SureSwab® Advanced Bacterial Vaginosis (BV), TMA

Message
APTIMA SWAB (NO URINE)


Test Code
10016


Alias/See Also
LAB01159
Panther Back-up testing


CPT Codes
81513

Preferred Specimen
1 vaginal swab collected in Aptima® Multitest Transport tube


Minimum Volume
1 swab


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


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


Methodology
Transcription Mediated Amplification (TMA)

Setup Schedule
Daily


Report Available
2-4 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, 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
Quest Diagnostics Nichols Institute-San Juan Capistrano, CA
33608 Ortega Highway
San Juan Capistrano, CA 92675-2042




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.