SureSwab® Advanced Candida Vaginitis (CV), TMA

Test Code

10121

CPT Codes
87481 (x2)

Includes

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

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)

Performance of the assay has not been evaluated in women 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

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 • Specimen in broken containers • Specimens in leaking containers • Swab submitted in viral transport media • Patients less than 14 years of age

Methodology
Transcription Mediated Amplification (TMA)

Setup Schedule

Set up: Daily; Report available: Next day

Clinical Significance

This test is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis. 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 using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis or vulvovaginitis.

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.