Jacobsson Susanne, Boiko Iryna, Golparian Daniel, Blondeel Karel, Kiarie James, Toskin Igor, Peeling Rosanna W, Unemo Magnus
WHO Collaborating Centre for Gonorrhoea and Other Sexually Transmitted Infections, National Reference Laboratory for Sexually Transmitted Infections, Department of Laboratory Medicine, Faculty of Medicine and Health, Örebro University, Örebro, Sweden.
Clinical Laboratory Department, Ternopil Regional Clinical Dermatovenerologic Dispensary, Ternopil, Ukraine.
APMIS. 2018 Dec;126(12):907-912. doi: 10.1111/apm.12902.
Effective tests for diagnosis of sexually transmitted infections (STIs), used point of care to inform treatment and management decisions, are urgently needed. We evaluated the analytical sensitivity and specificity of the Xpert CT/NG and Xpert TV tests, examining 339 samples spiked with phenotypically and/or genetically diverse strains of Neisseria gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis, and other related species that may cross-react. The APTIMA Combo 2 test and APTIMA TV test were used as reference tests. The analytical sensitivity for all three agents in the Xpert CT/NG and Xpert TV tests was ≤10 genome equivalents/reaction. The analytical specificity of both tests was high. False-positive results were identified in the Xpert TV test when challenging with high concentrations of Trichomonas tenax, Trichomonas gallinae, Trichomonas stableri, and Trichomonas aotus. However, the clinical relevance of these cross-reactions can likely be neglected, because these species have not been identified in urogenital samples from humans. In conclusion, the analytical sensitivity and specificity of the user-friendly Xpert CT/NG and Xpert TV tests on the GeneXpert system were high. The results support the use of specimens from also extra-genital sites, for example, pharynx and rectum. However, appropriate clinical validations are additionally required.
迫切需要有效的性传播感染（STIs）诊断检测方法，以便在护理点为治疗和管理决策提供依据。我们评估了Xpert CT/NG和Xpert TV检测的分析灵敏度和特异性，检测了339份添加了淋病奈瑟菌、沙眼衣原体、阴道毛滴虫以及其他可能发生交叉反应的相关物种的表型和/或基因多样菌株的样本。采用APTIMA Combo 2检测和APTIMA TV检测作为参考检测方法。Xpert CT/NG和Xpert TV检测对所有三种病原体的分析灵敏度均≤10个基因组当量/反应。两种检测的分析特异性都很高。在用高浓度的口腔毛滴虫、鸽毛滴虫、斯氏毛滴虫和奥氏毛滴虫进行挑战时，Xpert TV检测中出现了假阳性结果。然而，这些交叉反应的临床相关性可能可以忽略不计，因为在人类泌尿生殖系统样本中尚未发现这些物种。总之，GeneXpert系统上用户友好的Xpert CT/NG和Xpert TV检测的分析灵敏度和特异性都很高。结果支持使用来自生殖器外部位（如咽部和直肠）的样本。然而，还需要进行适当的临床验证。
