CANDIDA VAGINITIS, PCR

LAB3717

10121

Vaginitis

1 vaginal swab collected in Aptima® Multitest Transport tube

1 swab

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

Aptima® Multitest Transport Tube

Room temperature

Room temperature: 30 days
Refrigerated: 30 days
Frozen: 60 days

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 • Patients less than 14 years of age

Daily

2-4 days

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.