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Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study.
J Clin Microbiol. 2020 01 28; 58(2)JC

Abstract

Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for VVC, and a composite of NAAT and culture for T. vaginalis The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the Candida species group, 4% for VVC due to Candida glabrata, and 10% for T. vaginalis Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata; and 96.5% and 95.1% for T. vaginalis Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians' diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians' diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis.

Links

Authors+Show Affiliations

University of Alabama at Birmingham, Birmingham, Alabama, USA jschwebk@uabmc.edu.

Louisiana State University Health Sciences Center, New Orleans, Louisiana, USA.

Comprehensive Clinical Trials, West Palm Beach, Florida, USA.

University of Utah, Salt Lake City, Utah, USA.

Geneuity CRS, Maryville, Tennessee, USA.

Johns Hopkins University, Baltimore, Maryland, USA.

Segal Trials, Miami, Florida, USA.

Drexel University, Philadelphia, Pennsylvania, USA.

Hologic, Inc., San Diego, California, USA.

Hologic, Inc., San Diego, California, USA.

Hologic, Inc., San Diego, California, USA.

Hologic, Inc., San Diego, California, USA.

Hologic, Inc., San Diego, California, USA.

Pub Type(s)

Clinical Study

Comparative Study

Journal Article

Multicenter Study

Research Support, N.I.H., Extramural

Research Support, Non-U.S. Gov't

Validation Study

Language

eng

PubMed ID

31748322

Citation

Schwebke, Jane R., et al. "Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results From a Prospective Multicenter Clinical Study." Journal of Clinical Microbiology, vol. 58, no. 2, 2020.

Schwebke JR, Taylor SN, Ackerman R, et al. Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study. J Clin Microbiol. 2020;58(2).

Schwebke, J. R., Taylor, S. N., Ackerman, R., Schlaberg, R., Quigley, N. B., Gaydos, C. A., Chavoustie, S. E., Nyirjesy, P., Remillard, C. V., Estes, P., McKinney, B., Getman, D. K., & Clark, C. (2020). Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study. Journal of Clinical Microbiology, 58(2). https://doi.org/10.1128/JCM.01643-19

Schwebke JR, et al. Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results From a Prospective Multicenter Clinical Study. J Clin Microbiol. 2020 01 28;58(2) PubMed PMID: 31748322.

* Article titles in AMA citation format should be in sentence-case

TY - JOUR T1 - Clinical Validation of the Aptima Bacterial Vaginosis and Aptima Candida/Trichomonas Vaginitis Assays: Results from a Prospective Multicenter Clinical Study. AU - Schwebke,Jane R, AU - Taylor,Stephanie N, AU - Ackerman,Ronald, AU - Schlaberg,Robert, AU - Quigley,Neil B, AU - Gaydos,Charlotte A, AU - Chavoustie,Steven E, AU - Nyirjesy,Paul, AU - Remillard,Carmelle V, AU - Estes,Philip, AU - McKinney,Byron, AU - Getman,Damon K, AU - Clark,Craig, Y1 - 2020/01/28/ PY - 2019/10/01/received PY - 2019/11/06/accepted PY - 2019/11/22/pubmed PY - 2021/4/7/medline PY - 2019/11/22/entrez KW - Amsel criteria KW - Aptima KW - Nugent score KW - bacterial vaginosis KW - candidiasis KW - clinician’s diagnosis KW - diagnostic accuracy KW - molecular test KW - sensitivity KW - specificity KW - trichomoniasis JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 58 IS - 2 N2 - Infectious vaginitis due to bacterial vaginosis (BV), vulvovaginal candidiasis (VVC), and Trichomonas vaginalis accounts for a significant proportion of all gynecologic visits in the United States. A prospective multicenter clinical study was conducted to validate the performance of two new in vitro diagnostic transcription-mediated amplification nucleic acid amplification tests (NAATs) for diagnosis of BV, VVC, and trichomoniasis. Patient- and clinician-collected vaginal-swab samples obtained from women with symptoms of vaginitis were tested with the Aptima BV and Aptima Candida/Trichomonas vaginitis (CV/TV) assays. The results were compared to Nugent (plus Amsel for intermediate Nugent) scores for BV, Candida cultures and DNA sequencing for VVC, and a composite of NAAT and culture for T. vaginalis The prevalences of infection were similar for clinician- and patient-collected samples: 49% for BV, 29% for VVC due to the Candida species group, 4% for VVC due to Candida glabrata, and 10% for T. vaginalis Sensitivity and specificity estimates for the investigational tests in clinician-collected samples were 95.0% and 89.6%, respectively, for BV; 91.7% and 94.9% for the Candida species group; 84.7% and 99.1% for C. glabrata; and 96.5% and 95.1% for T. vaginalis Sensitivities and specificities were similar in patient-collected samples. In a secondary analysis, clinicians' diagnoses, in-clinic assessments, and investigational-assay results were compared to gold standard reference methods. Overall, the investigational assays had higher sensitivity and specificity than clinicians' diagnoses and in-clinic assessments, indicating that the investigational assays were more predictive of infection than traditional diagnostic methods. These results provide clinical-efficacy evidence for two in vitro diagnostic NAATs that can detect the main causes of vaginitis. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/31748322/Clinical_Validation_of_the_Aptima_Bacterial_Vaginosis_and_Aptima_Candida/Trichomonas_Vaginitis_Assays:_Results_from_a_Prospective_Multicenter_Clinical_Study_ DB - PRIME DP - Unbound Medicine ER -