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Abstract

Sexually transmitted infections (STI) are a public health problem. Real-time PCR assays are the most sensitive test for screening and diagnosis of these infections. The aim of this study was to evaluate a new CT/NG/TV/MG Real-Time PCR (RT-PCR) kit (Vircell) for the detection of , , and for the diagnosis of sexual transmitted infections using the Allplex STI Essential Assay (Seegene) as the reference’s method. A total of 497 samples from different anatomical sites (endocervical, urethral, rectal, pharyngeal and urine) were analysed from October 2022 to February 2023. A total of 108 (21.73 %) and 106 (21.33 %) positive samples were found for any of the assays used. The most commonly detected pathogen was (52 samples; 10.46 %), and the least commonly detected was (three samples; 0.60 %). The anatomical site with the highest prevalence of micro-organisms was a non-urogenital site, the pharynx (26 positive samples; 5.23 %). Using the Allplex STI Essential Assay (Seegene) as the reference method, the diagnosis performance showed that the average specificity of CT/NG/TV/MG RT-PCR Kit (Vircell) was 99.84 % and the sensitivity was 99.53 %. The overall concordance was k=0.98 (CI95 %; 0.96–1). In conclusion, the CT/NG/TV/MG RT-PCR Kit (Vircell) assay shows a good sensitivity and specificity and constitutes a promising and additional alternative to routine procedures for distinct types of clinical specimen in diagnosis STI.

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2024-04-09
2024-05-18
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References

  1. World Health Organization Sexually Transmitted Infections (STIs); 2022 https://www.who.int/news-room/fact-sheets/detail/sexually-transmitted-infections-(stis)
  2. Naidu P, Shokoples S, Martin I, Zelyas N, Singh A. Evaluation of 5 commercial assays for the detection of Mycoplasma genitalium and other Urogenital Mycoplasmas. Med Microbiol Immunol 2021; 210:73–80 [View Article] [PubMed]
    [Google Scholar]
  3. Guidelines review Committee, global HIV H and STIP Guidelines for the Management of Symptomatic Sexually Transmitted Infections; 2021 https://www.who.int/publications/i/item/9789240024168%0Ahttp://www.who.int/Reproductive_health http://www.who.int/HIV_AIDS/
  4. López de Munain J. Epidemiology and current control of sexually transmitted infections. The role of STI clinics. Enferm Infecc Microbiol Clin 201945–49 [View Article] [PubMed]
    [Google Scholar]
  5. Barrientos-Durán A, de Salazar A, Fuentes-López A, Serrano-Conde E, Espadafor B et al. Comparison between Aptima® assays (Hologic) and the CoBAS® 6800 system (Roche) for the diagnosis of sexually transmitted infections caused by Chlamydia trachomatis, Neisseria gonorrhoeae, and Mycoplasma genitalium. Eur J Clin Microbiol Infect Dis 2021; 40:1337–1342 [View Article] [PubMed]
    [Google Scholar]
  6. Choe HS, Lee DS, Lee SJ, Hong SH, Park DC et al. Performance of Anyplex™ II multiplex real-time PCR for the diagnosis of seven sexually transmitted infections: comparison with currently available methods. Int J Infect Dis 2013; 17:e1134-40 [View Article] [PubMed]
    [Google Scholar]
  7. Tuddenham S, Hamill MM, Ghanem KG. Diagnosis and treatment of sexually transmitted infections: a review. JAMA 2022; 327:161–172 [View Article] [PubMed]
    [Google Scholar]
  8. Barrientos-Durán A, de Salazar A, Alvarez-Estévez M, Fuentes-López A, Espadafor B et al. Detection of sexually transmitted disease-causing pathogens from direct clinical specimens with the multiplex PCR-based STD direct flow chip kit. Eur J Clin Microbiol Infect Dis 2020; 39:235–241 [View Article] [PubMed]
    [Google Scholar]
  9. Le Roy C, Bébéar C, Pereyre S. Performance of three commercial molecular diagnostic assays for the simultaneous detection of Mycoplasma genitalium and macrolide resistance. J Clin Microbiol 2021; 59:e00020-21 [View Article] [PubMed]
    [Google Scholar]
  10. World Health Organization Laboratory diagnosis of sexually transmitted infections, including human immunodefiency virus; 2013 https://iris.who.int/bitstream/handle/10665/85343/9789241505840_eng.pdf?sequence=1)
  11. Khosropour CM, Soge OO, Golden MR, Hughes JP, Barbee LA. Incidence and duration of pharyngeal chlamydia among a cohort of men who have sex with men. Clin Infect Dis 2022; 75:875–881 [View Article] [PubMed]
    [Google Scholar]
  12. Barbee LA, Soge OO, Khosropour CM, LeClair A, Golden MR. Time to clearance of Neisseria gonorrhoeae RNA at the pharynx following treatment. J Clin Microbiol 2022; 60:e0039922 [View Article] [PubMed]
    [Google Scholar]
  13. Rumyantseva T, Golparian D, Nilsson CS, Johansson E, Falk M et al. Evaluation of the new AmpliSens multiplex real-time PCR assay for simultaneous detection of Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis. APMIS 2015; 123:879–886 [View Article] [PubMed]
    [Google Scholar]
  14. Robinet S, Parisot F. Accreditation of a multiplex real time PCR assay for detection and semi-quantitative determination of pathogens responsible of sexually-transmitted infections. Ann Biol Clin 2018; 76:459–476 [View Article] [PubMed]
    [Google Scholar]
  15. Yassin R, Hanna J, El Bikai R, Mohtar J, El Chaar M. Comparison of two commercial multiplex PCR assays for the detection of sexually transmitted infections. J Infect Dev Ctries 2022; 16:333–338 [View Article] [PubMed]
    [Google Scholar]
  16. Horner P, Donders G, Cusini M, Gomberg M, Jensen JS et al. Should we be testing for urogenital Mycoplasma hominis, Ureaplasma parvum and Ureaplasma urealyticum in men and women? - a position statement from the European STI Guidelines Editorial Board. J Eur Acad Dermatol Venereol 2018; 32:1845–1851 [View Article] [PubMed]
    [Google Scholar]
  17. Plummer EL, Vodstrcil LA, Bodiyabadu K, Murray GL, Doyle M et al. Are Mycoplasma hominis, Ureaplasma urealyticum and Ureaplasma parvum associated with specific genital symptoms and clinical signs in nonpregnant women?. Clin Infect Dis 2021; 73:659–668 [View Article] [PubMed]
    [Google Scholar]
  18. Huh HJ, Ki CS, Yun SA, Lee J, Oh GY et al. Comparison between DiaPlexQ™ STI6 and GeneFinder™ STD I/STD II multiplex Real-time PCR kits in the detection of six sexually transmitted disease pathogens. J Clin Lab Anal 2019; 33:e22703 [View Article] [PubMed]
    [Google Scholar]
  19. Jensen JS, Björnelius E, Dohn B, Lidbrink P. Use of TaqMan 5’ nuclease real-time PCR for quantitative detection of Mycoplasma genitalium DNA in males with and without urethritis who were attendees at a sexually transmitted disease clinic. J Clin Microbiol 2004; 42:683–692 [View Article] [PubMed]
    [Google Scholar]
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