Objectives To evaluate the accuracy, susceptibility and specificity of MYCOPLASMA IST3, the next generation of the most popular culture-based in vitro diagnostic device designed to detect, identify and test the susceptibility of urogenital mycoplasma infections. Methods MYCOPLASMA IST3 was evaluated against culture- and molecular-based gold standard methodologies to detect, identify, enumerate and determine antimicrobial resistance for Mycoplasma hominis and Ureaplasma species in 516 clinical samples collected across France, Serbia and the UK. Sample types included vulvovaginal/endocervical or urethral swabs (dry swab or eSwab®), semen and urine samples, which included blinded analysis following addition of a panel of 80 characterized control strains. Results Overall species identification was excellent for both Ureaplasma spp. (98.4% sensitivity, 99.7% specificity) and M. hominis (95.7% sensitivity, 100% specificity) relative to combined colony morphology on agar and quantitative PCR standards. Non-dilution-based bacterial load estimation by the assay was accurate between 83.7% (M. hominis) and 86.3% (Ureaplasma spp.) of the time (increased to 94.2% and 100%, respectively, if ±10-fold variance was allowed) relative to colonies counted on agar. Resistance accuracy for Ureaplasma spp. varied from gold standards for only 11/605 of individual tests (major error rate = 1.8%) and for 14/917 individual tests for M. hominis (major error rate = 1.5%). Conclusions The redesigned MYCOPLASMA IST3 assay eliminated previous shortcomings by providing independent accurate resistance screening of M. hominis and Ureaplasma species, even in mixed infections, with CLSI-compliant thresholds. Specificity, sensitivity and enumeration estimates correlated closely with the confirmatory methods.

中文翻译：

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在一项国际多中心试验中评估 MYCOPLASMA IST3 泌尿生殖支原体检测

目的 评估支原体 IST3 的准确性、易感性和特异性，这是下一代最流行的基于培养的体外诊断设备，旨在检测、识别和测试泌尿生殖道支原体感染的易感性。方法 MYCOPLASMA IST3 针对基于培养和分子的金标准方法进行评估，以检测、鉴定、枚举和确定在法国、塞尔维亚和英国收集的 516 个临床样本中人支原体和解脲脲原体的抗菌素耐药性。样本类型包括外阴阴道/宫颈管或尿道拭子（干拭子或 eSwab®）、精液和尿液样本，其中包括添加一组 80 个特征对照菌株后的盲法分析。结果 两种解脲脲原体的总体物种鉴定都非常好。（98.4% 的灵敏度，99.7% 特异性）和人型分枝杆菌（95.7% 敏感性，100% 特异性）相对于琼脂和定量 PCR 标准上的组合菌落形态。如果±10 倍的方差为允许）相对于琼脂上计数的菌落。Ureaplasma spp 的抗性准确度。与金标准不同，只有 11/605 的单独测试（主要错误率 = 1.8%）和 14/917 的人型分枝杆菌单独测试（主要错误率 = 1.5%）。结论 重新设计的支原体 IST3 检测通过提供独立准确的人支原体和解脲脲原体抗性筛查，即使在混合感染中，也消除了以前的缺点，具有符合 CLSI 的阈值。特异性，