Sexually-transmitted infection (STI) - February 01, 2021

Clinical Performance of the BD CTGCTV2 assay for BD MAX™ System

Clinical Performance of the BD CTGCTV2 Assay for the BD MAX System for Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis Infections

Barbara Van Der Pol 1Edith Torres-Chavolla 2Salma Kodsi 2Charles K Cooper 2Thomas E Davis 3Kenneth H Fife 4Stephanie N Taylor 5Michael H Augenbraun 6Charlotte A Gaydos 7

February 2021


Background: Diagnostic options to combat the increasing rates of sexually transmitted infections recorded throughout the world increasingly include multiplex assays. Here we describe the estimated sensitivity and specificity of a triplex molecular assay that simultaneously detects Chlamydia trachomatis (CT), Neisseria gonorrhoeae (or gonococci [GC]), and Trichomonas vaginalis (TV).

Methods: Participants (2547 women and 1159 men) were recruited from 12 clinics in the United States. BD CTGCTV2 for BD MAX™ System assay (CTGCTV2) results were obtained from vaginal and endocervical swabs, endocervical samples in cytology medium, and female and male urine. Results were compared with infection standards that were sample type and pathogen dependent.

Results: Female specimen sensitivity estimates ranged from 92.7% to 98.4%, 92.9% to 100%, and 86.6% to 100% for CT, GC and TV, respectively. Male urine sensitivity estimates were 96.7%, 99.2%, and 97.9% for CT, GC, and TV, respectively. Specificity estimates were >98.7% for all sample types.

Conclusions: BD CTGCTV2 performed well using a variety of sample types. As a true triplex assay, performed using a benchtop instrument, BD CTGCTV2 may be useful in settings where no testing is currently performed and in settings, such as reference laboratories, where testing turnaround time may be several days. Use of this assay at local laboratories may result in greater access to testing and a shorter time to result, which are important steps for improving our ability to combat sexually transmitted infections.

Copyright © 2020 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Sexually Transmitted Diseases Association.


Access the full publication


Conflict of interest statement

Conflict of Interest and Sources of Funding: B.V.D.P. received institutional research support, honorarium, or consulting fees from Becton, Dickinson and Company; Atlas Genetics; Beckman Coulter; Click Diagnostics; Hologic; Luminex; Roche; and SpeeDx. C.A.G. received institutional research support, honorarium, or consulting fees from Becton, Dickinson and Company; Atlas Genetics; Beckman Coulter; Click Diagnostics; Hologic; Quidel; and SpeeDx. E.T.-C., S.K., and C.K.C. are employees of the study sponsor. T.E.D., K.H.F., S.N.T., and M.H.A. have no conflicts of interest.


By reading this content you are acknowledging our forward looking statement.

Why join BD MAX™ Club?

Connect with professionals from around the world BD MAX™ Club members represent a community of professionals in infectious diseases and molecular diagnostics. With regional meet-ups and live webinars from global experts, expand your laboratory’s network and collaborate with worldwide colleagues.

Tailored medical and technical expertise Whether you need compelling scientific research or tutorials for troubleshooting on the BD MAX™ System, BD MAX™ Club is here to accompany your molecular diagnostics journey. Log in to your BD MAX™ Club account anywhere, anytime to access our information database.

Exclusive members’ perks BD MAX™ Club membership unlocks doors to exclusive webinars and collaboration with industry leading experts. Engage with your colleagues in the molecular community and exchange with the BD research and development team.

More scientific content

Forward Looking Statement

The information included on this website and other information provided from time to time through webcasts, conference calls, securities analyst meetings, road show presentations, investor conferences, newsletters and similar events and communications contains forward-looking statements (as defined under Federal securities laws) based on current expectations and assumptions that involve risks and uncertainties. If the risks or uncertainties ever materialize or the assumptions prove incorrect, the results of BD may differ materially from those expressed or implied by such forward-looking statements and assumptions. Forward-looking statements may be identified by the use of words such as “plan,” “expect,” “believe,” “intend,” “will,” “may,” “anticipate,” “estimate” and other words of similar meaning in conjunction with, among other things, discussions of future operations and financial performance (including volume growth, pricing, sales and earnings per share growth, and cash flows) and statements regarding our strategy for growth, future product development, regulatory approvals, competitive position and expenditures.

All such statements are based upon current expectations of BD and involve a number of business risks and uncertainties. Actual results could vary materially from anticipated results described, implied or projected in any forward-looking statement. Many of these risks and uncertainties are beyond the company’s control. For a discussion of certain factors that could cause our actual results to differ from our expectations in any forward-looking statements see our latest Annual Report on Form 10-K and other filings with the SEC. BD expressly disclaims any undertaking to update or revise any forward looking statements set forth herein to reflect events or circumstances after the date hereof, except as required by applicable law or regulation.