SureSwab® Advanced Vaginitis Plus, TMA

Test Code

10120

CPT Codes
81513, 87481 (x2), 87661, 87491, 87591

Includes

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

FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

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
C. trachomatis RNA, TMA, Urogenital	Not detected
N. gonorrhoeae RNA, TMA, Urogenital	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, as well as Chlamydia trachomatis and Neisseria gonorrhoeae is 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.
For Chlamydia trachomatis and Neisseria gonorrhoeae, A target capture assay for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae is utilized.

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.