Bacterial Vaginosis (BV), Vaginitis, TMA
Test Code: 10119
CPT Code(s): 81513, 87481 (x2), 87661 *CPT coding may differ dependent on payer rules which may impact prior authorization testing. Please direct any questions regarding CPT coding to the payer being billed.
Clinical Significance: The assay is intended to aid in the diagnosis of vaginitis using clinician-collected and patient-collected vaginal swab specimens from individuals with a clinical presentation consistent with vaginitis. Testing for bacterial vaginosis (BV), vulvovaginal candidiasis and trichomoniasis are included.
The BV test 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.
For vulvovaginal candidiasis and trichomoniasis, a real time transcription-mediated amplification (TMA) assay is used to detect and qualitatively report results for Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), C. glabrata, and Trichomonas vaginalis.
Methodology: Transcription Mediated Amplification (TMA)
Alternative Name(s): Fishy odor discharge, Vulvovaginitis, Leukorrhea, Vaginitis, Vaginal itching, vaginal discharge
Supply: #A03 APTIMA® Vaginal (Multitest) Swab
Preferred specimen(s): 1 vaginal swab collected in Aptima® Multitest Transport Tube
Minimum volume: 1 swab
Collection instructions:
Follow instructions in the Aptima® Multitest collection kit (orange label)
Performance of the assay has not been evaluated in individuals less than 14 years of age.
For a complete list of assay limitations we recommend that you review the manufacturers package insert: https://www.hologic.com/package-inserts/diagnostic-products/aptima-bv-assay
Transport container: Aptima® Multitest Transport Tube
Transport temperature: Room temperature
Specimen Stability:
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 60 days
Rejection Criteria:
- Transport tube with no swab
- Transport tube with 2 swabs
- Transport tube containing cleaning swab
- Transport tube with non-Aptima swabs
- Transport tube submitted with swab inverted
- Swab submitted in viral transport media
- Samples with excessive mucus
- Specimens submitted in Aptima tubes with pierced foil lids
- Patients less than 14 years of age
For additional supply or collection device information, please contact DLO's Customer Services at (800) 891-2917, option 2.
*The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.