Test Code LAB0299370 Vaginitis Profile, PCR
Methodology
Real-time Polymerase Chain Reaction (RT-PCR) on the Cepheid GeneXpert DX system
Performing Laboratory
CentraCare Laboratory Services
Specimen Requirements
Specimen Type: Vaginal Swab
Container/Tube: Xpert swab specimen collection kit (swab/G-50-US)
Collection:
Clinician Collected Vaginal Swab
1. Open the Xpert Swab Specimen collection kit.
2. Discard the large cleaning swab.
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. 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.
5. Insert collection swab about 5 cm past introitus and rotate gently for 30 seconds.
6. Immediately place collection swab into Xpert Swab Transport Reagent Tube (pink cap) provided in collection kit. Snap off swab at score line so swab fits into closed tube.
7. Cap tube securely and invert the tube 3-4 times to elute material from the swab. Avoid foaming.
8. Label the transport tube with patient label including date of collection and specimen type.
9. Transport and store swab container at 2 to 28° C within 42 days of collection.
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.
Patient Collected Vaginal Swab
Caution: Do not expose swab to Xpert Swab Transport Reagent prior to collection.
STEPS FOR PATIENT TO PERFORM
Wash your hands before starting.
1. Open the outer peel pack (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 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 score line.
6. 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 wall of the vagina so that moisture is absorbed by the swab.
7. Withdraw the swab carefully and continue to hold it in your hand.
8. 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, 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.
10. Immediately place the specimen collection swab into the transport reagent tube.
11. Identify the score line on the collection swab shaft. Carefully break the swab shaft against the side of the tube at the score line and discard the top portion of the swab shaft.
12. Re-cap the swab transport reagent tube and tighten the cap securely.,
13. Return the swab as instructed by your doctor, nurse, or care provider to complete the following steps.
STEPS FOR CAREGIVER TO PERFORM
14. Invert the tube 3-4 times to elute material from the swab. Avoid foaming.
15. Label the transport reagent tube with the patient label including date of collection and specimen type.
16. Transport and store swab container at 2-28° C (refrigeration is preferred temperature) within 42 days of collection.
Sample Rejection:
Large white swab included in Xpert Swab Specimen Collection Kit is for preparatory cleaning of the endocervix and is unacceptable for testing. Specimens in swab transport media without a swab. Specimen not submitted in appropriate transport container; improperly labaeled specimen; midstream urine; Cath urine, vaginal drainage, urethral swabs; insufficient volume; external contamination; specimens exceeding acceptable transport time.
Specimen Transport Temperature
2-280C for 42 days
Reference Values
Bacterial Vaginosis - Negative
Candida species - Not detected
Candida glabrata/ krusei - Not detected
Trichomonas vaginalis - Not detected
Day(s) Test Set Up
Monday through Sunday
Test Classification and CPT Coding
0352U