TY - JOUR
T1 - Performance of a single-use, rapid, point-of-care PCR device for the detection of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis
T2 - a cross-sectional study
AU - Morris, Sheldon R.
AU - Bristow, Claire C.
AU - Wierzbicki, Michael R.
AU - Sarno, Mark
AU - Asbel, Lenore
AU - French, Audrey
AU - Gaydos, Charlotte A.
AU - Hazan, Lydie
AU - Mena, Leandro
AU - Madhivanan, Purnima
AU - Philip, Susan
AU - Schwartz, Saara
AU - Brown, Constance
AU - Styers, David
AU - Waymer, Toni
AU - Klausner, Jeffrey D.
N1 - Funding Information:
SRM, CBB, DS, LH, CB, SS, CAG, TW, AF, SP, MS, LM, and JDK received funds via grants or contracts from the NIH. SP has received funding from University of California San Francisco. MS has received personal fees from Visby Medical. CAG has received funding support from Cepheid, SpeeDx, Binx Health, Becton Dickinson, and Hologic. LM has received grant funding from Roche Molecular, Evofem, Janssen Pharmaceutical, Prosoft Clinical, GlaxoSmithKlein, and SpeeDx.
Funding Information:
Overall support for the STAR Sexually Transmitted Infections Clinical Trials Group and study sites was provided by the National Institute of Allergy and Infectious Diseases Division of Microbiology and Infectious Diseases (HHSN272201300014I and HHSN27200010). The contents of this publication are solely the responsibility of the authors and do not necessarily represent the official views of the NIH. We wish to also thank all collaborators on this project, especially Paula Walker and others at Visby Medical, and Chris Hemphill and Garrick Osterhold at the Molecular Testing Labs and Axis Clinical Trial sites. The authors acknowledge the scientific and programmatic guidance of Peter Wolff and Carolyn Deal of the NIH Division of Microbiology and Infectious Diseases.
Funding Information:
JDK has received support from Danaher, Cepheid, and Hologic. SRM held financial interests in Pfizer, Bristol Myers Squibb, Geron, and Forty Seven; and has received grant funding from Gilead, Merck, the California Institute of Regenerative Medicine, and the California HIV/AIDS Research Program. All other authors declare no competing interests.
Publisher Copyright:
© 2021 Elsevier Ltd
PY - 2021/5
Y1 - 2021/5
N2 - Background: Timely detection and treatment are important for the control of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The objective of this study was to measure the performance of the Visby Medical Sexual Health Test, a single-use, point-of-care PCR device. Methods: Women aged 14 years and older who presented consecutively to ten clinical sites across seven US states were enrolled for a cross-sectional, single-visit study. Patients who consented to participate, and who had not used any exclusionary products in the genital area in the previous 48 h, provided self-collected vaginal swabs for testing with the investigational device. Untrained operators received the specimens and ran the device using the guide provided. Specimens had to be run within 2 h of collection to be considered valid. For comparison, patient-infected status was derived by testing clinician-collected vaginal specimens with the Hologic Aptima Combo 2 Assay and Aptima Trichomonas vaginalis Assay, as well as the BD ProbeTec CT/GC Qx Amplified DNA Assay and BD ProbeTec Trichomonas vaginalis Qx Assay. If the results of those assays did not match, the BD MAX CT/GC/TV was used as a tiebreaker. The primary outcomes were the sensitivity and specificity of the investigational device for the detection of C trachomatis, N gonorrhoeae, and T vaginalis compared with patient-infected status. Findings: Between Feb 25, 2019, and Jan 6, 2020, 1585 participants aged between 14 years and 80 years (mean 34·8 [SD 14·2]) were enrolled. 1555 participants had tests run with the investigational device, of whom 1532 (98·5%) had a valid result on either the first or repeat test. Among the patients with evaluable results (including a determinate patient-infected status), the device had a sensitivity of 97·6% (95% CI 93·2–99·2) and specificity of 98·3% (97·5–98·9) for C trachomatis (n=1457), sensitivity of 97·4% (86·5–99·5) and specificity of 99·4% (98·9–99·7) for N gonorrhoeae (n=1468), and sensitivity of 99·2% (95·5–99·9) and specificity of 96·9% (95·8–97·7) for T vaginalis (n=1449). Interpretation: This innovative, rapid, easy-to-use, single-use, point-of-care device to detect C trachomatis, N gonorrhoeae, and T vaginalis infections showed excellent sensitivity and specificity, and could represent an important advance in the development of rapid diagnostics for sexually transmitted infections and other infectious diseases. Funding: Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.
AB - Background: Timely detection and treatment are important for the control of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis. The objective of this study was to measure the performance of the Visby Medical Sexual Health Test, a single-use, point-of-care PCR device. Methods: Women aged 14 years and older who presented consecutively to ten clinical sites across seven US states were enrolled for a cross-sectional, single-visit study. Patients who consented to participate, and who had not used any exclusionary products in the genital area in the previous 48 h, provided self-collected vaginal swabs for testing with the investigational device. Untrained operators received the specimens and ran the device using the guide provided. Specimens had to be run within 2 h of collection to be considered valid. For comparison, patient-infected status was derived by testing clinician-collected vaginal specimens with the Hologic Aptima Combo 2 Assay and Aptima Trichomonas vaginalis Assay, as well as the BD ProbeTec CT/GC Qx Amplified DNA Assay and BD ProbeTec Trichomonas vaginalis Qx Assay. If the results of those assays did not match, the BD MAX CT/GC/TV was used as a tiebreaker. The primary outcomes were the sensitivity and specificity of the investigational device for the detection of C trachomatis, N gonorrhoeae, and T vaginalis compared with patient-infected status. Findings: Between Feb 25, 2019, and Jan 6, 2020, 1585 participants aged between 14 years and 80 years (mean 34·8 [SD 14·2]) were enrolled. 1555 participants had tests run with the investigational device, of whom 1532 (98·5%) had a valid result on either the first or repeat test. Among the patients with evaluable results (including a determinate patient-infected status), the device had a sensitivity of 97·6% (95% CI 93·2–99·2) and specificity of 98·3% (97·5–98·9) for C trachomatis (n=1457), sensitivity of 97·4% (86·5–99·5) and specificity of 99·4% (98·9–99·7) for N gonorrhoeae (n=1468), and sensitivity of 99·2% (95·5–99·9) and specificity of 96·9% (95·8–97·7) for T vaginalis (n=1449). Interpretation: This innovative, rapid, easy-to-use, single-use, point-of-care device to detect C trachomatis, N gonorrhoeae, and T vaginalis infections showed excellent sensitivity and specificity, and could represent an important advance in the development of rapid diagnostics for sexually transmitted infections and other infectious diseases. Funding: Division of Microbiology and Infectious Diseases, National Institute of Allergy and Infectious Diseases.
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U2 - 10.1016/S1473-3099(20)30734-9
DO - 10.1016/S1473-3099(20)30734-9
M3 - Article
C2 - 33242473
AN - SCOPUS:85097466151
SN - 1473-3099
VL - 21
SP - 668
EP - 676
JO - The Lancet Infectious Diseases
JF - The Lancet Infectious Diseases
IS - 5
ER -