SureSwab® Advanced Bacterial Vaginosis (BV), TMA : 10016

Test Code

BV or 10016

CPT Codes
81513

Includes

Bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L.crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae.

Preferred Specimen

1 vaginal swab collected in Aptima® Multitest Transport tube

Minimum Volume

1 swab

Transport Container

Vaginal swab: Follow instructions in the Aptima® Multitest Collection Kit (orange label).

Transport Temperature

Room temperature.

Specimen Stability

Swabs in Aptima® Transport:
Room temperature: 30 days; Refrigerated: 30 days; Frozen: 60 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

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 excess mucus; Specimens submitted in Aptima tubes with pierced foil lids; Specimens in broken containers; Specimens in leaking containers

Note: 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

Methodology
Transcription-Mediated Amplification (TMA)

Setup Schedule

Monday - Saturday

Report Available

1-3 days

Reference Range

NEGATIVE

Clinical Significance

This 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. The assay is intended to aid in the diagnosis of BV using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.

Performing Laboratory
med fusion

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.