Rapid Multiplex Vaginosis Panel, DNA

Test Code

LAB01207

Alias/See Also

MVP

CPT Codes
0352U

Includes

Bacterial Vaginosis
Candida Group (includes C. albicans, C. tropicalis, C. parapsilosis, and C. dubliniensis but species are not differentiated)
Candida glabrata/krusei
Trichomonas vaginalis

Preferred Specimen

Xpert Swab Specimen Collection Kit
Multiplex Vaginal Panel, NAT - Sanford Laboratories - Bismarck

Transport Temperature

Room Temperature

Specimen Stability

Samples placed in transport medium following collection can be stored for up to 42 days at 2-28°C prior to testing with the Xpert Xpress MVP test.

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Specimens collected on expired swab media.
Specimens not collected on a Xpert Swab Specimen Collection Kit.

Methodology
PCR

Setup Schedule

Daily

Report Available

STAT - 1 hour
Routine - 8 hours

Limitations

• Testing of vaginal swab specimens with the Xpert Xpress MVP test is not intended to replace an exam by a clinician. Vaginal infections may result from other causes or concurrent infections may occur.

• As with many diagnostic tests, results from the Xpert Xpress MVP test should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

• The Xpert Xpress MVP test targets three anaerobic microorganisms that are associated with BV. Other organisms that are not detected by the Xpert Xpress MVP test have also been reported to be associated with BV.

• A Candida group positive result can be due to one or multiple Candida species.

• Candida species can be present as commensal organisms in women; the Xpert Xpress MVP positive results for Candida should be considered in conjunction with other clinical and patient information to determine the disease status.

• The BV organism targets of the Xpert Xpress MVP test can be commensal in women; Xpert Xpress MVP positive results for bacterial vaginosis should be considered in conjunction with other clinical and patient information to determine the disease status.

• False negative results may occur if the organism(s) is present at levels below the analytical limit of detection or below the cut-off concentration.

• Mutations or other changes within the regions of the microbial genomes covered by the primers and/or probes in the Xpert Xpress MVP test may result in failure to detect the target organisms.

• The effects of other potential variables such as vaginal discharge, use of tampons, douching, and specimen collection variables have not been determined.

• The Xpert Xpress MVP test provides qualitative results. No correlation can be drawn between the magnitude of the Ct value and the number of cells in an infected sample.

Reference Range

Not Detected

Clinical Significance

The Xpert® Xpress MVP test, performed on the GeneXpert® Instrument Systems, is an automated qualitative in vitro diagnostic test for the detection of DNA targets from anaerobic bacteria associated with bacterial vaginosis (BV), Candida species associated with vulvovaginal candidiasis, and Trichomonas vaginalis. The Xpert Xpress MVP test uses clinician-collected and self-collected vaginal swabs (collected in a clinical setting) from patients who are symptomatic for vaginitis/vaginosis. The Xpert Xpress MVP test utilizes real-time polymerase chain reaction (PCR) for the amplification of specific DNA targets and utilizes fluorogenic target-specific hybridization probes to detect and differentiate DNA from:
• Organisms associated with bacterial vaginosis (detected organisms not reported individually)
• Atopobium spp. (Atopobium vaginae, Atopobium novel species CCUG 55226)
• Bacterial Vaginosis-Associated Bacterium 2 (BVAB2) • Megasphaera-1
• Candida spp. (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis, species not differentiated)
• Candida glabrata/Candida krusei (species not differentiated)
• Trichomonas vaginalis

The Xpert Xpress MVP test is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis, or trichomoniasis.

Performing Laboratory
LMH Laboratory - Microbiology/Molecular

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.