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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:

  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

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:

  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:

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