Epic ID

LAB2830

Performing Lab

PVH Lab, Microbiology
MCR Lab, Microbiology
GH Lab, Microbiology

Collect

  1. Only use the Cepheid Xpert Swab Collection Kit. Obtain swab kits from the microbiology department if needed.
  2. Any other swab (Eswab, etc) is not acceptable and will be rejected and require re-collection.
  3. Both clinician-collect and patient self-collect in a clinical setting are acceptable.
  4. Open the Cepheid Xpert Swab Collection Kit. There will be two packages inside.
  • Discard the package with the LARGE swab into regular trash.
  • Keep the package with the pink capped tube and smaller swab for collection.
  • Collect the sample following manufacturer’s instructions (see link at bottom of page), then place swab into the pink capped vial and break off at score mark.
  • Securely cap, apply patient label with two identifiers, and send to laboratory as soon as possible.
  1. See link to manufacturer’s complete collection instructions HERE. 

Unacceptable Conditions

  • Culturette Swabs
  • Eswabs
  • Swabs collected on males
  • Large cleaning swab instead of collections swab

Storage/Transport Temperature

Ambient
Refrigerated

Stability (from collection to initiation)

42 days maximum

Performed

Medical Center of the Rockies lab- all hours, 7 days/week
Poudre Valley Hospital Lab- all hours, 7 days/week
Greeley Hospital- all hours, 7 days/week

Remarks

Technical Bulletin from Cepheid can be found HERE on why Gardnerella vaginalis nor Lactobacillus species are included on the panel.

Performed

Medical Center of the Rockies lab- all hours, 7 days/week
Poudre Valley Hospital Lab- all hours, 7 days/week
Greeley Hospital- all hours, 7 days/week

Methodology

Cepheid GeneXpert, RT-PCR

Synonyms

  • Vaginosis Panel
  • MVP PCR
  • Multiplex Vaginal Panel PCR

Epic ID

LAB2830

Reference Interval

Bacterial vaginosisNegative
Candida group
*Candida group contains C. albicans and/or C. tropicalis and/or C. parapsilosis and/or C. dubliniensis.		Not detected
Candida glabrata/Candida kruseiNot detected
Trichomonas vaginalisNot 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

  • 87801 – Bacterial Vaginosis
  • 87481 – Candida group
  • 87481 – Candida glabrata/krusei
  • 87661 – Trichomonas vaginalis
Collection

Epic ID

LAB2830

Performing Lab

PVH Lab, Microbiology
MCR Lab, Microbiology
GH Lab, Microbiology

Collect

  1. Only use the Cepheid Xpert Swab Collection Kit. Obtain swab kits from the microbiology department if needed.
  2. Any other swab (Eswab, etc) is not acceptable and will be rejected and require re-collection.
  3. Both clinician-collect and patient self-collect in a clinical setting are acceptable.
  4. Open the Cepheid Xpert Swab Collection Kit. There will be two packages inside.
  • Discard the package with the LARGE swab into regular trash.
  • Keep the package with the pink capped tube and smaller swab for collection.
  • Collect the sample following manufacturer’s instructions (see link at bottom of page), then place swab into the pink capped vial and break off at score mark.
  • Securely cap, apply patient label with two identifiers, and send to laboratory as soon as possible.
  1. See link to manufacturer’s complete collection instructions HERE. 

Unacceptable Conditions

  • Culturette Swabs
  • Eswabs
  • Swabs collected on males
  • Large cleaning swab instead of collections swab

Storage/Transport Temperature

Ambient
Refrigerated

Stability (from collection to initiation)

42 days maximum

Performed

Medical Center of the Rockies lab- all hours, 7 days/week
Poudre Valley Hospital Lab- all hours, 7 days/week
Greeley Hospital- all hours, 7 days/week

Remarks

Technical Bulletin from Cepheid can be found HERE on why Gardnerella vaginalis nor Lactobacillus species are included on the panel.
Ordering

Performed

Medical Center of the Rockies lab- all hours, 7 days/week
Poudre Valley Hospital Lab- all hours, 7 days/week
Greeley Hospital- all hours, 7 days/week

Methodology

Cepheid GeneXpert, RT-PCR

Synonyms

  • Vaginosis Panel
  • MVP PCR
  • Multiplex Vaginal Panel PCR

Epic ID

LAB2830
Result Interpretation

Reference Interval

Bacterial vaginosisNegative
Candida group
*Candida group contains C. albicans and/or C. tropicalis and/or C. parapsilosis and/or C. dubliniensis.		Not detected
Candida glabrata/Candida kruseiNot detected
Trichomonas vaginalisNot 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

  • 87801 – Bacterial Vaginosis
  • 87481 – Candida group
  • 87481 – Candida glabrata/krusei
  • 87661 – Trichomonas vaginalis

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