Publications » Lancet publishes paper on the Visby Medical point-of-care PCR technology

11/23/2020Publication

Lancet publishes paper on the Visby Medical point-of-care PCR technology

A study of the performance of the Visby Medical Sexual Health Test, a single-use, point-of-care PCR device.

Authors:  Sheldon R Morris, MD; Claire C Bristow, PhD; Michael R Wierzbicki, PhD; Mark Sarno, eJD; Lenore Asbel, MD; Audrey French, MD; Charlotte A Gaydos, DrPH; Lydie Hazan, MD; Leandro Mena, MD; Purnima Madhivanan, MD; Susan Philip, MD; Saara Schwartz, MD; Constance Brown, MD; David Styers, BS; Toni Waymer, BA; Jeffrey D Klausner, MD

Published: November 23, 2020

Summary:

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.

 

See the full article here:

 

Read more articles & insights

Viewpoint

Early treatment prevents spreading the infection to others. If you are sexually active, it is important to get tested regularly at your healthcare provider, an urgent care, or other local clinic that specializes in treating these infections. Testing is the only way to know for sure if you have an STI.

Read More

Viewpoint

Visby Medical Will Exhibit at the APHL 2022 Annual Conference, a hybrid event for the public health laboratory (PHL) community.

Read More

Viewpoint

Visby Medical will exhibit at the UCA/CUCM 2022 Annual Convention. UCA is a trade and professional association in urgent care with more than 3,700 member centers representing urgent care clinical and business professionals from the United States and abroad.

Read More

Viewpoint

Visit our booth on the show floor of the NAACOS Spring 2022 Conference to learn about our revolutionary palm-sized PCR for three critical sexual health targets — chlamydia, gonorrhea, and trichomonas.

Read More