Performance of Anyplex™ II multiplex real-time PCR for the diagnosis of seven sexually transmitted infections: comparison with currently available methods

• Published in: International journal of infectious diseases Vol. 17; no. 12; pp. e1134 - e1140
• Main Authors: Choe, Hyun-Sop, Lee, Dong Sup, Lee, Seung-Ju, Hong, Sung-Hoo, Park, Dong Choon, Lee, Mi-Kyung, Kim, Tae-Hyoung, Cho, Yong-Hyun
• Format: Journal Article
• Language: English
• Published: Canada Elsevier Ltd 01.12.2013
• Subjects: Bacterial and parasite infection; Chlamydia trachomatis; cost effectiveness; Diagnosis; diagnostic techniques; Female; females; Humans; Incidence; Infectious Disease; Male; microorganisms; Multiplex Polymerase Chain Reaction - methods; Multiplex real-time PCR; Mycoplasma genitalium; Mycoplasma hominis; Neisseria gonorrhoeae; patients; Pulmonary/Respiratory; Quality Control; quantitative polymerase chain reaction; Reagent Kits, Diagnostic; Real-Time Polymerase Chain Reaction - methods; Reproducibility of Results; screening; Sensitivity and Specificity; sexually transmitted diseases; Sexually Transmitted Diseases - diagnosis; Sexually Transmitted Diseases - epidemiology; Sexually Transmitted Diseases - etiology; Sexually transmitted infection; Trichomonas vaginalis; Ureaplasma parvum; Ureaplasma urealyticum; urine; volunteers; Bacterial and parasite infection; Sexually transmitted infection; Diagnosis; Multiplex real-time PCR
• ISSN: 1201-9712; 1878-3511; 1878-3511
• DOI: 10.1016/j.ijid.2013.07.011

The real-time PCR assay is the most sensitive test for screening and diagnosing sexually transmitted infections (STIs) and has made diagnosing these infections easier for clinicians. The aim of this study was to investigate the reliability, accuracy, and usefulness of the real-time multiplex PCR assay for the detection of seven sexually transmitted microorganisms in clinical samples. A total of 897 specimens from 365 symptomatic patients and 532 asymptomatic volunteers were collected over a 10-month period. A total of 696 subjects provided 50ml of first-voided urine as samples, and 201 female patients provided endocervical swab specimens. Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma urealyticum, and Ureaplasma parvum were tested for using five diagnostic methods: multiplex real-time PCR (Anyplex™ II), multiplex PCR (Seeplex®), strand displacement amplification (SDA, BD ProbeTec™ ET), PCR (AmpliSens®), and a commercially available Mycoplasma IST 2 Kit. Multiplex real-time PCR (Anyplex™ II) showed outstanding results in all fields, particularly sensitivity and specificity, compared with other diagnostic tools. This method yielded 100% sensitivity and high specificity for the detection of C. trachomatis, N. gonorrhoeae, T. vaginalis, M. genitalium, and M. hominis. It was also useful for discriminating between U. urealyticum and U. parvum. Multiplex real-time PCR was found to be an equivalent or superior modality for the diagnosis of STIs. It could be a cost-effective and rapid diagnostic tool for the simultaneous detection of multiple STI microorganisms.