SureSwab® Advanced Vaginitis, TMA

Test Code
10119


CPT Codes
81513, 87481 (x2), 87661

Includes
SureSwab® Advanced Bacterial Vaginosis (BV), TMA
SureSwab® Advanced Candida Vaginitis (CV), TMA
Trichomonas vaginalis (TV), TMA


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 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
Set up: Daily; Report available: Next day


Reference Range
SureSwab® Adv Bacterial Vaginosis (BV), TMA Negative
Candida species Not detected
Candida glabrata Not detected
Trichomonas vaginalis (TV), TMA Not detected


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.




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.