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. 2023 Aug 17;99(6):416-419.
doi: 10.1136/sextrans-2022-055576.

PivNG primers and probes set used in the cobas omni Utility Channel is a reliable supplemental test for detection of Neisseria gonorrhoeae in oropharyngeal, urogenital and rectal specimens collected in cobas PCR Media

Mark Hopkins  1   2 , Rodney Arcenas  3 , Xose Couto-Parada  2 , Michael Lewinski  3 , Merlin Njoya  3 , Deva Perinpanathan  2 , Rizwaan Sheriff  2 , Avneet Hansra  3 , Selena Singh  2
Affiliations

PivNG primers and probes set used in the cobas omni Utility Channel is a reliable supplemental test for detection of Neisseria gonorrhoeae in oropharyngeal, urogenital and rectal specimens collected in cobas PCR Media

Mark Hopkins et al. Sex Transm Infect. .

Abstract

Objective: To evaluate the clinical performance of the novel PivNG primers and probes set (PivNG test) used in the cobas omni Utility Channel for supplemental testing of Neisseria gonorrhoeae (NG).

Methods: Oropharyngeal, urogenital and rectal samples were self-collected during routine testing at Barts Health sexual health clinics, London, UK. Samples were tested by the cobas CT/NG test and PivNG cobas omni Utility Channel test on cobas 6800/8800 Systems. Supplemental testing was carried out with the Xpert CT/NG test. PivNG overall percent agreements, positive percent agreements (PPAs)/negative percent agreements (NPAs) and positive/negative predictive values were calculated for each sample type. Microscopy and/or culture data were included for a randomised subset of concordant/discordant results, and a composite reference standard (cobas CT/NG, Xpert CT/NG and culture results) adjusted for partial verification bias was used to determine PivNG PPA and NPA.

Results: Of 447 evaluable samples with valid results from all three assays (cobas CT/NG, PivNG and Xpert CT/NG), 288 (64.4%) were NG-positive by both PivNG and cobas CT/NG; 117 (26.2%) were NG-negative in both tests; and 42 (9.4%) had discordant results (with NG-negative supplementary Xpert) CT/NG results in 40/42 instances). Of 19 PivNG/Xpert CT/NG-discordant samples, 11 were confirmed NG-positive by microscopy and/or culture results. PivNG PPA and NPA were 100% and 91% for oropharyngeal swabs, 100% and 100% for vaginal swabs, 100% and 100% for male urine samples, and 100% and 97% for rectal swabs, respectively, compared with the partially adjusted composite reference standard.

Conclusions: PivNG is a reliable supplementary test with high sensitivity for confirming NG infection when used in conjunction with the cobas CT/NG test and samples collected in cobas PCR Media. Moreover, the PivNG test offers a convenient, high-throughput solution for supplemental NG testing of various sample types, with the potential to reduce the number of indeterminate reports.

Keywords: Bacterial Infections; Molecular Diagnostic Techniques; NEISSERIA GONORRHOEAE; Nucleic Acid Amplification Techniques; Polymerase Chain Reaction.

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Conflict of interest statement

Competing interests: MH received support from Roche Molecular Systems for study protocol costs and is a member of the speaker's bureau of Roche Molecular Systems. XCP received support from Roche Diagnostics to attend past meetings not related to this study. DP, RS and SS have nothing to disclose. RA, ML and AH are employees of Roche Molecular Systems and report receiving stocks and stock options from Roche. MN is an employee of Roche Molecular Systems.

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