SureSwab® Advanced Candida Vaginitis (CV), TMA

Test Code

10121

Alias/See Also

YEAST

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 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 • Specimens 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

Candida species	Not detected
Candida glabrata	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. 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.

Performing Laboratory
Quest Diagnostics Nichols Institute
14225 Newbrook Dr
Chantilly, VA 20153

Last Updated: September 29, 2022

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.