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. 2024 Dec 13;73(4):529–534. doi: 10.33073/pjm-2024-045

Advantages of Syndromic Diagnostics: Detection of the Pathogens Causing Urethritis/Cervicitis with the STI CNM Real-Time PCR Kit from Vitro S.A.

Miguel Ángel Castaño López 1, Héctor Toledo Porteros 1,2,✉, Alberto De La Iglesia Salgado 1, Josefa Vazquez Medel 1, Inmaculada García Borrero 1
PMCID: PMC11639385  PMID: 39670640

Abstract

The STI CNM Real-Time PCR Kit from Vitro S.A. (Spain) demonstrates high sensitivity and specificity, is cost-effective, and can detect the three main etiological agents of urethritis/cervicitis in a single multiplex PCR. Sexually transmitted infections (STIs) are a significant public health problem and a significant burden of morbidity and mortality in hospitals. The World Health Organization (WHO) estimates the number of daily infections to be 1 million. Currently, the number of infections and antimicrobial-resistant strains is rising. A rapid and accurate etiologic diagnosis is critical to solving this problem. In this study, we compared the STI CNM Real-Time PCR Kit using the Xpert® CT/NG technique (Cepheid®, USA) as Gold Standard for the diagnosis of Chlamydia trachomatis and Neisseria gonorrhoeae and EasyNAT® MG (Ustar Biotechnologies (Hangzhou) Ltd., China) as Gold Standard for the diagnosis of Mycoplasma genitalium infection. Regarding C. trachomatis and N. gonorrhoeae, out of 200 samples, there was a match in 199 cases, with only one positive sample not being detected by the STI CNM Real-Time PCR Kit. This results in a sensitivity of 96% and a specificity of 100% for this kit. Diagnosing M. genitalium infection, out of 200 samples, the STI CNM Real-Time PCR Kit correctly detected all negative and positive samples, with 100% agreement compared to the reference technique. In summary, the STI assay has a very high sensitivity and specificity, comparable to other commercial diagnostic kits. Furthermore, it has the advantage of bundling the detection of the three main bacterial agents of urethritis/cervicitis, resulting in better cost efficiency.

Keywords: STI, syndromic diagnostics, Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae

Introduction

Sexually transmitted infections (STIs) represent a significant public health challenge due to their high prevalence and potential to cause serious short- and long-term consequences. More than 30 pathogens, including bacteria, viruses, and parasites, are transmitted primarily through sexual contact or vertical transmission (Jansen et al. 2020; WHO 2022). Among these, Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium are the most common bacterial STIs, each contributing to morbidity, reproductive complications, and facilitating the transmission of HIV (Jensen et al. 2022; Tuddenham et al. 2022).

The World Health Organization (WHO) estimates that 1 million people acquire a new STI daily, underscoring these infections’ global burden (WHO 2021; Sinka 2024). While syndromic management has traditionally been the standard approach, relying on clinical symptoms to guide treatment (WHO 2003), this method has several limitations. Infections such as C. trachomatis, N. gonorrhoeae, and M. genitalium frequently present with asymptomatic or non-specific symptoms, particularly in women and HIV-positive populations, making syndromic management insufficient for accurate detection (Farfour et al. 2021). To address this, molecular diagnostic techniques, particularly nucleic acid amplification tests (NAATs) like realtime PCR and multiplex PCR, have gained prominence for their sensitivity, specificity, and ability to screen asymptomatic individuals at risk (Unemo et al. 2017; Levy et al. 2019; de Vries et al. 2019).

C. trachomatis remains the most common bacterial STI globally, with young adults being particularly vulnerable (Lane and Decker 2016). N. gonorrhoeae, however, poses an additional challenge due to increasing antibiotic resistance, which threatens to render it untreatable shortly (Unemo et al. 2020). Likewise, M. genitalium is gaining recognition for its high prevalence and alarming resistance to macrolides, necessitating advanced diagnostic tools that also detect resistance mutations (Horner et al. 2019; Gnanadurai and Fifer 2020).

Molecular diagnostics, particularly NAATs, have revolutionized the detection of these pathogens. Techniques such as real-time PCR and multiplex PCR allow for the simultaneous detection of multiple STI pathogens in a single test, which is a major advance over traditional methods like bacterial culture or immunoassays. These molecular tests improve diagnostic accuracy, reduce turnaround times, and enable earlier treatment interventions (de Vries et al. 2019; Unemo et al. 2019). However, their cost remains a significant barrier in many settings, particularly in low-resource regions where STIs are highly prevalent (Saweri et al. 2019; Mallik et al. 2020).

While the high sensitivity and specificity of these tests offer significant benefits in terms of public health and long-term cost savings, the initial investment required for implementing molecular diagnostics can be prohibitive. Therefore, a thorough evaluation of the cost-benefit ratio is essential to determine the most appropriate diagnostic approach in various clinical settings. Multiplex PCR techniques offer several advantages over conventional PCR for the diagnosis of sexually transmitted infections (STIs). One of the main benefits is the ability to simultaneously detect multiple pathogens in a single assay, which significantly improves diagnostic efficiency, especially for complex infections where multiple causative agents may be involved. These molecular tests improve diagnostic accuracy, reduce turnaround times, and enable earlier treatment interventions (Ramanan et al. 2017; Dien Bard and McElvania 2020; Naeem et al. 2021). Studies have shown that multiplex PCR can deliver highly sensitive and specific results for common STI pathogens, such as C. trachomatis, N. gonorrhoeae, and M. genitalium, compared to traditional PCR methods, which usually target a single pathogen at a time (Medhi et al. 2024).

This study aims to compare the performance of the STI CNM Real-Time PCR Kit (Vitro S.A, Spain) in the diagnosis of C. trachomatis, N. gonorrhoeae, and M. geni-talium by evaluating its sensitivity, specificity, and level of concordance with two other commercial methods: the Xpert® CT/NG Kit (Cepheid®, USA) and EasyNAT® MG (Ustar Biotechnologies (Hangzhou) Ltd., China).

Experimental

Materials and Methods

Two commercial RT-PCR kits were compared for the detection of C. trachomatis, N. gonorrhoeae, and M. genitalium, based on the criteria of the Clinical and Laboratory Standards Institute (CLSI 2008).

The study was conducted at the Infanta Elena Hospital in Huelva, Andalusia, Spain, in 2023. A total of 200 samples were collected from different anatomical sites from patients attending our hospital’s infectious diseases clinic for the determination of C. trachomatis, N. gonorrhoeae, and M. genitalium. The samples were tested simultaneously using the different methods described.

The determinations were performed with the Xpert® CT/NG Kit; the commercial STI CNM Real-Time PCR Kit, determined on a QuantStudio™ 5 Real-Time PCR System (Applied Biosystems™, Thermo Fisher Scientific, Inc., USA) after extraction on a Nextractor® NX-48S (Genolution Inc., Republic of Korea); and the EasyNAT® MG on an EasyNAT® 2.0 device. The primers and probes of the Xpert® CT/NG Kit recognize chromosomal sequences of C. trachomatis (CT1: one target) and N. gonorrhoeae (NG2 and NG4: two different targets). The STI CNM Real-Time PCR Kit uses fluorescent primers and probes for the target genes Opal (N. gonorrhoeae), cryptic plasmid (C. trachomatis) and MgPa (M. genitalium). The Xpert® CT/NG Kit measures C. trachomatis and N. gonor-rhoeae in a single step, while the STI CNM Real-Time PCR Kit also measures M. genitalium. The EasyNAT® MG only measures M. genitalium in a single step.

All tests were performed and analyzed according to the manufacturer’s instructions. Relevant guidelines and regulations were followed for all methods. Hospital Infanta Elena Ethics Committee waived the need for ethical approval and informed consent.

Cohen’s kappa coefficient and Spearman’s correlation were used for the statistical analyses to assess the agreement level. Diagnostic test efficiency indicators (sensitivity, specificity, positive and negative predictive values) were also utilized. These indicators were introduced by Yerushalmy (1947) and are widely used today to evaluate the efficiency of a diagnostic test compared to a reference standard.

Results

A total of 200 samples were collected from 90 patients (14 women and 76 men), whose ages ranged from 18 to 79, with a mean age of 35 and a median age of 37 (Table SI).

Below are the results obtained with the different diagnostic techniques. Table I shows the results obtained with the Xpert® CT/NG system for C. trachomatis and N. gonorrhoeae, a method of proven reliability (Xie et al. 2020; Cordioli et al. 2024). We consider this method to be the reference method as it has been recommended by the WHO (Jacobsson et al. 2018). In addition, the results for M. genitalium obtained with the EasyNAT® MG are shown.

Table I.

Results obtained with Xpert CT/NG® and EasyNAT MG® from Ustar (MG).

Chlamydia trachomatis Neisseria gonorrhoeae Mycoplasma genitalium
NEG POS NEG POS NEG POS
Pharyngeal swab (34.0%) 65 3 64 4 65 3
Rectal swab (31.5%) 57 6 62 1 57 6
Urethral swab (25.0%) 44 6 48 2 48 2
Endocervical swab (5.5%) 10 1 11 0 11 0
Initial urine (4.0%) 8 0 8 0 0 8
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A total of 41 samples (20.5%) tested positive. 8% were positive for C. trachomatis, 3.5% for N. gonorrhoeae and 9.5% for M. genitalium. One sample was positive for both C. trachomatis and M. genitalium. Regarding anatomical localization, C. trachomatis showed a higher prevalence in urethral and rectal swabs, while N. gonorrhoeae was more common in pharyngeal swabs. The remarkably high positivity rate (100%) for M. genitalium in urine is surprising and can be explained by the fact that in our hospital, this sample is only sent to the laboratory in patients with a high suspicion of persistent urethritis after C. trachomatis/N. gonorrhoeae had previously been excluded. Only one sample (C. trachomatis) tested positive in the endocervical smear, although the small number of samples of this type analyzed does not allow for conclusive results.

Comparative results (Xpert® CT/NG vs. STI CNM Real-Time PCR Kit). Table II is a concordance table between the two techniques. As shown, the agreement between the two is almost complete, both for positive and negative samples. The only positive sample that the STI CNM Real Time PCR Kit failed to detect tested positive.

Table II.

Concordance table between both techniques. Below, statistical parameters are shown.

Xpert® CT/NG
POS NEG
STI CNM Real Time POS 29 0
PCR Kit NEG 1* 170
Sensitivity: 96%
Specificity: 100%
Positive predictive value: 100%
Negative predictive value: 99%
Kappa index: 0,98
Standard error: 0,071
C.I. 95%: 0,84–1,10
Concordance: very good
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1

* Detailed analysis of this single discordant sample showed a slight amplification around cycle 39, suggesting that the sensitivity of the technique would be increased at a higher threshold.

Comparative results (EasyNAT® MG vs. STI CNM Real-Time PCR Kit). Table III shows the results of the comparison between the two techniques used to detect M. genitalium. As shown, there is complete agreement between the two.

Table III.

Concordance table between both techniques. Below, statistical parameters are shown.

EasyNAT® MG
POS NEG
STI CNM Real Time POS 19 0
PCR Kit NEG 0 181
Sensitivity: 100% (IC: 90,6–100%)
Specificity: 100% (IC: 96,9–100%)
Positive predictive value: 100% (IC: 83,1–100%)
Negative predictive value: 100% (IC: 98,3–100%)
Kappa index: 1
Standard error: 0,02
C.I. 95%: 0,93–1,01
Concordance: excellent
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Discussion

Ever since the American CDC recommended it in 2014 (Papp et al. 2014), nucleic acid amplification techniques have gained significant popularity in STI diagnostics. These techniques are favored due to their high sensitivity, specificity, and quick turnaround time for results. Over the years, several diagnostic kits have been introduced, improving the accuracy of STI diagnosis, streamlining laboratory processes, and enhancing the management of these infections. Currently, numerous studies validate the diagnostic efficacy of many of these tools (Bristow et al. 2017; Levy et al. 2019; Herrmann and Malm 2021; Tuddenham et al. 2022. These studies consistently demonstrate sensitivity and specificity results that are sufficiently high to warrant their routine use, replacing traditional culture and serology-based systems.

The efficacy of molecular techniques for diagnosing CT and NG has been extensively tested, and numerous commercial solutions offer high sensitivity and specificity both in the genital (Papp et al. 2014; Caruso et al. 2021) and extragenital infection (Cosentino et al. 2017; Cordioli et al. 2024). Our study aligns with this growing trend by showcasing that the STI CNM Real-Time PCR Kit from Vitro S.A. exhibits comparable sensitivity and specificity to other widely used techniques, such as the Xpert® CT/NG Kit, for diagnosing C. trachomatis and N. gonorrhoeae (Xie et al. 2020; Cordioli et al. 2024).

M. genitalium is accountable for a significant proportion of non-chlamydial and non-gonococcal urethritis in men, ranging from 10% to 35%, and cervicitis in women, ranging from 10% to 25% (Horner et al. 2019; Gnanadurai and Fifer 2020). In the past, identifying infections caused by this microorganism was challenging due to the difficulties associated with isolating it in culture. However, with the introduction of molecular techniques, the diagnosis of M. genitalium infections has improved. The European Academy of Dermatology and Venereology now recommends nucleic acid amplification techniques as the most effective diagnostic method and emphasizes the importance of considering this microorganism in the differential diagnosis of urethritis and cervicitis (Jensen et al. 2022). Despite this recommendation, limited commercial techniques are available that include M. genitalium in their diagnostic panels.

Nevertheless, the approval of the first molecular technique for its detection by the FDA (Shipitsyna and Unemo 2020) has led to several studies demonstrating the high sensitivity and specificity of these techniques (Lee et al. 2012; Le Roy et al. 2012; 2014; Vandepitte et al. 2014; Kirkconnell et al. 2019; Shipitsyna and Unemo 2020; Salazar and García 2022). In our study, we compared the STI CNM Real-Time PCR Kit from Vitro S.A. with the EasyNAT® MG from Ustar Biotechnologies (Hangzhou) Ltd. and found a strong agreement between both techniques, as well as high sensitivity and specificity. Therefore, like the recommendations for C. trachomatis and N. gonorrhoeae, we support the routine use of the STI CNM Real-Time PCR Kit in clinical laboratories.

However, the leading interest for the clinical laboratory in the STI assay from Vitro S.A. is not solely based on its commendable sensitivity and specificity. Instead, its value lies in identifying the three primary causative agents of urethritis/cervicitis through a single multiplex PCR reaction. This feature makes it an ideal candidate for integration into syndromic diagnostic strategies, which have proven to be cost-effective by enhancing patient management, optimizing antibiotic usage, preventing new infections, and streamlining overall laboratory operations (Ramanan et al. 2017; Dumkow et al. 2021; Karellis et al. 2022). Furthermore, in our laboratory, the implementation of this kit has resulted in a remarkable 76.5% reduction in economic costs for these analyses, reducing the expense from €68 to a mere €16 per test, which underscores its potential for improving cost-effectiveness in STI diagnostics.

The main limitation of our study was that it was carried out on routine clinical samples received in our laboratory without any specific recruitment of patients beyond selecting those with a suspected diagnosis of STI. This also meant that we did not reach a sufficiently high number of samples of each type analyzed. Therefore, although our results are in line with those of previous studies, which indicate that there are no significant differences in sensitivity or specificity based on the anatomical location of the sample (Bristow et al. 2017; Jansen et al. 2020; Herrmann and Malm 2021), it is essential to exercise caution when concluding due to the limited number of positive cases in specific anatomical locations.

To summarize, the STI CNM Real-Time PCR Kit developed by Vitro S.A. proves to be extremely valuable in identifying N. gonorrhoeae, C. trachomatis, and M. genitalium in various clinical samples, including urine, urethral, rectal, vaginal, endocervical and pharyngeal swabs. One of its key advantages is adopting a syndromic diagnostic approach, streamlining the sample processing procedure in the laboratory, expediting result delivery, and optimizing resource utilization. With its remarkable sensitivity and specificity, this kit is highly recommended for routine use in clinical laboratories as it consistently provides reliable results, thereby facilitating the effective management of sexually transmitted infections. Moreover, the kit’s capability to simultaneously detect the three primary causative agents of ure-thritis/cervicitis through a single multiplex PCR reaction, coupled with the substantial reduction in economic costs observed in our laboratory, further underscores its practicality and convenience in the clinical setting.

Supplementary Material

Supplementary Material Details

pjm-2024-045_sm.pdf (71.9KB, pdf)

Footnotes

Availability of data and material

The datasets used and/or analyzed during the current study available from the corresponding author on reasonable request.

Ethical statement

The need for ethical approval and informed consent was waived by Hospital Infanta Elena Ethics Committe.

Author contributions

All authors contributed to the study conception and design. Material preparation, data collection and analysis were performed by Miguel Ángel Castaño López, Inmaculada García Borrero and Josefa Vazquez Medel. The first draft of the manuscript was written by Héctor Toledo Porteros and Alberto De La Iglesia Salgado. All authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Conflict of interest

The authors do not report any financial or personal connections with other persons or organizations, which might negatively affect the contents of this publication and/or claim authorship rights to this publication.

Literature

  1. Bristow CC, McGrath MR, Cohen AC, Anderson LJ, Gordon KK, Klausner JD. Comparative evaluation of 2 nucleic acid amplification tests for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae at extragenital sites Sex Transm Dis 2017 NaN44(7):398. doi: 10.1097/olq.0000000000000627. . . ; ( ): –. . [DOI] [PMC free article] [PubMed] [Google Scholar]
  2. Caruso G, Giammanco A, Virruso R, Fasciana T. Current and future trends in the laboratory diagnosis of sexually transmitted infections Int J Environ Res Public Health 2021 NaN18(3):1038. doi: 10.3390/ijerph18031038. . . ; ( ): . [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. CLSI User protocol for evaluation of qualitative test performance; approved guideline – second edition. CLSI document EP12-A2. Wayne (USA): Clinical and Laboratory Standards Institute; 2008. . . : ; . [Google Scholar]
  4. Cordioli M, Gios L, Erbogasto A, Mirandola M, Sandri A, Padovese V, Caceres C, Vargas S, Blondeel K, Silva R, et al. ProSPeRo Network Clinic-based evaluation of the dual Xpert CT/NG assay on the GeneXpert System for screening for extragenital chlamydial and gonococcal infections amongst men who have sex with men BMC Infect Dis 2024 NaN24(Suppl 1):224. doi: 10.1186/s12879-024-09042-4. . . . ; ( ): . [DOI] [PMC free article] [PubMed] [Google Scholar]
  5. Cosentino LA, Danby CS, Rabe LK, Macio I, Meyn LA, Wiesenfeld HC, Hillier SL. Use of nucleic acid amplification testing for diagnosis of extragenital sexually transmitted infections J Clin Microbiol 2017 NaN55(9):2801. doi: 10.1128/jcm.00616-17. . . ; ( ): –. . [DOI] [PMC free article] [PubMed] [Google Scholar]
  6. de Vries HJC, de Barbeyrac B, de Vrieze NHN, Viset JD, White JA, Vall-Mayans M, Unemo M. 2019 European guideline on the management of lymphogranuloma venereum J Eur Acad Dermatol Venereol 2019 NaN33(10):1821. doi: 10.1111/jdv.15729. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  7. Dien Bard J, McElvania E. Panels and syndromic testing in clinical microbiology Clin Lab Med 2020 NaN40(4):393. doi: 10.1016/j.cll.2020.08.001. . . ; ( ): –. . [DOI] [PMC free article] [PubMed] [Google Scholar]
  8. Dumkow LE, Worden LJ, Rao SN. Syndromic diagnostic testing: A new way to approach patient care in the treatment of infectious diseases J Antimicrob Chemother 2021 NaN76(Suppl 3):iii4. doi: 10.1093/jac/dkab245. . . ; ( ): –. . [DOI] [PMC free article] [PubMed] [Google Scholar]
  9. Farfour E, Dimi S, Chassany O, Fouéré S, Valin N, Timsit J, Ghosn J, Duvivier C, Duracinsky M, Zucman D, DRIVER study group Trends in asymptomatic STI among HIV-positive MSM and lessons for systematic screening PLoS One 2021 NaN16(6):e0250557. doi: 10.1371/journal.pone.0250557. . . . ; ( ): . [DOI] [PMC free article] [PubMed] [Google Scholar]
  10. Gnanadurai R, Fifer H. Mycoplasma genitalium: A review Microbiology 2020 NaN166(1):21. doi: 10.1099/mic.0.000830. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  11. Herrmann B, Malm K. Comparison between Abbott m2000 RealTime and Alinity m STI systems for detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium Eur J Clin Microbiol Infect Dis 2021 NaN40(10):2217. doi: 10.1007/s10096-020-04135-9. . . ; ( ): –. . [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Horner P, Taylor-Robinson D, Pallecaros A, Monnickendam A. Testing for genital mycoplasmas and ureaplasmas Int J STD AIDS 2019 NaN30(3):310. doi: 10.1177/0956462418820400. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  13. Jacobsson S, Boiko I, Golparian D, Blondeel K, Kiarie J, Toskin I, Peeling RW, Unemo M. WHO laboratory validation of Xpert® CT/NG and Xpert® TV on the GeneXpert system verifies high performances APMIS 2018 NaN126(12):907. doi: 10.1111/apm.12902. . . ; ( ): –. . [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Jansen K, Steffen G, Potthoff A, Schuppe AK, Beer D, Jessen H, Scholten S, Spornraft-Ragaller P, Bremer V, Tiemann C, MSM Screening Study group STI in times of PrEP: High prevalence of chlamydia, gonorrhea, and mycoplasma at different anatomic sites in men who have sex with men in Germany BMC Infect Dis 2020 NaN20(1):110. doi: 10.1186/s12879-020-4831-4. . . . ; ( ): . [DOI] [PMC free article] [PubMed] [Google Scholar]
  15. Jensen JS, Cusini M, Gomberg M, Moi H, Wilson J, Unemo M. 2021 European guideline on the management of Mycoplasma geni-talium infections J Eur Acad Dermatol Venereol 2022 NaN36(5):641. doi: 10.1111/jdv.17972. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  16. Karellis A, Naeem F, Nair S, Mallya SD, Routy JP, Gahagan J, Yansouni CP, Kim J, Pai NP. Multiplexed rapid technologies for sexually transmitted infections: A systematic review Lancet Microbe 2022 NaN3(4):e303. doi: 10.1016/S2666-5247(21)00191-9. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  17. Kirkconnell B, Weinbaum B, Santos K, Le Nguyen T, Vinluan B, Astete S, Wood GE, Totten PA, Getman DK. Design and validation of transcription-mediated-amplification nucleic acid amplification tests for Mycoplasma genitalium J Clin Microbiol 2019 NaN57(8):e00264. doi: 10.1128/jcm.00264-19. . . ; ( ): –. . [DOI] [PMC free article] [PubMed] [Google Scholar]
  18. Lane AB, Decker CF. Chlamydia trachomatis infections Dis Mon 2016 NaN62(8):269. doi: 10.1016/j.disamonth.2016.03.010. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  19. Le Roy C, Le Hen I, Clerc M, Arfel V, Normandin F, Bébéar C, de Barbeyrac B. The first performance report for the Bio-Rad Dx CT/NG/MG assay for simultaneous detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium in urogenital samples J Microbiol Methods 2012 NaN89(3):193. doi: 10.1016/j.mimet.2012.03.009. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  20. Le Roy C, Pereyre S, Bébéar C. Evaluation of two commercial real-time PCR assays for detection of Mycoplasma genitalium in urogenital specimens J Clin Microbiol 2014 NaN52(3):971. doi: 10.1128/jcm.02567-13. . . ; ( ): –. . [DOI] [PMC free article] [PubMed] [Google Scholar]
  21. Lee SJ, Park DC, Lee DS, Choe HS, Cho YH. Evaluation of Seeplex® STD6 ACE Detection kit for the diagnosis of six bacterial sexually transmitted infections J Infect Chemother 2012 NaN18(4):494. doi: 10.1007/s10156-011-0362-7. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  22. Levy SB, Gunta J, Edemekong P. Screening for sexually transmitted diseases Prim Care 2019 NaN46(1):157. doi: 10.1016/j.pop.2018.10.013. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  23. Mallik A, Das N, Mukherjee S, Datta S. A systematic review and meta-analysis of different diagnostic procedures to detect gonococcus infection in resource-limited scenario Indian J Med Microbiol 2020 NaN38(3–4):299. doi: 10.4103/ijmm.ijmm_20_312. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  24. Medhi D, Dutta R, Sarma A, Sarma V, Islam B, Islam R, Saikia L. Low-cost conventional PCR techniques enable simultaneous detection of bacterial sexually transmitted infections with enhanced sensitivity and specificity Indian J Med Microbiol 2024 NaN49:100592. doi: 10.1016/j.ijmmb.2024.100592. . . ; : . [DOI] [PubMed] [Google Scholar]
  25. Naeem F, Karellis A, Nair S, Routy JP, Yansouni CP, Kim J, Pai N. Multiplexed technologies for sexually transmitted infections: global evidence on patient-centered and clinical health outcomes BMJ Glob Health 2021 NaN6(7):e005670. doi: 10.1136/bmjgh-2021-005670. . . ; ( ): . [DOI] [PMC free article] [PubMed] [Google Scholar]
  26. Papp JR, Schachter J, Gaydos CA, Van Der Pol B. Recommendations for the laboratory-based detection of Chlamydia trachomatis and Neisseria gonorrhoeae – 2014 MMWR Recomm Rep 2014 NaN 14;63(RR-02):1. . . ; ( ): –. . [PMC free article] [PubMed] [Google Scholar]
  27. Ramanan P, Bryson AL, Binnicker MJ, Pritt BS, Patel R. Syndromic Panel-Based Testing in Clinical Microbiology Clin Microbiol Rev 2017 NaN31(1):e00024. doi: 10.1128/cmr.00024-17. . . ; ( ): –. . [DOI] [PMC free article] [PubMed] [Google Scholar]
  28. Saweri OP, Batura N, Adawiyah RA, Causer L, Pomat W, Vallely A, Wiseman V. Cost and cost-effectiveness of point-of-care testing and treatment for sexually transmitted and genital infections in pregnancy in low-income and middle-income countries: A systematic review protocol BMJ Open 2019 NaN9(11):e029945. doi: 10.1136/bmjopen-2019-029945. . . ; ( ): . [DOI] [PMC free article] [PubMed] [Google Scholar]
  29. Shipitsyna E, Unemo M. A profile of the FDA-approved and CE/IVD-marked Aptima Mycoplasma genitalium assay (Hologic) and key priorities in the management of M. genitalium infections Expert Rev Mol Diagn 2020 NaN20(11):1063. doi: 10.1080/14737159.2020.1842198. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  30. Sinka K. The global burden of sexually transmitted infections Clin Dermatol 2024 NaN42(2):110. doi: 10.1016/j.clindermatol.2023.12.002. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  31. Tuddenham S, Hamill MM, Ghanem KG. Diagnosis and treatment of sexually transmitted infections: A review JAMA 2022 NaN327(2):161. doi: 10.1001/jama.2021.23487. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  32. Unemo M, Bradshaw CS, Hocking JS, de Vries HJC, Francis SC, Mabey D, Marrazzo JM, Sonder GJB, Schwebke JR, Hoornenborg E, et al. Sexually transmitted infections: Challenges ahead Lancet Infect Dis 2017 NaN17(8):e235. doi: 10.1016/s1473-3099(17)30310-9. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]
  33. Unemo M, Ross J, Serwin AB, Gomberg M, Cusini M, Jensen JS. 2020 European guideline for the diagnosis and treatment of gonorrhoea in adults Int J STD AIDS 2020 NaN:956462420949126. doi: 10.1177/0956462420949126. . . : . [DOI] [PubMed] [Google Scholar]
  34. Unemo M, Seifert HS, Hook EW, 3rd, Hawkes S, Ndowa F, Dillon JR. Gonorrhoea Nat Rev Dis Primers 2019 NaN5(1):79. doi: 10.1038/s41572-019-0128-6. . . ; ( ): . [DOI] [PubMed] [Google Scholar]
  35. Vandepitte J, Weiss HA, Bukenya J, Kyakuwa N, Muller E, Buvé A, Van der Stuyft P, Hayes RJ, Grosskurth H. Association between Mycoplasma genitalium infection and HIV acquisition among female sex workers in Uganda: Evidence from a nested case-control study Sex Transm Infect 2014 NaN90(7):545549. doi: 10.1136/sextrans-2013-051467. . . ; ( ): . [DOI] [PMC free article] [PubMed] [Google Scholar]
  36. WHO Global health sector strategies on, respectively, HIV, viral hepatitis and sexually transmitted infections for the period 2022– 2030. Geneva (Switzerland): World Health Organization; 2022. https://www.who.int/publications/i/item/9789240053779 . . : ; [2023 Dec 15]. Available from . [Google Scholar]
  37. WHO Guidelines for the management of symptomatic sexually transmitted infections. Geneva (Switzerland): World Health Organization; 2003. [2023 Dec 15]. https://www.who.int/publications/i/item/9789240024168 . . : ; [cited . ]. Available from . [PubMed] [Google Scholar]
  38. Xie TA, Liu YL, Meng RC, Liu XS, Fang KY, Deng ST, Fan SJ, Chen CM, Lin QR, He ZJ, et al. Evaluation of the Diagnostic Efficacy of Xpert CT/NG for Chlamydia trachomatis and Neisseria gon-orrhoeae Biomed Res Int 2020 NaN 8;2020:2892734. doi: 10.1155/2020/2892734. . . ; : . [DOI] [PMC free article] [PubMed] [Google Scholar]
  39. Yerushalmy J. Statistical problems in assessing methods of medical diagnosis, with special reference to X-ray techniques Public Health Rep (1896–1970) 1947 NaN62(40):1432. doi: 10.2307/4586294. . . ; ( ): –. . [DOI] [PubMed] [Google Scholar]

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