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Test Code LAB10017 MPLEX Vaginitis Panel

Performing Lab

Arnot Ogden Medial Center

Ordering Recommendations

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.

Collect

Vaginal swab specimen in Xpert Swab Transport (pink top)

 

Collection Device

Xpert Swab Collection Device (obtain from laboratory) (pink top)

Stability (from collection to initiation)

Samples placed in transport medium following collection are stable for up to 42 days at 2-28°C.

Storage/Transport Temperature

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. Transport at 2-28C.

Methodology

Real-time PCR

Start Date

8/21/2023

Last Review Date

6/24/2025

Performed

Daily

Reference Interval

Negative/Not Detected

Interpretive Data

Negative/Not Detected:
Indicator DNA not present or present at a level below the limit of detection for the assay.

Positive/Detected:
Indicator DNA present at a level above the limit of detection for the assay.
 

LIMITATIONS:

  • The Xpert Xpress MVP test has been validated using the procedures provided in the Instructions for Use only. Modification to these procedures may alter the performance of the test.
  • The Xpert Xpress MVP test has been validated with vaginal swabs collected with the Xpert Swab Specimen Collection Kit.
  • 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.
  • Public health recommendations should be consulted regarding testing for additional sexually transmitted diseases for patients with a positive result for bacterial vaginosis (BV) or T. vaginalis with the Xpert Xpress MVP test.
  • 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.
  • 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. Careful compliance with the instructions in this Instructions for Use and to the Xpert Swab Collection Kit instruction document are necessary to avoid erroneous results.
  • A negative test result does not exclude the possibility of infection because test results may be affected by improper specimen collection, technical error, specimen 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(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.
  • The Xpert Xpress MVP test performance has been evaluated in patients 18 years of age and older (including pregnant women).
  • 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.
  • Five strains of Candida albicans evaluated in the Inclusivity Study were detected by the Xpert Xpress MVP test. Three of the strains were only detected at concentrations higher than 3× LoD (one strain at 4× LoD and two strains at 20× LoD).
  • Eleven strains of Atopobium spp. evaluated in the Inclusivity Study were detected by the Xpert Xpress MVP test. Four of the strains were only detected at concentrations higher than 3× near cut-off concentration (ranging from 4× and 12×).
  • Candida orthopsilosis, a recently described species that has been grouped previously with C. parapsilosis, was found to cross-react with the Xpert Xpress MVP test at levels above 1×102 CFU/mL. Pentatrichomonas hominis (a commensal of the large intestine) was found to cross-react with the Xpert Xpress MVP test at levels above 5×104 cells/mL. Trichomonas tenax (a commensal of the oral cavity) was found to cross-react with the Xpert Xpress MVP test at levels above 10 cells/mL. See Xpert Xpress MVP Analytical Specificity for details.
  • Interference with the Xpert Xpress MVP test was observed in the presence of mucin (from porcine stomach) (≥5.5% v/v). See Xpert Xpress MVP Potentially Interfering Substances Study for details.
  • The analyte target may persist in vivo, independent of pathogen viability. Detection of the analyte target does not imply that the corresponding pathogen is infectious, or is the causative agent of the clinical symptoms.
  • The Xpert Xpress MVP test cannot be used to assess therapeutic success or failure since target nucleic acids may persist following antimicrobial therapy.


 

Unacceptable Conditions

Reasons for rejections include, but are not limited to, the following:

  • Specimens that do not meet the current laboratory labeling policy
  • Specimens collected from sites other than vaginal/endocervical
  • Specimens that have not been held or transported under the correct conditions
  • Specimens that are older than 42 days
  • Specimens collected with an expired collection device

Lab Section

Microbiology

Collection Instructions

Patient-collected Vaginal Swab Specimen Collection
Caution: Do NOT expose swab to Xpert Swab Transport Reagent prior to collection.
Caution: Wash your hands before starting.
Note: If you have any questions about this procedure, please ask your doctor, nurse, or care-provider.

1. In the privacy of the examination room or restroom, undress from the waist down. Comfortably position yourself to maintain balance during the collection procedure.
2. Open the outer peelpack (which contains the two-package kit), and identify the larger cleaning swab and discard it.
3. Open the package that contains the pink-capped Xpert Swab Transport Reagent tube and individually wrapped collection swab. Set the tube aside before beginning to collect sample.
4. Open the collection swab wrapper by peeling open the top of the wrapper.
5. Remove the swab, taking care not to touch the tip or lay it down. If the soft tip is touched, the swab is laid down, or the swab is dropped, request a new collection kit.
6. Hold the swab in your hand, placing your thumb and forefinger in the middle of the swab shaft across the scoreline.
7. Carefully insert the swab into your vagina about 5 cm (two inches) inside the opening of the vagina and gently rotate the swab for 10 to 30 seconds. Ensure the swab touches the walls of the vagina so that moisture is absorbed by the swab.
8. Withdraw the swab carefully and continue to hold it in your hand.
9. While holding the swab in the same hand, unscrew the pink cap from the Xpert Swab Transport Reagent tube.
10. Do not spill the contents of the tube. If the contents of the tube are spilled, request a new collection kit.

WARNING: If the contents of the tube are spilled on your skin, wash the affected area with soap and water. If the contents of the tube are splashed in your eyes, immediately flush your eyes with water. Notify your doctor, nurse or care-provider if irritation develops. If the contents of the tube are spilled, your test result may be invalidated. Do not take internally. 
11. Immediately place the specimen collection swab into the transport reagent tube.
12. Identify the scoreline on the collection swab shaft. Carefully break the swab shaft against the side of the tube at the scoreline and discard the top portion of the swab shaft. If needed, gently rotate the swab shaft to complete the breakage. Use care to avoid splashing contents on the skin. Wash with soap and water if exposed. 13. Re-cap the swab transport reagent tube and tighten the cap securely
14. Label the transport tube with full name and date of birth, date of collection, time of collection.

Clinician-collected Vaginal Swab Specimen Collection
Caution: Do NOT expose swab to Xpert Swab Transport Reagent prior to collection.
Caution: Wash your hands before starting.
1. Open the outer peelpack (which contains the two-package kit), and identify the larger cleaning swab and discard it.
2. Open the package that contains the pink-capped Xpert Swab Transport Reagent tube and individually wrapped collection swab. Set the tube aside before beginning to collect sample.
3. Open the collection swab wrapper by peeling open the top of the wrapper.
4. Remove the swab, taking care not to touch the tip or lay it down. If the soft tip is touched, the swab is laid down, or the swab is dropped, request a new collection kit.
5. Hold the swab in your hand, placing your thumb and forefinger in the middle of the swab shaft across the scoreline.
6. Carefully insert the swab into patient’s vagina about 5 cm (two inches) inside the opening of the vagina and gently rotate the swab for 10 to 30 seconds. Ensure the swab touches the walls of the vagina so that moisture is absorbed by the swab.
7. Withdraw the swab carefully and continue to hold it in your hand.
. While holding the swab in the same hand, unscrew the pink cap from the Xpert Swab Transport Reagent tube. 9. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new collection kit. WARNING: If the contents of the tube are spilled on your skin, wash the affected area with soap and water. If the contents of the tube are splashed in your eyes, immediately flush your eyes with water.
10. Immediately place the swab into the transport reagent tube.
11. Identify the scoreline on the collection swab shaft. Carefully break the swab shaft against the side of the tube at the scoreline and discard the top portion of the swab shaft; use care to avoid splashing the contents. Wash with soap and water if exposed.
12. Re-cap the swab transport reagent tube and tighten the cap securely.
13. Invert or gently shake the tube 3-4 times to elute material from the swab. Avoid foaming.
14. Label the transport tube with full name and date of birth, date of collection, time of collection.

Clinician-collected Endocervical Swab Specimen Collection
Caution: Do NOT expose swab to Xpert Swab Transport Reagent prior to collection.
1. Open the Xpert Swab Specimen collection kit.
2. Before collecting the endocervical specimen with the Xpert Swab Specimen Collection Kit, remove excess mucus from the cervical os and surrounding mucosa using the large individually wrapped cleaning swab. Partially peel open the cleaning swab wrapper and remove the swab. Clean the cervical os and surrounding mucosa and then discard the swab. Note: If collecting multiple specimens, excess mucus need only be removed once.
3. Open the package that contains the pink-capped Xpert Swab Transport Reagent tube and the individually wrapped collection swab. Set the tube aside before proceeding.
4. Open the collection swab wrapper by peeling open the top of the wrapper.
5. Remove the swab, taking care not to touch the tip or lay it down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Xpert Swab Specimen Collection Kit.
6. Insert the collection swab into the endocervical canal.
7. Gently rotate the swab clockwise for 10 to 30 seconds in the endocervical canal to ensure adequate sampling.
8. Withdraw the swab carefully.
9. While holding the swab in the same hand, unscrew the cap from the Xpert Swab Transport Reagent tube.
10. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new collection kit. WARNING: If the contents of the tube are spilled on your skin, wash the affected area with soap and water. If the contents of the tube are splashed in your eyes, immediately flush your eyes with water.
11. Immediately place the swab into the transport reagent tube.
12. Identify the scoreline on the collection swab shaft. Carefully break the swab shaft against the side of the tube at the scoreline and discard the top portion of the swab shaft; use care to avoid splashing the contents. Wash with soap and water if exposed.
13. Re-cap the swab transport reagent tube and tighten the cap securely.
14. Invert or gently shake the tube 3-4 times to elute material from the swab. Avoid foaming.
15. Label the transport tube with the full name, date of birth, collection date, collection time.

Reported

Same shift

Notes

Assay run time: approximately 60 minutes