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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

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Abstract

Nowadays, it is of utmost importance to use fully validated assays for molecular-based diagnosis. In the field of sexually transmitted disease (STD), Roche and Hologic provide assays for diagnosing Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Mycoplasma genitalium (MG), and Trichomonas vaginalis (TV). A total of 212 clinical samples were tested. Aptima® Combo 2 (detecting CT and NG), Aptima® M. genitalium and the Aptima® T. vaginalis on the Panther® system were compared to CoBAS® CT/NG and CoBAS® TV/MG running on the CoBAS® 6800 system. To solve the discrepancies, Allplex™ STI Essential assay (Seegene®) and/or Sanger DNA sequencing were used. The diagnostic performance was calculated by mean of the sensitivity and specificity parameters. Aptima® (sensitivity: 98.90%, specificity: 100%), CoBAS® (sensitivity 100%, specificity: 96.67%). The CoBAS® combo (CT/NG) failed detecting NG from an anal/rectum specimen, which is not included into the validated specimens of the assay. Aptima® combo 2 produced two false positives (CT and NG), not detected by the third tests. All the assays showed an optimal diagnostic capacity, meeting the requirements for IVD DNA–based assays. All products work optimally on automatic platforms, minimizing time and risk of contamination during handling.

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All data are included within the manuscript. No supplementary data is provided.

References

  1. Report on global sexually transmitted infection surveillance, 2018. Geneva: World Health Organization; 2018. Available in: https://apps.who.int/iris/bitstream/handle/10665/277258/9789241565691-eng.pdf?ua=1

  2. Gaydos CA, Quinn TC, Willis D, Weissfeld A, Hook EW, Martin DH, Ferraro DV, Schachter J (2003) Performance of the Aptima combo 2 assay for detection of chlamydia trachomatis and Neisseria gonorrhoeae in female urine and endocervical swab specimens. J Clin Microbiol 41:304–309

    Article  CAS  Google Scholar 

  3. Levett PN, Brandt K, Olenius K, Brown C, Montgomery K, Horsman GB (2008) Evaluation of three automated nucleic acid amplification systems for the detection of chlamydia trachomatis and Neisseria gonorrhoeae in first-void urine specimens. J Clin Microbiol 46:2109–2111

    Article  CAS  Google Scholar 

  4. Cheng A, Qian Q, Kirby JE (2011) Evaluation of the Abbott RealTime CT/NG assay in comparison to the Roche Cobas Amplicor CT/NG assay. J Clin Microbiol 49:1294–1300

    Article  CAS  Google Scholar 

  5. Footman A, Dionne-Odom J, Aaron KJ, Raper JL, Van Der Pol B (2020) Performance of 4 molecular assays for detection of chlamydia and gonorrhea in a sample of human immunodeficiency virus-positive men who have sex with men. Sex Transm Dis 47(3):158–161. https://doi.org/10.1097/OLQ.0000000000001115

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  6. Frontzek A, Aretzweiler G, Winkens D, Duncan D, Marlowe EM (2019) High-volume workflow and performance comparisons for Chlamydia trachomatis and Neisseria gonorrhoeae testing using automated molecular platforms. BMC Infect Dis 19(1):797. https://doi.org/10.1186/s12879-019-4442-0

    Article  PubMed  PubMed Central  Google Scholar 

  7. Bilder CR, Tebbs JM, McMahan CS (2019) Informative group testing for multiplex assays. Biometrics. 75(1):278–288. https://doi.org/10.1111/biom.12988

    Article  PubMed  PubMed Central  Google Scholar 

  8. Shipitsyna E, Zolotoverkhaya E, Chen CY, Chi KH, Grigoryev A, Savicheva A et al (2013) Evaluation of polymerase chain reaction assays for the diagnosis of Trichomonas vaginalis infection in Russia. J Eur Acad Dermatol Venereol 27:e217–e223

    Article  CAS  Google Scholar 

  9. Choe HS, Lee DS, Lee S-J, Hong S-H, Park DC, Lee M-K et al (2013) 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 17:1134–1140

    Article  Google Scholar 

  10. Berçot B, Amarsy R, Goubard A, Aparicio C, Loeung HU, Segouin C et al (2015) Assessment of co-infection of sexually transmitted pathogen microbes by use of the Anyplex™ II STI-7 molecular kit. J Clin Microbiol 53:991–993

    Article  Google Scholar 

  11. Fernández G, Martró E, González V, Saludes V, Bascuñana E, Marcó C et al (2016) Usefulness of a novel multiplex real-time PCR assay for the diagnosis of sexually-transmitted infections. Enferm Infecc Microbiol Clin 34:471–476

    Article  Google Scholar 

  12. Barrientos-Durán A, de Salazar A, Alvarez-Estévez M, Fuentes-López A, Espadafor B, Garcia F (2020) 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 39(2):235–241. https://doi.org/10.1007/s10096-019-03686-wEpub 2020 Jan 4

    Article  CAS  PubMed  Google Scholar 

  13. Bebear C, de Barbeyrac B (2009) Genital Chlamydia trachomatis infections. Clinical Microbial Infect 15:4–10

    Article  CAS  Google Scholar 

  14. Haggerty CL, Ness RB (2006) Epidemiology, pathogenesis and treatment of pelvic inflammatory disease. Expert Rev Anti-Infect Ther 4:235–247

    Article  CAS  Google Scholar 

  15. Centers for Disease Control and Prevention. 2016. Gonorrhea-CDC Fact Sheet. https://www.cdc.gov/std/gonorrhea/stdfact-gonorrheadetailed.htm

  16. Centers for Disease Control and Prevention. 2016. STD risk and oral sex-CDC Fact Sheet. https://www.cdc.gov/std/healthcomm/stdfact-stdriskandoralsex.htm

  17. Masi AT, Eisenstein BI (1981) Disseminated gonococcal infections (DGI) and gonococcal arthritis (GCA): II clinical manifestations, diagnosis, complications, treatment and prevention. Semin Arthritis Rheum 10:173

    Article  CAS  Google Scholar 

  18. Jensen JS (2006) Mycoplasma genitalium infections. Diagnosis, clinical aspects, and pathogenesis. Dan Med Bull 53:1–27

    PubMed  Google Scholar 

  19. Sethi S, Singh G, Samanta P, Sharma M (2012) Mycoplasma genitalium: an emerging sexually transmitted pathogen. Indian J Med Res 136:942–955

    CAS  PubMed  PubMed Central  Google Scholar 

  20. Daley GM, Russell DB, Tabrizi SN, McBride J (2014) Mycoplasma genitalium: a review. Int J STD AIDS 25:475–487

    Article  CAS  Google Scholar 

  21. Getman D, Jiang A, O’Donnell M, Cohen S (2016) Mycoplasma genitalium prevalence, coinfection, and macrolide antibiotic resistance frequency in a multicenter clinical study cohort in the United States. J Clin Microbiol 54(9):2278–2283. https://doi.org/10.1128/JCM.01053-16

    Article  PubMed  PubMed Central  Google Scholar 

  22. Kissinger P (2015) Trichomonas vaginalis: a review of epidemiologic, clinical and treatment issues. BMC Infect Dis 15:307

    Article  Google Scholar 

  23. Herring A, Ballard R, Mabey D, Peeling RW (2006) Evaluation of rapid diagnostic tests: chlamydia and gonorrhoea. Nat Rev Microbiol 4:S41–S48

    Article  Google Scholar 

  24. Banoo S, Bell D, Bossuyt P, Herring A, Mabey D, Poole F et al (2010) Evaluation of diagnostic tests for infectious diseases: general principles. Nat Rev Microbiol. 8:S17–S12

    Article  Google Scholar 

  25. Doernberg, S.B.; Komarow, L.; Tran, T.T.T.; Sund, Z.; Pandori, M.W.; Jensen, D.; Tsalik, E.L.; Deal, C.D.; Chambers, H.F.; Fowler, V.G.; et al. Simultaneous evaluation of diagnostic assays for pharyngeal and rectal Neisseria gonorrhoeae and Chlamydia trachomatis using a master protocol. Clin. Infect. Dis. 2019, ciz1105, doi:https://doi.org/10.1093/cid/ciz110

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Acknowledgments

The results published here are part of the thesis’s work of the PhD candidate Adolfo de Salazar, in the Biomedicine Doctoral Program of the University of Granada.

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Authors

Contributions

Collection and storage of clinical specimens: A.F-L, E. S-C, B.E., A.dS.; validation: A.dS., A.B-D, A.F-L, N.C.; writing—original draft preparation: A.B-D., A.dS.; writing—review and editing: A.B-D, F.G.; project administration: M.A-E.; F.G.; funding acquisition: F.G.

Corresponding author

Correspondence to Federico Garcia.

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Ethical approval

The study was designed and conducted according to the principles expressed in the Declaration of Helsinki and, was approved by the local Ethics Committee of Hospital Universitario Clínico San Cecilio (Granada).

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Verbal informed consent was obtained from all participants.

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All authors have read and agreed to the published version of the manuscript.

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The authors declare that they have no conflict of interest.

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Barrientos-Durán, A., de Salazar, A., Fuentes-López, A. 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 40, 1337–1342 (2021). https://doi.org/10.1007/s10096-020-04143-9

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  • DOI: https://doi.org/10.1007/s10096-020-04143-9

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