Seegene AnyPlexTM II STI-7e 与标准诊断方法检测解脲支原体、沙眼衣原体、淋病奈瑟菌和阴道毛滴虫的比较。

Comparison of Seegene AnyPlexTM II STI-7e with standard-of-care diagnostic methods for the detection of Mycoplasma genitalium, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis.

机构信息

Centre for Women's Infectious Diseases, The Royal Women's Hospital, Parkville, VIC 3052, Australia.

Murdoch Children's Research Institute, Parkville, VIC 3052, Australia.

出版信息

Lett Appl Microbiol. 2023 Jan 23;76(1). doi: 10.1093/lambio/ovac002.

DOI:10.1093/lambio/ovac002

PMID:36688743

Abstract

The AnyPlexTM II STI-7e panel assay (Seegene) detects seven sexually transmitted organisms (Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma genitalium, M. hominis, Ureaplasma urealyticum, U. parvum, and Trichomonas vaginalis). This study compared the performance of AnyPlexTM II STI-7e with standard-of-care diagnostic methods. Samples (cervical or vaginal swabs, or urine) from 1330 women were tested on standard-of-care assays; 83/1318 (6.3%) tested positive for M. genitalium (ResistancePlus® MG), 99/1317 (7.5%) positive for C. trachomatis and 11/1316 (0.8%) positive for N. gonorrhoeae (Hologic® Aptima Combo 2®), and 6/689 (0.9%) positive for T. vaginalis (wet mount microscopy). AnyPlexTM II STI-7e had good agreement for the detection of M. genitalium [Cohen's kappa of 0.80, 95% confidence intervals (CI) 0.74-0.87] and C. trachomatis (kappa of 0.87, 95% CI 0.82-0.92), with positive and negative % agreement >96% for both infections. There was lower agreement for the detection of N. gonorrhoeae (kappa of 0.37, 95%CI 0.19-0.55) and T. vaginalis (kappa of 0.521, 95%CI 0.25-0.80). In summary, the test performed well in this comparison for M. genitalium and C. trachomatis detection, but results were less conclusive for N. gonorrhoeae and T. vaginalis due to low prevalence in the population.

摘要

AnyPlexTM II STI-7e 面板检测试剂盒（Seegene）可检测七种性传播感染病原体（沙眼衣原体、淋病奈瑟菌、生殖支原体、人型支原体、解脲脲原体、微小脲原体和阴道毛滴虫）。本研究比较了 AnyPlexTM II STI-7e 与标准诊断方法的性能。对 1330 名女性的宫颈或阴道拭子或尿液样本进行了标准检测；83/1318（6.3%）的生殖支原体（ResistancePlus® MG）检测阳性，99/1317（7.5%）的沙眼衣原体和 11/1316（0.8%）的淋病奈瑟菌（Hologic® Aptima Combo 2®）检测阳性，6/689（0.9%）的阴道毛滴虫（湿片镜检）检测阳性。AnyPlexTM II STI-7e 对生殖支原体[Cohen 的 κ 值为 0.80，95%置信区间（CI）0.74-0.87]和沙眼衣原体的检测具有良好的一致性，两种感染的阳性和阴性 %一致性均>96%。淋病奈瑟菌（κ 值为 0.37，95%CI 0.19-0.55）和阴道毛滴虫（κ 值为 0.521，95%CI 0.25-0.80）的检测一致性较低。总之，该检测在本次比较中对生殖支原体和沙眼衣原体的检测表现良好，但由于人群中感染率较低，对淋病奈瑟菌和阴道毛滴虫的检测结果不具有结论性。