Bacterial Vaginosis (Aptima® BV Assay) -IVD

TEST:   CPT: 87801

Storage Instructions

Causes for Rejection

Use

Limitations

Methodology

CDC INFO

Expected Turnaround Time 1-4 days

Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the report is sent to the ordering provider.  Additional time should be allowed for confirmatory, or reflex tests. 

Additional Documentation

SPECIMEN COLLECTION GUIDE

Specimen Requirements

Specimen

Vaginal swab

Collection

Click on the images for a color guide

Multitest Vaginal Swab: 

Care provider specimen: Collect vaginal fluid sample using the Gen-Probe® Aptima® Vaginal Swab Kit by contacting the swab to the lower third of the vaginal wall, rotating the swab for 10 to 30 seconds to absorb the 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. 

Patient self-collection instructions: Partially open the package. 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® Vaginal Swab Specimen Collection Kit. Remove the swab. Carefully insert the swab into the vagina about 2" past the introitus and gently rotate the swab for 10 to 30 seconds, making sure the swab touches the walls of the vagina so that moisture is absorbed by the swab. Withdraw the swab without touching the skin. 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.

Store and transport specimens at room temperature (15 to 30°C). DO NOT freeze.

Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; specimens received after prolonged delay from time of pickup (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® swab transport >30 days from collection; Aptima® swab specimens with incorrect specimen volume; Aptima® swab specimen without a swab; any non−Aptima® swab submitted in Aptima® transport device; wooden-shaft swab in transport device; transport device with multiple swabs; female urethral swab; bloody or grossly mucoid specimens; bacterial swabs; specimen in MDL OneSwab®, ProbeTec™ UPT transport; ProbeTec™ Q-swabs; UTM-RT

Test Details

The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. 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 on the automated Panther® system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.

The performance of the assay has not been evaluated in adolescents less than 14 years of age.

A negative result does not preclude a possible infection because results are dependent on adequate specimen collection. Test results may be affected by improper specimen collection, technical error, specimen mix-up, or target levels below the assay limit of detection (LoD).

Performance with specimen types other than vaginal swab specimens has not been evaluated.

See Product insert for full list of limitations.

Nucleic acid amplification (NAAT)

CDC Treatment resources:

Multitest Swab in female

Treatment and testing information:

BV CDC information: https://www.cdc.gov/std/tg2015/bv.htm