Result Code Name | Megasphaera 1 | |||||
| UofM | Score | |||||
| Result LOINC | 69567-6 |