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Test Code LABVAGPR Vaginitis Panel (Candida Species, Gardnerella Vaginalis, and Trichomonas Vaginalis), DNA Probe

Important Note

Assay Limitations: The performance of this test on patient specimens collected during or immediately after antimicrobial therapy is unknown. The presence or absence of Candida species, G. vaginalis, or T. vaginalis cannot be used as a test for therapeutic success or failure.

Infectious

Additional Codes

Test Name in EPIC EPIC Test Code Mnemonic
Vaginitis Panel by Molecular Detection LABVAGPR VAGPR

 

Methodology

BD Affirm:  Nucleic Acid Hybridization

Hologic Panther:  Nucleic Acid Amplification--Real Time Transcription-Mediation Amplification (TMA)

Cepheid GeneXpert: Real-Time Polymerase Chain Reaction (PCR)

 

 

 

Specimen Requirements

Note: Separate swabs should be used for other tests, e.g. culture or microscopic slide samples.

Methodology:  BD Affirm

Specimen Type:  Vaginal Fluid

Container/Tube:  Affirm Temperature Transport System Collection Tube

Collection Instructions:

1.Label tube with patient’s name (first and last), date and actual time of collection, and source/type of specimen.

2. Place the patient in position for a pelvic examination and insert a speculum into the vagina to permit visualization of the posterior vaginal fornix.

3. Using the sterile swab, obtain a sample from the posterior vaginal fornix. Twist or roll the swab against the vaginal walls 2 or 3 times, ensuring the entire circumference of the swab has touched the vaginal wall. Swab the lateral vaginal wall while removing the swab.

4. Immediately place the swab into the Sample Collection Tube (SCT).

5. With the swab touching the BOTTOM of the collection tube, grasp the pre-scored handle of the swab just above the top of the tube and bend until the swab breaks. When the swab is fully inserted into the collection tube, the score mark on the swab is approximately 1 cm above the top of the collection tube. Discard the broken handle into an infectious waste container.

6. Place the cap over the exposed end of the swab and firmly press the cap onto the tube. The cap will "snap" onto the tube when it is properly seated. 

 

Methodology:  Hologic Panther

Specimen Type:  Vaginal Fluid

Container/Tube: Aptima Multitest Swab Specimen Collection Kit

Collection Instructions:

Note: For patient-collected vaginal swab specimen collection, ensure that patients read the Patient Collection Instructions before providing them with a collection kit.

 

Instructions for vaginal swab specimen collection:

  1. Partially peel open the swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
  2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
  3. Carefully insert the swab into the vagina about 2 inches (5 cm) past the introitus and gently rotate the swab clockwise for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab and then withdraw the swab without touching the skin.
  4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest swab Specimen Collection Kit.
  5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
  6. Carefully break the swab shaft at the score line against the side of the tube.
  7. Immediately discard the top portion of the swab shaft.
  8. Tightly screw the cap onto the tube.

 

Methodology: Cepheid GeneXpert: Real-Time Polymerase Chain Reaction (PCR)

Specimen Type: Vaginal Fluid

Container/Tube: Pink-Capped Xpert Swab Transport Reagent Tube

Collection Instructions: Vaginal

 

 

  1. Label tube with patient’s name (first and last), date and actual time of collection, source/type of specimen.
  2. Place the patient in position for pelvic examination and carefully insert the pink-capped Xpert swab into the vagina about 5 cm.

  3. Gently rotate swab for 10-30 seconds. Ensure the swab touches the wall of the vagina so that moisture is absorbed by the swab.

  4. While holding the swab, unscrew the cap from the Xpert Swab Transport Reagent tube. Do not spill the contents of the tube. If the contents are spilled, use a new collection kit. Immediately place the collection swab into the transport tube.

  5. Identifying the scoreline on the collection swab, carefully break the swab shaft against the side of the tube. Re-cap the swab and transport reagent tube and tighten the cap securely. Invert or gently shake the tube 3-4 times to elute material from the swab.

Collection Instructions: Endocervical

 

 

  1. Label tube with patient’s name (first and last), date and actual time of collection, source/type of specimen.
  2. Place the patient in position for pelvic examination. Remove excess mucus from cervical os and surrounding mucosa using the large individually wrapped cleaning swab (discard swab). Once cleaning is completed carefully insert the pink-capped Xpert swab into the vagina about 5 cm.

  3. Gently rotate swab for 10-30 seconds. Ensure the swab touches the wall of the vagina so that moisture is absorbed by the swab.

  4. While holding the swab, unscrew the cap from the Xpert Swab Transport Reagent tube. Do not spill the contents of the tube. If the contents are spilled, use a new collection kit. Immediately place the collection swab into the transport tube.

  5. Identifying the score line on the collection swab, carefully break the swab shaft against the side of the tube. Re-cap the swab and transport reagent tube and tighten the cap securely. Invert or gently shake the tube 3-4 times to elute material from the swab.

 

 

 

 

 

 

 

 

Specimen Transport Temperature

BD Affirm Hologic Panther-Aptima Multitest Swab Cephied GeneXpert

Ambient 72 hours/Refrigerate 72 hours OK/Frozen NO

Ambient 30 days (preferred)/Refrigerate 30 days OK /Frozen 60 days

Ambient/Refrigerated 42 days/Frozen NO

     

 

Day(s) Test Set Up

Monday through Sunday

Special Instructions

See collection requirements under General Information - Essentia Health Common Microbiology-Molecular Collection & Transport Devices

Performing Laboratory

 SJMC Medical Center Lab, Baxter Lab, Park Rapids Clinic Lab

Fargo 32nd Ave Hospital Lab,  Ada Hosptial Lab, Fosston Hospital Lab, Graceville Holy Trinity Hospital Lab, Mid Dakota Clinic 9th Street Lab Bismarck, Mid Dakota Clinic Gateway Lab Bismarck, Mid Dakota Clinic Kirkwood Lab Bismarck,St. Mary's Hosptial Detroit Lakes, West Fargo The Lights Clinic Lab

SMDC Clinical Laboratory,Cloquet Clinic Lab, Deer River Hospital, Hinckley Clinic Lab,Moose Lake Hospital Lab, Northern Pines Lab, Virginia Hospital Lab, Sandstone Hospital Lab, St. Mary's Superior Lab

Test Classification and CPT Coding

 

BD Affirm

Cephied GeneXpert

Hologic Panther-Aptima Multitest Swab

87480 – Candida DNA Probe

87510 – Gardnerella DNA Probe

87660 – Trichomonas vaginalis DNA Probe

0352U

81513 – Bacterial Vaginosis RNA Measurement

87481 – Candida species Amplified Probe

87661 – Trichomonas vaginalis Amplified Probe

 

Reference Values

Not Detected

Turnaround Time

 

 

BD Affirm

Cephied GeneXpert

Hologic Panther-Aptima Multitest Swab

On-site Collection: 90 minutes

Off-site Collection: 24 Hours

On-site Collection:  90 minutes

Off-site Collection:  24 Hours

On-site Collection: 3 Hours

Off-site Collection: 24 Hours