Pereyre Sabine, Caméléna François, Hénin Nadège, Berçot Béatrice, Bébéar Cécile
University of Bordeaux, USC EA 3671 Mycoplasmal and Chlamydial Infections in Humans, Bordeaux, France; Bordeaux University Hospital, Bacteriology Department, National Reference Centre for Bacterial Sexually Transmitted Infections, Bordeaux, France.
Saint-Louis Hospital, APHP, Bacteriology Unit, National Reference Centre for Bacterial Sexually Transmitted Infections, Paris, France; University of Paris, INSERM, IAME, UMR1137, Paris, France.
Clin Microbiol Infect. 2022 May;28(5):733.e7-733.e13. doi: 10.1016/j.cmi.2021.09.028. Epub 2021 Oct 2.
We evaluated the clinical performances of four multiplex real-time PCR commercial kits for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium and Trichomonas vaginalis: the STI PLUS ELITe MGB kit (ELITechGroup), N. gonorrhoeae/C. trachomatis/M. genitalium/T.vaginalis Real-TM kit (Sacace Biotechnologies), Allplex STI Essential kit (Seegene), and FTD Urethritis Plus kit (Fast-Track Diagnostics).
The kit performance for C. trachomatis, N. gonorrhoeae, M. genitalium and T. vaginalis detection was compared to that of the cobas CT/NG and TV/MG kits (Roche Diagnostics) using 425 samples, mainly urine and cervicovaginal, throat and rectal swabs. Detection of Ureaplasma parvum, U. urealyticum and Mycoplasma hominis were compared to that of in-house TaqMan PCRs.
The four kits showed good performances for the detection of C. trachomatis. They all presented a low positive agreement for the detection of M. genitalium and T. vaginalis (ranges 63.3-74.1% and 51.2-68.4%, respectively) compared to the cobas MG/TV kit. The Seegene and Sacace kits showed additional low positive agreement for the detection of N. gonorrhoeae (71.2%, 95%CI 61.8-79.0 and 63.1%, 95%CI 53.5-71.8, respectively). We observed a slight but significant lower negative agreement for N. gonorrhoeae detection using the ELITechGroup kit (92.5%, 89.1-94.9) and for M. genitalium detection using the Fast-Track kit (93.2%, 89.6-95.7) compared to other kits.
Multiplex real-time PCR kits are convenient methods for the detection of several pathogens associated with sexually transmitted infections (STIs) in a single step, but colonizing Ureaplasma spp. and M. hominis species should not be included in these kits. Users should be aware of the weak performance of some kits for the detection of M. genitalium and T. vaginalis.
我们评估了四种用于检测沙眼衣原体、淋病奈瑟菌、生殖支原体和阴道毛滴虫的多重实时聚合酶链反应（PCR）商业试剂盒的临床性能：性传播感染（STI）PLUS ELITe MGB试剂盒（ELITechGroup公司）、淋病奈瑟菌/沙眼衣原体/生殖支原体/阴道毛滴虫Real-TM试剂盒（Sacace生物技术公司）、Allplex STI Essential试剂盒（Seegene公司）和FTD尿道炎加强版试剂盒（快速诊断公司）。
使用425份样本（主要是尿液、宫颈阴道、咽喉和直肠拭子），将检测沙眼衣原体、淋病奈瑟菌、生殖支原体和阴道毛滴虫的试剂盒性能与cobas CT/NG和TV/MG试剂盒（罗氏诊断公司）进行比较。将微小脲原体、解脲脲原体和人型支原体的检测结果与内部TaqMan PCR检测结果进行比较。
这四种试剂盒在检测沙眼衣原体方面表现良好。与cobas MG/TV试剂盒相比，它们在检测生殖支原体和阴道毛滴虫方面的阳性一致性均较低（分别为63.3%-74.1%和51.2%-68.4%）。Seegene和Sacace试剂盒在检测淋病奈瑟菌方面的阳性一致性也较低（分别为71.2%，95%CI 61.8-79.0和63.1%，95%CI 53.5-71.8）。与其他试剂盒相比，我们观察到使用ELITechGroup试剂盒检测淋病奈瑟菌时阴性一致性略低但有显著差异（92.5%，89.1-94.9），使用快速诊断试剂盒检测生殖支原体时阴性一致性略低但有显著差异（93.2%，89.6-95.7）。
多重实时PCR试剂盒是一步检测多种性传播感染（STI）相关病原体的便捷方法，但不应将定植的脲原体属和人型支原体纳入这些试剂盒。使用者应注意某些试剂盒在检测生殖支原体和阴道毛滴虫方面性能较弱。
