Abstract
Screening for extra-genital Chlamydia trachomatis and Neisseria gonorrhoeae infections is a crucial component for sexually transmitted diseases management, even if at present days no commercial methods have been approved for use on pharyngeal and rectal specimens by the US FDA or have received the conformity CE marking. Here we report the analytical sensitivities of the Versant CT/GC 1.0 assay (Siemens Healthcare Diagnostics, Tarrytown, NY, USA) on rectal and pharyngeal swabs, and an evaluation about the suitability for this assay with two widely used swab collection devices (E-Swab and eNAT, Copan, Brescia, Italy). The limits of detection for rectal and pharyngeal specimens with the Versant assay were 10 copies/ml and 1.0 copies/ml, for C. trachomatis and N. gonorrhoeae, respectively. False positive results due to the presence of non-gonococcal Neisseria species were excluded when clinical rectal and pharyngeal samples containing organisms identified as N. meningitidis, N. sicca, N. flavescens and N. subflava were tested. Due to its sensitivity and specificity, the Versant assay represents a good choice for the diagnosis of chlamydial and/or gonococcal infections not only in genito-urinary samples, but also on rectal and pharyngeal swabs.
Highlights
Chlamydia trachomatis and Neisseria gonorrhoeae infections are the most common bacterial sexually transmitted infections (STIs) worldwide, representing important problems of public health [1].Anal and pharyngeal intercourse has been increasingly recognized as a component of the sexual repertoire of many couples, leading to the creation of selective high-risk networks for STIs transmission
The C. trachomatis LOD of Versant CT/GC assay on mock specimens was 10 copies/ml
The N. gonorrhoeae LOD of the Versant CT/GC assay on mock specimens was extremely low (1.0 copies/ml), with no significant differences regarding the collection devices used or the sites of collection
Summary
Chlamydia trachomatis and Neisseria gonorrhoeae infections are the most common bacterial sexually transmitted infections (STIs) worldwide, representing important problems of public health [1]. Anal and pharyngeal intercourse has been increasingly recognized as a component of the sexual repertoire of many couples, leading to the creation of selective high-risk networks for STIs transmission. Kent et al reported that 53% of chlamydial infections and 64% of gonococcal infections in a selected population of men having sex with men (MSM) were localized at PLOS ONE | DOI:10.1371/journal.pone.0120979. Diagnosis of Extra-Genital Chlamydial and Gonococcal Infections kPCR Molecular are Siemens Healthcare Diagnostics registered trademarks. The collection devices ESwab and eNAT are Copan trademarks. This does not alter the authors adherence to all the PLOS ONE policies on sharing data and materials
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