Skip to main content

Holiday schedule

Our Patient Service Centers will be closed on Wednesday, December 25, 2024 in observance of Christmas and Wednesday, January 1, 2025 in observance of New Year's Day. Have a healthy, happy holiday.

Hide
Quest Diagnostics

SureSwab® Advanced Vaginitis, TMA

Test code: 10119

This test panel uses transcription-medicated amplification (TMA) technology and is intended to aid in the diagnosis of vaginitis using clinician-collected or patient-collected vaginal swab specimens (in a clinical setting) from individuals with a clinical presentation consistent with vaginitis. This panel tests for bacterial vaginosis (BV), vulvovaginal candidiasis, and trichomoniasis.

The tests included in this panel are SureSwab Advanced Bacterial Vaginosis (BV), TMA (test code 10016) and SureSwab Advanced Candida Vaginitis (CV)/Trichomonas vaginalis (TV), TMA (test code 10029).

This in vitro nucleic acid amplification test uses real-time TMA for detection and quantitation of ribosomal RNA from bacteria associated with BV, including Lactobacillus species (L gasseri, L crispatus, L jensenii), Gardnerella vaginalis, and Atopobium vaginae. The assay reports a qualitative result for BV and does not report results for individual organisms.1

The SureSwab Advanced Bacterial Vaginosis (BV), TMA assay utilizes a different technology (ie, real-time TMA) to detect and quantify bacteria associated with BV. Results from the TMA assay are applied to a proprietary algorithm and reported as a clear, qualitative “positive” or qualitative “negative” for BV. Unlike the PCR-based test, this assay is Food and Drug Administration (FDA)-cleared and does not report results for individual organisms.

No, test results for individual organisms are not listed on the patient report and are not available. Results are reported as positive or negative for BV. Differentiating between the organisms does not affect treatment decisions, as guideline-recommended treatments are specific for BV rather than individual organisms.2 This is because BV is not caused by a single organism but is instead due to an imbalance of the vaginal flora.

This is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay utilizes real-time TMA to detect and qualitatively report results for the following organisms: Candida species group (C albicans, C tropicalis, C parapsilosis, C dubliniensis) and Candida glabrata, and TV.3

SureSwab Advanced Candida Vaginitis (CV), TMA can be ordered separately using test code 10121.

Unlike the SureSwab, Candidiasis, PCR test, the SureSwab Advanced Candida Vaginitis (CV), TMA test will not report the individual Candida species detected (C albicans, C tropicalis, C parapsilosis, C dubliniensis). In addition, SureSwab Advanced Candida Vaginitis (CV), TMA uses an FDA-cleared test, whereas the SureSwab, Candidiasis, PCR is a laboratory-developed test.

This assay also allows for the self-collection of vaginal specimens by patients in a clinical setting.

References

  1. Aptima® BV Assay. Package insert. Hologic Inc; 2021.
  2. Workowski KA, Bachmann LH, Chan PA, et al. Sexually Transmitted Infections Treatment Guidelines, 2021. MMWR Recomm Rep. 2021;70(No. RR-4):1–187. doi:10.15585/mmwr.rr7004a1
  3. Aptima® CV/TV Assay. Package insert. Hologic Inc; 2021.

 

This FAQ is provided for informational purposes only and is not intended as medical advice. Test selection and interpretation, diagnosis, and patient management decisions should be based on the clinician’s education, clinical expertise, and assessment of the patient.

 

Document FAQS.269 Version: 0

Version 0: Effective 08/30/2022 to present

Related FAQs:

SureSwab® Advanced Vaginitis Plus, TMA

SureSwab® Advanced Candida Vaginitis (CV), TMA

SureSwab® Advanced Bacterial Vaginosis (BV), TMA

Our company

Quest® is the brand name used for services offered by Quest Diagnostics Incorporated and its affiliated companies. Quest Diagnostics Incorporated and certain affiliates are CLIA-certified laboratories that provide HIPAA-covered services.  Other affiliates operated under the Quest® brand, such as Quest Consumer Inc., do not provide HIPAA-covered services. 

 

Quest®, Quest Diagnostics®, any associated logos, and all associated Quest Diagnostics registered or unregistered trademarks are the property of Quest Diagnostics. All third-party marks—® and ™—are the property of their respective owners. © 2024 Quest Diagnostics Incorporated. All rights reserved. Image content features models and is intended for illustrative purposes only.