SureSwab® Advanced Candida Vaginitis (CV)/Trichomonas vaginalis (TV), TMA : 10029

Test Code
CVTV or 10029


CPT Codes
87481x2, 87661

Includes
1. Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) 2. Candida glabrata 3. Trichomonas vaginalis


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).
Age restrictions may apply.
See individual tests for further information.


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 females 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-cvtv-assay


Methodology
Transcription-Mediated Amplification (TMA)

Setup Schedule
Monday - Saturday


Report Available
1-3 days


Reference Range
NOT DETECTED 


Clinical Significance
This test is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay utilizes real time transcription-mediated amplification (TMA) to detect and qualitatively report results for the following organisms: 1. Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) 2. Candida glabrata 3. Trichomonas vaginalis. The assay is intended to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis on using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis or vulvovaginitis.


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.