New Laboratory Tests and Services
Vaginosis PCR Panel Update
EPIC Procedure Code LAB3677, EPIC ID 121991
Effective March 18, 2024, Geisinger Medical Laboratories (GML) will replace the current vaginosis panel with a new updated vaginosis panel. The panel will include the following targets with the new targets in bold: Candida species (spp.) Result Group (includes C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), Candida glabrata, Trichomonas vaginalis, and the Bacterial Vaginosis Result Group includes Lactobacillus group (including L. gasseri, L. crispatus, and L. jenserii), Gardnerella vaginalis, and Atopobium vaginae.
The biggest change with this update will be the swab used at collection:
- The Vaginosis Panel requires a new collection tube, the Aptima Multitest swab.
- The Copan ESwab will no longer be an acceptable collection device. This test cannot be performed from other Aptima collection devices, only the Multitest swab.
- Switch to use of the new tubes on March 18, 2024.
Indications for use:
The three main categories of vaginitis are bacterial vaginosis, (BV), yeast vaginitis (candidiasis), and T. vaginalis vaginitis (trichomoniasis). The panel includes two tests and is intended to aid in the diagnosis of bacterial vaginosis, vulvovaginal candidiasis, and or trichomoniasis in patients with a clinical presentation consistent with vaginitis and/or vaginosis.
Test Results and Interpretation:
Bacterial Vaginosis Result: positive, negative, or invalid
Candida Species Result: positive, negative, or invalid
Candida Glabrata Result: positive, negative, or invalid
Trichomonas Result: positive, negative, or invalid
Clinical correlation is needed with the detection of bacterial vaginosis, Candida species, Candida glabrata, and Trichomonas vaginalis.
Specimen type: Vaginal swab
Collection container: Aptima Multitest swab
Transport: After collection, swab specimens in transport tubes can be transported at 2°C to 30°C. Swab specimens are stable for up to 30 days at 2 to 30°C.
Limitations: The performance of the assay has not been evaluated in women less than 14 years of age.
