Specimen must be collected using the Cepheid Xpert Vaginal Swab Collection kit.

Bacterial Vaginosis Organism DNA, Candida group DNA, Candida glabrata/krusei, Trichomonas vaginalis

Performed 24 hours/day; results are reported within 5 hours from receipt in IDDL.

The Xpert Xpress MVP test uses clinician-collected and self-collected vaginal swabs from patients who are symptomatic for vaginitis/vaginosis and is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis, or trichomoniasis.

Vaginal

Female Vaginal Self-Collect Specimens

1. Open the outer peel-pack (which contains the two package kit); identify the larger cleaning swab and discard it.
2. Open the package that contains the pink-capped Xpert Swab Transport Reagent tube and individually wrapped collection swab. Open the collection swab wrapper and remove the swab taking care not to touch the tip or lay it down.
3. Hold the swab shaft across the scoreline.
4. Carefully insert the swab into the vagina about 2 inches past the opening of the vagina and gently rotate the swab for 10-30 seconds. Make sure the swab touches the walls of the vagina so that the moisture is absorbed by the swab and then withdraw the swab.
5. While holding the swab in the same hand, unscrew the pink cap from the Xpert Swab Transport Reagent tube. (Do not spill the contents! If the contents of the tube are spilled, then use a new collection kit.)
6. Immediately place the swab in the transport reagent tube.
7. Carefully break the swab shaft against the side of the tube at the scoreline and discard the top portion of the swab shaft; use care to avoid splashing the contents. Wash with soap and water if exposed.
8. Re-cap the swab transport tube and tighten cap securely.
9. Return the tube as instructed by lab staff or provider for appropriate patient labeling.

Swab specimens collected using wrong collection kit; transport tubes containing a cleaning swab or more than 1 swab

Ship at room temperature or refrigerated.

42 days at room temperature or refrigerated.

Negative/Not Detected for all targets

• Candida orthopsilosis was found to cross-react with the Xpert® Xpress MVP test at levels above 1 x 102 CFU/mL.

• Pentatrichomonas hominis, a commensal of the large intestine, was found to cross-react with the Xpert® Xpress MVP test at levels above 5 x 104 CFU/mL.

• Trichomonas tenax, a commensal of the oral cavity, was found to cross-react with the Xpert® Xpress MVP test at levels above 10 cells/mL.

• Interference with the Xpert® Xpress MVP test was observed in the presence of mucin (from porcine stomach) at ≥5.5% v/v.

The Xpert Xpress MVP test performance has not been evaluated in patients less than 14 years of age.