Test Code LAB9518 Vaginitis Panel PCR
Performing Laboratory
Barnes-Jewish Hospital Molecular Infectious Disease Laboratory
Methodology
Nucleic acid amplification testing (NAAT) for the detection of anaerobic bacteria associated with bacterial vaginosis, Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis using the Cepheid Xpert® MVP Assay performed on the GeneXpert System. The test detects DNA targets for:
- Anaerobic bacteria associated with BV
- Atopobium spp.
- Bacterial Vaginosis-Associated Bacterium 2 (BVAB2)
- Megasphaera-1
- Candida group (C. albicans, C. tropicalis, C. parapsilosis, and/or C. dubliniensis)
- Candida glabrata and/or Candida krusei
- Trichomonas
Note: The Vaginitis Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis, or trichomoniasis. This test in not intended for testing asymptomatic patients. Symptoms of vaginitis include abnormal vaginal discharge, odor, itching, burning, and/or irritation.
Specimen Requirements
Vaginal Swab collected with Xpert Swab Specimen Collection Kit
Refer to collection fliers for STI testing for inpatients and outpatients
Day(s) Test Set Up
Monday through Sunday
Turnaround Time:
Within 8 hours from receipt to the laboratory
Test Classification and CPT Coding
Test Classification:
This test is FDA cleared to aid in the diagnosis of vaginal infections in symptomatic women ages 14 and older. The performance characteristics of this test have been verified by the Barnes-Jewish Hospital Molecular Infectious Disease Laboratory.
Limitations:
- Testing of vaginal swab specimens with the Vaginitis Panel is not intended to replace an exam by a clinician.
- The BV organism targets and Candida species targets of this test can be commensal in women. Results should be considered in conjunction with clinical presentation to determine the disease status.
- This test cannot be used to assess therapeutic success or failure because target nucleic acids may persist following antimicrobial therapy.
CPT Code:
81515
Reference Values
Bacterial Vaginosis – Not Detected
Candida group – Not Detected
Candida glabrata/krusei – Not Detected
Trichomonas DNA – Not Detected
Specimen Transport Temperature
Vaginal Swab collected with Xpert Swab Specimen Collection Kit - Ambient/Refrigerated OK
Additional Information
For BJH Laboratory Use Only
Minimum Volume:
Vaginal Swab: 1 Xpert Swab Specimen Collection Kit