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Vaginitis Panel

Additional Codes

LAB9518

Performing Laboratory

MBMC-Microbiology

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:

  1. Anaerobic bacteria associated with BV
    • Atopobium spp.
    • Bacterial Vaginosis-Associated Bacterium 2 (BVAB2)
    • Megasphaera-1
  2. Candida group (C. albicans, C. tropicalis, C. parapsilosis, and/or C. dubliniensis)
  3. Candida glabrata and/or Candida krusei
  4. 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

Specimen Type: Vaginal
Container/Tube: Vaginal Swab collected with Xpert Swab Specimen Collection Kit. Submit Flocked swab
 

Specimen Transport Temperature

Ambient/Refrigerated OK

Day(s) Test Set Up

Monday through Sunday

Turnaround Time:

STAT:  1 hour after receipt in laboratory

Routine:  within 4 hours

Reference Values

Bacterial Vaginosis – Not Detected

Candida group – Not Detected

Candida glabrata/krusei – Not Detected

Trichomonas DNA – Not Detected

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:

  1. Testing of vaginal swab specimens with the Vaginitis Panel is not intended to replace an exam by a clinician.
  2. 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.
  3. This test cannot be used to assess therapeutic success or failure because target nucleic acids may persist following antimicrobial therapy.

 

CPT Code:

85151

Stability

Room temperature or refrigerated: stable for 42 days 

Profile Information

  1. Anaerobic bacteria associated with BV
    • Atopobium spp.
    • Bacterial Vaginosis-Associated Bacterium 2 (BVAB2)
    • Megasphaera-1
  2. Candida group (C. albicans, C. tropicalis, C. parapsilosis, and/or C. dubliniensis)
  3. Candida glabrata and/or Candida krusei
  4. Trichomonas