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SureSwab® Advanced Vaginitis Plus, TMA

Test code: 10120

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, as well as Chlamydia trachomatis and Neisseria gonorrhoeae infection.

The tests included in this panel are SureSwab Advanced Bacterial Vaginosis (BV), TMA (test code 10016); SureSwab Advanced Candida Vaginitis (CV)/Trichomonas vaginalis (TV), TMA (test code 10029); and Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital (test code 11363).

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.267 Version: 0

Version 0: Effective 08/30/2022 to present