SureSwab® Advanced Vaginitis, TMA

Also known as: Fishy odor discharge, Vulvovaginitis, Vaginal yeast, Leukorrhea, Vaginal itching

Clinical Use

Use

The assay is intended to aid in the diagnosis of vaginitis using clinician‑collected or patient‑collected vaginal swab specimens from individuals with a clinical presentation consistent with vaginitis. It includes testing for bacterial vaginosis (BV) via detection of rRNA from BV-associated bacteria (Lactobacillus gasseri, L. crispatus, L. jensenii; Gardnerella vaginalis; Atopobium vaginae), and qualitatively reports BV, and separately tests for vulvovaginal candidiasis (Candida species group and Candida glabrata) and Trichomonas vaginalis using transcription‑mediated amplification (TMA) technology.

Special Instructions

Not provided.

Limitations

For the BV portion, results are reported only as positive or negative for BV and do not report individual organisms. For the Candida and Trichomonas portions, results are qualitative and do not specify individual Candida species beyond group detection. Specimen must be collected using Aptima® Multitest Collection Kit; improper swabs or handling (e.g., non-Aptima swabs, inverted swabs, cleaning swab, excess mucus) may cause rejection.

Test Details

Methodology

NGS

Biomarkers

4 targets

Bacterial vaginosis (BV) rRNACandida glabrataCandida species groupTrichomonas vaginalis

LOINC Codes

Result Codes

94420‑7
47000‑5

Result Turnaround Time

1 day

Specimen

Vaginal Swab

Volume

Not provided

Minimum Volume

Not provided

Container

Aptima® Multitest transport tube

Collection Instructions

Follow instructions in the Aptima® Multitest Collection Kit (orange label)

Causes for Rejection

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