SureSwab® Advanced Bacterial Vaginosis (BV), CT/NG, TMA

Test Code

10123

CPT Codes
87491, 87591, 81513

Includes

SureSwab® Advanced Bacterial Vaginosis (BV), TMA
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital

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)

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 • Samples with excess mucus • Specimens submitted in Aptima® tubes w/pierced foil lids • Swab submitted in viral transport media • Specimen in broken containers • Specimens in leaking containers

Methodology
Transcription Mediated Amplification (TMA)

Setup Schedule

Set up: Daily; Report available: 2-3 days

Clinical Significance

The assay is intended to aid in the diagnosis of Bacterial vaginosis (BV), and Chlamydia trachomatis/ Neisseria gonorrhoeae using clinician-collected and patient-collected vaginal swab specimens from individuals with a clinical presentation consistent with vaginitis and/or vaginosis.
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 Chlamydia trachomatis and Neisseria gonorrhoeae, a target capture assay is utilized for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae.

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.