SureSwab® Advanced Candida Vaginitis (CV), TMA : 10121

Test Code

CV or 10121

CPT Codes
87481x2

Includes

1. Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) 2. Candida glabrata

Preferred Specimen

1 vaginal swab collected in Aptima® Multitest Transport tube

Minimum Volume

1 swab

Transport Container

Vaginal swab: Follow instructions in the Aptima® Multitest Collection Kit (orange label).

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. The assay is intended to aid in the diagnosis of vulvovaginal candidiasis 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.