Specimen Requirements

Stability

Days Performed

Mon - Sun

Turnaround Time

1 - 4 days

Methodology

Reference Range

Special Info

Microbiology Preanalytic Guidance: http://portals.ccf.org/plmi/Laboratory-Medicine/Microbiology-Specimen-Collection-Transport-Information. The specimen must be a vaginal swab collected and transported using the Aptima Multitest Swab Specimen Collection Kit. Up to two tests can be run on a single Aptima Multitest Swab specimen (ie. GCCT+CVTV or CVTV+BVAMP) - if specimen sources have been correctly selected, the shared tests will print on the same label. Do not place more than one label on a single collection tube. Specimens collected from a non-vaginal source, with an inappropriate or expired collection device, or containing >1 swab may be rejected. Related alternative orders: 1. TRVAMP: in-house Trichomonas vaginalis standalone NAAT (use when complicated vulvovaginal candidiasis is not on the differential). 2. CANSTN: in-house vaginal smear for yeast (use when diagnosing uncomplicated vulvovaginal candidiasis). 3. BVCNSM: in-house vaginal smear gram stain for bacterial vaginosis diagnosis by Nugent score and microscopic exam for yeast (use when both BV and uncomplicated vulvovaginal candidiasis are on the differential). 4. FUNGSC: in-house fungal culture for yeast (use for diagnosis of candida vaginitis in cases where wet mount is negative but disease is still suspected, and/or complicated vulvovaginal candidiasis is suspected). Note that the Aptima Multitest Swab Specimen cannot be used to add-on FUNGSC. Please refer to FUNGSC test directory entry for specimen collection requirements and details.

Clinical Info

Vaginitis syndrome is characterized by a spectrum of conditions including vaginal and vulvar irritation, odor, discharge and pruritus. Causes of vaginitis include mechanical and chemical factors (feminine hygiene products, contraceptive materials, etc.) as well as infectious agents. Up to 90% of infectious vaginitis cases are caused by bacterial vaginosis (BV), vulvovaginal candidiasis (candida vaginitis, CV) and trichomoniasis (Trichomonas vaginalis, TV). BV has been diagnosed in 22-50% of symptomatic patients, CV in 17-39%, and TV in 4-35%. The Aptima CV/TV assay is an FDA-cleared in vitro nucleic acid amplification test (NAAT) for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay utilizes real time transcription-mediated amplification (TMA) to detect and qualitatively report results for the following organisms: • Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) • Candida glabrata • Trichomonas vaginalis The assay differentiates between Candida glabrata and the Candida species group (C spp) by targeting the RNA component of RNAse P ribonucleoprotein; the assay does not differentiate among C spp. For Trichomonas vaginalis, the assay targets ribosomal RNA (rRNA) and differentiates the result from results for Candida glabrata and C spp. The assay is intended to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis on the automated Panther system using clinician-collected and patient-collected vaginal swab specimens from patients with a clinical presentation consistent with vaginitis or vulvovaginitis. CV and TV may be detected by microscopy, culture, and nucleic acid using specimens collected with vaginal swabs. Use of this NAAT should be reserved diagnosis of complicated vulvovaginal candidiasis where identification of Candida glabrata (not easily recognized on microscopy due to lack of pseudohyphae/hyphae, increased azole resistance) may be important. Trichomonas only testing by NAAT is available as a stand-alone test (order code TRVAMP) when complicated vulvovaginal candidiasis is not on the differential. Fungal culture is available as a stand-alone test (order code FUNGSC) and is the test of choice when trying to recover a fungal isolate for potential susceptibility testing. FUNGSC cannot be added onto the Aptima Multitest Swab Specimen – please refer to FUNGSC test directory entry for specimen collection requirements and details.

Clinical Limitation

1. The performance of the assay has not been evaluated in patients <14 years of age. 2. Therapeutic failure or success cannot be determined with the assay since nucleic acid may persist following appropriate antimicrobial therapy. 3. A negative result does not preclude a possible infection because results are dependent on adequate specimen collection. Test results may be affected by improper specimen collection, technical error, specimen mix-up, or target levels below the assay limit of detection. 4. The effects of tampon use, douching, and specimen collection variables have not been assessed for their impact on assay detection. 5. Interference with the Aptima CV/TV assay was observed in the presence of the following substances: Tioconazole 6.5% Ointment (3% W/V, all analytes), Vaginal Moisturizing Gel (1% W/V, C spp; 5% W/V, C. glabrata; 3% W/V, TV), and Glacial Acetic Acid (5% V/V, C spp only). 6. Competitive interference may preclude detection of C. glabrata in low quantities if T. vaginalis is present in high quantities.

Clinical Reference

Workowski KA, Bachmann LH, Chan PA, Johnston CM, Muzny CA, Park I, Reno H, Zenilman JM, Bolan GA. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021 Jul 23;70(4):1-187. doi: 10.15585/mmwr.rr7004a1. PMID: 34292926; PMCID: PMC8344968.