SureSwab® Advanced Bacterial Vaginosis (BV), TMA
Also known as: Vaginitis, vaginal discharge, Leukorrhea, Vaginal itching, Vulvovaginitis
Use
This Food and Drug Administration (FDA)-cleared transcription-mediated amplification (TMA)–based test is intended to aid in the diagnosis of bacterial vaginosis (BV) using clinician-collected or patient-collected vaginal swab specimens in individuals with a clinical presentation consistent with vaginitis and/or vaginosis. It qualitatively detects ribosomal RNA from bacteria associated with BV (Lactobacillus: L. gasseri, L. crispatus, L. jensenii; Gardnerella vaginalis; Atopobium vaginae) and applies a proprietary algorithm to report a simple positive/negative result; individual organisms are not reported.
Special Instructions
Not provided.
Limitations
The test reports only qualitative results for BV (positive or negative) and does not provide results for individual organisms; differentiation between organisms is not possible and does not affect treatment decisions.
FDA Approved
Methodology
NGS
Biomarkers
Result Turnaround Time
1 day
Related Documents
For more information, please review the documents below
Specimen
Vaginal Swab
Volume
Not provided
Minimum Volume
Not provided
Container
Aptima® Multitest transport tube
Collection Instructions
1 vaginal swab collected in an Aptima® Multitest transport tube; follow instructions in the Aptima® Multitest Collection Kit (orange label)
Causes for Rejection
Transport tube with no swab; 2 swabs; cleaning swab; non‑Aptima® swabs; swab inverted; viral transport media; excess mucus; Aptima® tubes with pierced foil lids
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 30 days |
| Refrigerated | 30 days |
| Frozen | 60 days |