EPIC Code

LAB2830
MVP PCR

Performing Lab

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Collect

  • Vaginal swab (clinician- or self-collected)
Collect using the Xpert® Swab Specimen Collection Kit (Lawson: 397882).

Specimen Preparation

Discard the large swab in package. Follow vaginal collection instructions in kit package or manufacturer’s instructions here. Make sure to place the collection swab in the Xpert® Swab media (do not use the large cleaning swab).

Do not use any other swab type, including eSwabs®.

Unacceptable Conditions

  • Sources other than vaginal.
  • Samples not submitted in the Xpert® Swab Specimen Collection Kit.
  • Samples containing the cleaning swab (large swab) instead of the collection swab.
  • Frozen swabs.
  • ESwab®.
  • Sample not properly identified, incorrect container, insufficient volume, or past stability.

Storage/Transport Temperature

Ambient or refrigerated

Performed

Daily

Stability (from collection to initiation)

Room Temp: 42 days
Refrigerated: 42 days
Frozen: Unacceptable

Remarks

This assay may be used in the detection and differentiation of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis (TV) using vaginal swabs from patients who are symptomatic.

Effective February 14th, 2023: The bacterial vaginosis Gram stain (BVGS) and the BD Affirm DNA-probe vaginosis panel were discontinued and replaced with this multiplex vaginal panel (MVP PCR).

Notes

Trichomonas (TRICHAMP) on vaginal sources ordered in duplicate with the MVP PCR will be cancelled.

Performed

Daily

Methodology

Qualitative Real-time PCR using Cepheid® GeneXpert®

Reported

Same day

Synonyms

  • MVP PCR
  • Vaginosis Panel
  • Vaginitis Panel
  • Multiplex Vaginal Panel PCR

EPIC Code

LAB2830
MVP PCR

Reference Interval

Bacterial vaginosis Negative
Candida group
*Candida group contains C. albicans and/or C. tropicalis and/or C. parapsilosis and/or C. dubliniensis.		 Not detected
Candida glabrata/Candida krusei Not detected
Trichomonas vaginalis Not detected

Interpretive Data

Interpretation:
For Bacterial vaginosis—
Positive = DNA targets related to bacterial vaginosis organisms detected.
Negative = No DNA targets related to bacterial vaginosis organisms were detected.

For Candida group, Candida glabrata/krusei, Trichomonas vaginalis—
Not detected = Absence of organism DNA
Detected = Presence of organism DNA

Methodology:
This assay employs real-time PCR amplification for the detection of DNA targets from anaerobic bacteria (Atopobium spp, Megasphaera-1, Bacterial Vaginosis Associated Bacteria 2), associated with bacterial vaginosis,  Candida species (C. albicans, C. tropicalis, C. dubliniensis, C. parapsilosis) associated with vulvovaginal candidiasis, and Trichomonas vaginalis, the causative agent of trichomoniasis. Both clinician-collected and self-collected vaginal swabs (collected in a clinical setting) showed equivalent sensitivity and specificity, and can be tested on patients who are symptomatic for vaginitis/vaginosis. A "Detected" result should be coupled with clinical indicators for diagnosis. A "Not detected" result for this assay does not exclude bacterial or yeast involvement in a disease process.  This assay has been approved by the U.S. Food and Drug Administration for testing vaginal specimens collected using the Cepheid Xpert Swab Collection Kit. This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.

CPT Codes

0352U
Collection

EPIC Code

LAB2830
MVP PCR

Performing Lab

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Collect

  • Vaginal swab (clinician- or self-collected)
Collect using the Xpert® Swab Specimen Collection Kit (Lawson: 397882).

Specimen Preparation

Discard the large swab in package. Follow vaginal collection instructions in kit package or manufacturer’s instructions here. Make sure to place the collection swab in the Xpert® Swab media (do not use the large cleaning swab).

Do not use any other swab type, including eSwabs®.

Unacceptable Conditions

  • Sources other than vaginal.
  • Samples not submitted in the Xpert® Swab Specimen Collection Kit.
  • Samples containing the cleaning swab (large swab) instead of the collection swab.
  • Frozen swabs.
  • ESwab®.
  • Sample not properly identified, incorrect container, insufficient volume, or past stability.

Storage/Transport Temperature

Ambient or refrigerated

Performed

Daily

Stability (from collection to initiation)

Room Temp: 42 days
Refrigerated: 42 days
Frozen: Unacceptable

Remarks

This assay may be used in the detection and differentiation of bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and trichomoniasis (TV) using vaginal swabs from patients who are symptomatic.

Effective February 14th, 2023: The bacterial vaginosis Gram stain (BVGS) and the BD Affirm DNA-probe vaginosis panel were discontinued and replaced with this multiplex vaginal panel (MVP PCR).

Notes

Trichomonas (TRICHAMP) on vaginal sources ordered in duplicate with the MVP PCR will be cancelled.
Ordering

Performed

Daily

Methodology

Qualitative Real-time PCR using Cepheid® GeneXpert®

Reported

Same day

Synonyms

  • MVP PCR
  • Vaginosis Panel
  • Vaginitis Panel
  • Multiplex Vaginal Panel PCR

EPIC Code

LAB2830
MVP PCR
Result Interpretation

Reference Interval

Bacterial vaginosis Negative
Candida group
*Candida group contains C. albicans and/or C. tropicalis and/or C. parapsilosis and/or C. dubliniensis.		 Not detected
Candida glabrata/Candida krusei Not detected
Trichomonas vaginalis Not detected

Interpretive Data

Interpretation:
For Bacterial vaginosis—
Positive = DNA targets related to bacterial vaginosis organisms detected.
Negative = No DNA targets related to bacterial vaginosis organisms were detected.

For Candida group, Candida glabrata/krusei, Trichomonas vaginalis—
Not detected = Absence of organism DNA
Detected = Presence of organism DNA

Methodology:
This assay employs real-time PCR amplification for the detection of DNA targets from anaerobic bacteria (Atopobium spp, Megasphaera-1, Bacterial Vaginosis Associated Bacteria 2), associated with bacterial vaginosis,  Candida species (C. albicans, C. tropicalis, C. dubliniensis, C. parapsilosis) associated with vulvovaginal candidiasis, and Trichomonas vaginalis, the causative agent of trichomoniasis. Both clinician-collected and self-collected vaginal swabs (collected in a clinical setting) showed equivalent sensitivity and specificity, and can be tested on patients who are symptomatic for vaginitis/vaginosis. A "Detected" result should be coupled with clinical indicators for diagnosis. A "Not detected" result for this assay does not exclude bacterial or yeast involvement in a disease process.  This assay has been approved by the U.S. Food and Drug Administration for testing vaginal specimens collected using the Cepheid Xpert Swab Collection Kit. This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.
Administrative

CPT Codes

0352U

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