Any specimens other than vaginal Any collection device other than the Cepheid Xpert swab Frozen specimens
Collection Comments
This test is approved for vaginal swabs utilizing the Pink Xpert Swab Specimen Collection Kit, obtainable on patient units. Specimen site, date/time of collection and collector's initials are required for processing.
Only use the small swab, break at score line and leave small collection swab in media.
DISCARD SINGLE LARGE SWAB, specimen will be rejected if this swab is placed in media. This swab is not needed for a vaginal collection.
Storage/Transport Temperature
Room Temperature or Refrigerated
Stability (from collection to initiation)
Room Temperature: 42 days; Refrigerated: 42 days
Ordering Recommendations
A Trichomonas Prep for a vaginal specimen includes a DNA probe for the presence of the sexually transmitted protozoan parasite Trichomonas vaginalis. A physician may order this test if the patient has symptoms of a T. vaginalis infection such as difficulty, pain and/or discomfort during urination or a foul-smelling vaginal discharge.
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. 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
Performed
Monday - Sunday; Days, Evenings, Nights
Methodology
Multiplexed real-time RT-PCR test
Reported
24 hours
Performing Lab
Microbiology
Other Performing Labs
Arnett, Ball, and Bloomington
Synonyms
12294
Bacterial Vaginosis
Candida glabrata - krusei
Candida Group
Trichomonas vaginalis
Xpert Xpress MVP
Vaginal Panel
Vaginal PCR
Bacterial Vaginosis PCR
Trichomonas PCR
Reference Interval
Bacterial vaginosis (BV): Negative
Candida Group: Not Detected
Candida glabrata-krusei: Not Detected
Trichomonas DNA: Not Detected
Unresolved results due to PCR inhibition are inconclusive. Consider repeat collection if clinically indicated.
Assay Limitation(s)
- The Xpert Xpress MVP test has not been validated for use with vaginal swab specimens collected by patients at home. The self-collected vaginal swab specimen application is limited to healthcare facilities where support/counseling is available to explain procedures and precautions
- 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.
- The effects of other potential variable 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.
- The Xpert Xpress MVP test performance has been evaluated in patients 14 years of age and older (including pregnant women). Clinical correlation is still recommended for patients < 14 years of age.
- The Xpert Xpress MVP test cannot be used to assess therapeutic success or failure since target nucleic acids may persist following antimicrobial therapy.
Clinical Interpretation
- 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 results can be due to one or multiple Candida species. Xpress MVP positive results for Candida and/or BV should be considered in conjunction with other clinical and patient information to determine the disease status. Detection of the analyte does not imply that the corresponding pathogen is infectious or is the causative agent of the clinical symptoms.
- Erroneous test results might occur from improper specimen collection, technical error, sample mix-up, or because the number of organisms in the specimen is not detected by the test.
- A negative test results does not exclude the possibility of infection because test results may be affected by improper specimen collection, technical error, sample mix-up, concurrent antibiotic therapy, or the number of organisms in the specimen that may be below the sensitivity of the tests.
- False negative results may occur if the organism is present at levels below the analytical limit of detection or below the cut-off concentration.
- Mutations of 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.
CPT Codes
81515
Test Code (Outreach Synonym)
12294
Catalog Code
12935887697
Collection
Test Information
For Jay (ED and inpatients), North, Fishers, and West please order the Trichomonas Prep order.
Please Note: A separate collection kit should be collected from the Chlamydia Gonorrhea collection when both are ordered.
Any specimens other than vaginal Any collection device other than the Cepheid Xpert swab Frozen specimens
Collection Comments
This test is approved for vaginal swabs utilizing the Pink Xpert Swab Specimen Collection Kit, obtainable on patient units. Specimen site, date/time of collection and collector's initials are required for processing.
Only use the small swab, break at score line and leave small collection swab in media.
DISCARD SINGLE LARGE SWAB, specimen will be rejected if this swab is placed in media. This swab is not needed for a vaginal collection.
Storage/Transport Temperature
Room Temperature or Refrigerated
Stability (from collection to initiation)
Room Temperature: 42 days; Refrigerated: 42 days
Ordering
Ordering Recommendations
A Trichomonas Prep for a vaginal specimen includes a DNA probe for the presence of the sexually transmitted protozoan parasite Trichomonas vaginalis. A physician may order this test if the patient has symptoms of a T. vaginalis infection such as difficulty, pain and/or discomfort during urination or a foul-smelling vaginal discharge.
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. 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
Performed
Monday - Sunday; Days, Evenings, Nights
Methodology
Multiplexed real-time RT-PCR test
Reported
24 hours
Performing Lab
Microbiology
Other Performing Labs
Arnett, Ball, and Bloomington
Synonyms
12294
Bacterial Vaginosis
Candida glabrata - krusei
Candida Group
Trichomonas vaginalis
Xpert Xpress MVP
Vaginal Panel
Vaginal PCR
Bacterial Vaginosis PCR
Trichomonas PCR
Result Interpretation
Reference Interval
Bacterial vaginosis (BV): Negative
Candida Group: Not Detected
Candida glabrata-krusei: Not Detected
Trichomonas DNA: Not Detected
Unresolved results due to PCR inhibition are inconclusive. Consider repeat collection if clinically indicated.
Assay Limitation(s)
- The Xpert Xpress MVP test has not been validated for use with vaginal swab specimens collected by patients at home. The self-collected vaginal swab specimen application is limited to healthcare facilities where support/counseling is available to explain procedures and precautions
- 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.
- The effects of other potential variable 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.
- The Xpert Xpress MVP test performance has been evaluated in patients 14 years of age and older (including pregnant women). Clinical correlation is still recommended for patients < 14 years of age.
- The Xpert Xpress MVP test cannot be used to assess therapeutic success or failure since target nucleic acids may persist following antimicrobial therapy.
Clinical Interpretation
- 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 results can be due to one or multiple Candida species. Xpress MVP positive results for Candida and/or BV should be considered in conjunction with other clinical and patient information to determine the disease status. Detection of the analyte does not imply that the corresponding pathogen is infectious or is the causative agent of the clinical symptoms.
- Erroneous test results might occur from improper specimen collection, technical error, sample mix-up, or because the number of organisms in the specimen is not detected by the test.
- A negative test results does not exclude the possibility of infection because test results may be affected by improper specimen collection, technical error, sample mix-up, concurrent antibiotic therapy, or the number of organisms in the specimen that may be below the sensitivity of the tests.
- False negative results may occur if the organism is present at levels below the analytical limit of detection or below the cut-off concentration.
- Mutations of 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.
