Test Overview
The Aptima BV assay is a real time TMA assay developed for use on the automated Panther system that detects and discriminates RNA markers from the Lactobacillus species group (L. gasseri, L. crispatus and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae in clinician-collected and patient-collected vaginal swab specimens from symptomatic females. The Aptima BV assay uses an algorithm to report a qualitative result for BV based on detection of target organisms.
This assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection of organisms associated with bacterial vaginosis (BV). The assay reports a qualitative result for BV and does not report results for individual organisms. The assay is intended to aid in the diagnosis of BV from clinician-collected or patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.
Negative
* Reference ranges may change over time. Please refer to the original patient report when evaluating results.
The effects of other potential variables such as vaginal discharge, use of tampons, and specimen collection variables have not been determined. Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results. Therapeutic failure or success cannot be determined with the Aptima BV assay since nucleic acid may persist following appropriate antimicrobial therapy. A positive result should be interpreted in conjunction with other clinical data available to the clinician. A negative result does not preclude a possible infection. Test results may be affected by improper specimen collection, technical error, or specimen mix-up. Performance of the assay has not been evaluated in individuals less than 14 years of age. The Aptima BV assay has not been evaluated for use with specimens collected by patients at home. Collection and testing of patient-collected vaginal swab specimens with the Aptima BV assay is not intended to replace clinical examination.
Test Details
Specimens received Sunday-Thursday 1-day TAT
Specimens received Friday or Saturday 2-3 days TAT
- MBVSC
- MBV
- BV
- Bacterial Vaginosis
- Patient collect BV
- Self collect BV
Specimen Requirements
Instructions for vaginal swab specimen collection:
1. Partially peel open the swab package (Aptima multitest swab specimen collection kit).
Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
3. Carefully insert the swab into the vagina about 2 inches (5 cm) past the introitus and gently rotate the swab clockwise for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab and then withdraw the swab without touching the skin.
4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen Collection Kit.
5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
6. Carefully break the swab shaft at the score line against the side of the tube.
7. Immediately discard the top portion of the swab shaft.
8. Tightly screw the cap onto the tube.