Background Sexually transmitted infections (STIs) have serious negative consequences for reproductive health worldwide. They are associated with infertility, premature birth and neonatal infections. Five STI pathogens, namely Trichomonas vaginalis, Mycoplasma genitalium, Mycoplasma hominis, Ureaplasma parvum, and Ureaplasma urealyticum were selected for the evaluation of three potential real-time PCR assays that can be adopted for diagnostic testing. Methods A total of 36 samples were included, consisting of genital swabs, urine, abscesses and samples provided by quality assurance programmes. DNA extraction was performed using an automated nucleic acid extraction system, abGenixTM. Commercial genomic controls and DNA extracts donated by external laboratories were used as well. The extracted nucleic acids were tested using three different assays, namely Seegene Anyplex II STI-5 Detection, Thermo Fisher Scientific customized STI Panel assay, and TIB MOLBIOL STI LightMix Modular kits, according to the manufacturers’ instructions. Results A total of 67% and 11% of the samples showed equivalent positive and negative results, respectively. However, 22% of the samples had non-concordant results. TIB MOLBIOL STI LightMix Modular kit was unable to differentiate between Ureaplasma parvum and Ureaplasma urealyticum in 9 samples. Genomic controls were tested, and Seegene Anyplex II STI-5 Detection was unable to detect lower concentrations of DNA for Trichomonas vaginalis, Mycoplasma genitalium and Mycoplasma hominis. All assays were able to detect lower concentrations of Ureaplasma parvum DNA, but detectable concentrations were higher for Ureaplasma urealyticum. Conclusions In conclusion, the performance of each assay differed according to pathogen. None of the assays offered equal performance for all pathogens. We have adopted Thermo Fisher Scientific customized STI Panel assay in our diagnostic testing due to its advantage of being user friendly and cost effective.

中文翻译：

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A-302 实时 PCR 检测性传播感染检测的评估


背景 性传播感染（STI）对全世界的生殖健康产生严重的负面影响。它们与不孕、早产和新生儿感染有关。选择五种 STI 病原体，即阴道毛滴虫、生殖支原体、人型支原体、微小解脲支原体和解脲脲原体，对三种可用于诊断检测的潜在实时 PCR 检测进行评估。方法 总共纳入 36 个样本，包括生殖器拭子、尿液、脓肿和质量保证项目提供的样本。使用自动化核酸提取系统 abGenixTM 进行 DNA 提取。还使用了商业基因组对照和外部实验室捐赠的 DNA 提取物。根据制造商的说明，使用三种不同的测定法对提取的核酸进行测试，即 Seegene Anyplex II STI-5 检测、Thermo Fisher Scientific 定制 STI Panel 测定法和 TIB MOLBIOL STI LightMix 模块化试剂盒。结果 总共 67% 和 11% 的样本分别显示出相同的阳性和阴性结果。然而，22% 的样本结果不一致。 TIB MOLBIOL STI LightMix 模块化试剂盒无法区分 9 个样品中的微小解脲支原体和解脲脲原体。经过基因组对照测试，Seegene Anyplex II STI-5 检测无法检测到较低浓度的阴道毛滴虫、生殖支原体和人型支原体 DNA。所有检测均能够检测到较低浓度的微小解脲支原体 DNA，但解脲脲原体的可检测浓度较高。结论 总之，每种检测的性能因病原体而异。 没有一种检测方法能够对所有病原体提供相同的性能。我们在诊断测试中采用了 Thermo Fisher Scientific 定制的 STI Panel 检测，因为它具有用户友好且具有成本效益的优势。