Test Code LAB4567 VAGINITIS PANEL BY PCR
Specimen Type
Vaginal swab in Xpert Swab Specimen Collection Tube (pink top)
Collection Instructions
Vaginal Specimen Collection Instructions:
· Collect swab prior to pelvic, speculum, or bimanual exam.
· No lubricant is used for the sample collection.
· Do not collect at the posterior fornix
- Discard the large cleaning swab. Partially peel open the FLOQSwab in collection kit. Carefully insert the FLOQSwab 2 inches (5 cm) into the vagina.
- Rotate the swab for 10 to 30 seconds. Ensure the swab touches the wall of the vagina.
- Specimen must be transferred immediately into the Xpert Swab Specimen Collection Tube with the pink cap. Insert swab into collection tube and break the shaft at the score mark.
- Tightly recap the tube. Invert or gently shake tube 3-4 times.
- Label the tube with patient information.
- Ship to laboratory at room temperature.
Self-collect vaginal swab also acceptable.
Turnaround Time
24 hours
Test Schedule
Daily 0500-2300
Sample Stability
Vaginal sample must be immediately placed in the Xpert Swab Specimen Collection Tube (pink top). After placing specimen in the Xpert Specimen Collection Tube it is stable for up to 60 days at 2 - 30C.
Method
Cepheid GeneXpert Real-time PCR assay
Reference Ranges
Negative, Positive, or Invalid for Bacterial Vaginosis
Negative, Positive, or Invalid for Candida glabrata/krusei
Negative, Positive, or Invalid for Candida Group
Detected, Not Detected, or Invalid for Trichomonas vaginalis
Synonyms
Vaginitis, Vaginitis Panel, TV, Trich, Candida, Yeast, BV, Bacterial vaginosis
Test Components
Bacterial Vaginosis, Candida glabrata/krusei, Candida Group, Trichomonas Vaginalis:
Infectious disease, bacterial vaginosis and vaginitis, real-time PCR amplification of DNA markers for Atopobium vaginae, Atopobium species, Megasphaera type 1, and Bacterial Vaginosis Associated Bacteria-2 (BVAB-2), utilizing vaginal-fluid specimens, algorithm reported as positive or negative for high likelihood of bacterial vaginosis, includes separate detection of Trichomonas vaginalis and Candida species (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata/Candida krusei, when reported.
CPT Codes
81515
Specimen Rejection Criteria
- Incorrect or expired transport medium
- Any specimen that has leaked
- Improper storage conditions during transport
- Improper sample collection
Limitations
The Xpert Xpress MVP test performance has only been evaluated in patients 14 years of age and older (including pregnant women).