Comparison between Aptima Assays (Hologic) and the Allplex STI Essential Assay (Seegene) for the diagnosis of Sexually transmitted infections

Autoři: Adolfo de Salazar aff001;  Beatriz Espadafor aff002;  Ana Fuentes-López aff001;  Antonio Barrientos-Durán aff001;  Luis Salvador aff002;  Marta Álvarez aff001;  Federico García aff001
Působiště autorů: Hospital Universitario San Cecilio, Servicio de Microbiología, Instituto de Investigación Ibs, Granada, Spain aff001;  Hospital Universitario Virgen de las Nieves, Servicio de Dermatología, Centro de ETS, Granada, Spain aff002
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: 10.1371/journal.pone.0222439


Sexually transmitted infections (STIs) remain a worldwide problem and a severe threat to public health. The purpose of this study was to compare Aptima® Assays (Hologic®) and the Allplex STI Essential Assay (Seegene®) for the simultaneous detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and Mycoplasma genitalium in clinical practice. The Aptima® assays (Hologic®) are based on a transcription-mediated amplification (TMA) method. The Allplex STI Essential assay (Seegene®) is based on a multiplex Real-Time PCR (RT-PCR) method. A total of 622 clinical samples from different anatomical sites were tested using both methods. A total of 88 (14.1%) and 66 (10.6%) positive samples were found for any of the TMA assays used and for the RT-PCR assay, respectively. Aptima® assays showed a slightly higher rate of positive results for all pathogens except for T. vaginalis, the results of which were similar to those obtained with Allplex. The most commonly detected pathogen was C. trachomatis (37 samples; 5.9% using TMA assays) and the anatomical site with the highest prevalence of microorganisms was a non-urogenital site, the pharynx (27 positive samples; 4.3%). Using the Aptima® assays as reference method, the comparison showed that the average specificity of multiplex RT-PCR was 100.0% for the four pathogens. However an average sensitivity of 74.5% was observed, showing 95.2% (CI95%; 93.6–96.9) of overall concordance (κ = 0.80). In conclusion, the Aptima® assays show a higher sensitivity on a wide range of sample types compared to the Allplex assay.

Klíčová slova:

Biology and life sciences – Microbiology – Medical microbiology – Microbial pathogens – Bacterial pathogens – Organisms – Bacteria – Chlamydia – Neisseria – Eukaryota – Protists – Trichomonas – Trichomonas vaginalis – Anatomy – Body fluids – Physiology – Molecular biology – Molecular biology techniques – Artificial gene amplification and extension – Polymerase chain reaction – Reverse transcriptase-polymerase chain reaction – Biochemistry – Nucleic acids – Medicine and health sciences – Pathology and laboratory medicine – Pathogens – Chlamydia trachomatis – Neisseria gonorrhoeae – Urine – Infectious diseases – Sexually transmitted diseases – Chlamydia infection – Research and analysis methods


1. World Health Organization. Report on global sexually transmitted infection surveillance 2015. WHO; 2016.

2. Baumann L, Cina M, Egli-Gany D, Goutaki M, Halbeisen FS, Lohrer G-R, et al. Prevalence of Mycoplasma genitalium in different population groups: systematic review andmeta-analysis. Sex Transm Infect. 2018;94(4):255–62. doi: 10.1136/sextrans-2017-053384 29440466

3. Manhart LE, Broad JM, Golden MR. Mycoplasma genitalium: Should We Treat and How? Clin Infect Dis. 2011;53(suppl_3):S129–42.

4. Malhotra M, Sood S, Mukherjee A, Muralidhar S, Bala M. Genital Chlamydia trachomatis: An update. Indian J Med Res. 2013;138(3):303–16. 24135174

5. Alirol E, Wi TE, Bala M, Bazzo ML, Chen X-S, Deal C, et al. Multidrug-resistant gonorrhea: A research and development roadmap to discover new medicines. PLOS Medicine. 2017;14(7):e1002366. doi: 10.1371/journal.pmed.1002366 28746372

6. Edwards T, Burke P, Smalley H, Hobbs G. Trichomonas vaginalis: Clinical relevance, pathogenicity and diagnosis. Crit Rev Microbiol. 2014;1–12.

7. Vos T, Barber RM, Bell B, Bertozzi-Villa A, Biryukov S, Bolliger I, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. The Lancet. 2015;386(9995):743–800.

8. Sieving RE, Gewirtz O’Brien JR, Saftner MA, Argo TA. Sexually transmitted diseases among us adolescents and young adults. Nursing Clinics of North America. 2019;54(2):207–25. doi: 10.1016/j.cnur.2019.02.002 31027662

9. Nye MB, Schwebke JR, Body BA. Comparison of APTIMA Trichomonas vaginalis transcription-mediated amplification to wet mount microscopy, culture, and polymerase chain reaction for diagnosis of trichomoniasis in men and women. Am J Obstet Gynecol. 2009;200(2):188.e1–188.e7.

10. Boyadzhyan B, Yashina T, Yatabe JH, Patnaik M, Hill CS. Comparison of the APTIMA CT and GC Assays with the APTIMA Combo 2 Assay, the Abbott LCx Assay, and Direct Fluorescent-Antibody and Culture Assays for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae. J Clin Microbiol. 2004;42(7):3089–93. doi: 10.1128/JCM.42.7.3089-3093.2004 15243065

11. Golparian D, Tabrizi SN, Unemo M. Analytical Specificity and Sensitivity of the APTIMA Combo 2 and APTIMA GC Assays for Detection of Commensal Neisseria Species and Neisseria gonorrhoeae on the Gen-Probe Panther Instrument: Sex Transm Dis. 2013;40(2):175–8. doi: 10.1097/OLQ.0b013e3182787e45 23324980

12. Wroblewski JKH, Manhart LE, Dickey KA, Hudspeth MK, Totten PA. Comparison of transcription-mediated amplification and PCR assay results for various genital specimen types for detection of Mycoplasma genitalium. J Clin Microbiol. 2006;44(9):3306–12. doi: 10.1128/JCM.00553-06 16954265

13. Tabrizi SN, Unemo M, Limnios AE, Hogan TR, Hjelmevoll S-O, Garland SM, et al. Evaluation of Six Commercial Nucleic Acid Amplification Tests for Detection of Neisseria gonorrhoeae and Other Neisseria Species. J Clin Microbiol. 2011;49(10):3610–5. doi: 10.1128/JCM.01217-11 21813721

14. Chernesky M, Jang D, Luinstra K, Chong S, Smieja M, Cai W, et al. High Analytical Sensitivity and Low Rates of Inhibition May Contribute to Detection of Chlamydia trachomatis in Significantly More Women by the APTIMA Combo 2 Assay. J Clin Microbiol. 2006;44(2):400–5. doi: 10.1128/JCM.44.2.400-405.2006 16455891

15. Hokynar K, Hiltunen-Back E, Mannonen L, Puolakkainen M. Prevalence of Mycoplasma genitalium and mutations associated with macrolide and fluoroquinolone resistance in Finland. Int J STD AIDS. 2018;29(9):904–7. doi: 10.1177/0956462418764482 29631509

16. Rumyantseva T, Golparian D, Nilsson CS, Johansson E, Falk M, Fredlund H, 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(10):879–86. doi: 10.1111/apm.12430

17. Levett PN, Brandt K, Olenius K, Brown C, Mont- gomery K, Horsman GB. Evaluation of three automated nucleic acid amplification systems for detection of Chlamydia trachomatis and Neisseria gonorrhoeae in first-void urine specimens. J Clin Microbiol 2008;46:2109–11. doi: 10.1128/JCM.00043-08 18400919

18. Chun J-Y, Kim K-J, Hwang I-T, Kim Y-J, Lee D-H, Lee I-K, et al. Dual priming oligonucleotide system for the multiplex detection of respiratory viruses and SNP genotyping of CYP2C19 gene. Nucleic Acids Res. 2007;35(6):e40. doi: 10.1093/nar/gkm051 17287288

19. Gonzales F, McDonough SH. Application of transcription-mediated amplification to quantification of gene sequences. In: Ferré F. (eds). Gene Quantification. Advanced Biomedical Technologies. Birkhäuser Boston; 1998. p. 189–201.

20. Choe H-S, Lee DS, Lee S-J, Hong S-H, Park DC, Lee M-K, 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(12):e1134–40. doi: 10.1016/j.ijid.2013.07.011

21. Del Prete R, Ronga L, Lestingi M, Addati G, Angelotti UF, Di Carlo D, et al. Simultaneous detection and identification of STI pathogens by multiplex Real-Time PCR in genital tract specimens in a selected area of Apulia, a region of Southern Italy. Infection. 2017;45(4):469–77. doi: 10.1007/s15010-017-1002-7 28260146

22. 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 (Paris). 20187–8;(4):459–476.

23. European Centre for Disease Prevention and Control. Chlamydia infection. In: ECDC. Annual epidemiological report for 2017. Stockholm: ECDC; 2019.

24. Hananta IPY, de Vries HJC, van Dam AP, van Rooijen MS, Soebono H, Schim van der Loeff MF. Spontaneous clearance of pharyngeal gonococcal infections: a retrospective study in patients of the sexually transmitted infections clinic, Amsterdam, the Netherlands 2012–2015. Sexually Transmitted Diseases. 2018;1.

25. Le Roy C, Pereyre S, Hénin N, Bébéar C. French Prospective Clinical Evaluation of the Aptima Mycoplasma genitalium CE-IVD Assay and Macrolide Resistance Detection Using Three Distinct Assays. Munson E, editor. J Clin Microbiol. 2017;55(11):3194–200. doi: 10.1128/JCM.00579-17 28794183

26. Whittles LK, Didelot X, Grad YH, White PJ. Testing for gonorrhoea should routinely include the pharynx. Lancet Infect Dis. 2018;18(7):716–7.

27. Garner AL, Schembri G, Cullen T, Lee V. Should we screen heterosexuals for extra-genital chlamydial and gonococcal infections? Int J STD AIDS. 2015;26(7):462–6. doi: 10.1177/0956462414543120 25013220

28. Cheng A, Kirby JE. Evaluation of the Hologic Gen-Probe PANTHER, APTIMA Combo 2 Assay in a Tertiary Care Teaching Hospital. Am J Clin Pathol. 2014;141(3):397–403. doi: 10.1309/AJCPFQ25SQVZAWHZ 24515768

29. Rantakokko-Jalava K, Hokynar K, Hieta N, Keskitalo A, Jokela P, Muotiala A, et al. Chlamydia trachomatis samples testing falsely negative in the Aptima Combo 2 test in Finland, 2019. Eurosurveillance. 2019;24(22):1900298.

30. Unemo M, Hansen M, Hadad R, Lindroth Y, Fredlund H, Puolakkainen M, et al. Finnish new variant of Chlamydia trachomatis escaping detection in the Aptima Combo 2 assay also present in Örebro County, Sweden, May 2019. Eurosurveillance. 2019;24(26):1900370.

31. Chapin K, Andrea S. APTIMA® Trichomonas vaginalis, a transcription-mediated amplification assay for detection of Trichomonas vaginalis in urogenital specimens. Expert Review of Molecular Diagnostics. 2011;11(7):679–88. doi: 10.1586/erm.11.53

32. Kucknoor AS, Mundodi V, Alderete J. Genetic identity and differential gene expression between Trichomonas vaginalis and Trichomonas tenax. BMC Microbiol. 2009;9(1):58.

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