【摘要】 目的临床评估8种支原体(Uu)液体培养试剂盒(Kit)的质量。方法 6家性病实验室的技术人员,在同一条件下,分别用8种试剂平行双盲检测100份临床样本。以A7固体培养结果为标准,分析各试剂的敏感性、特异性、总功效率。结果 8种Kit检测Uu的敏感性从73.2%～100%不等,其中Kit6、7、8的敏感性低于85%,显著低于固体培养法(P<0.01)。Uu检测的特异性显示:5种Kit达95.4%～100%,而Kit2、4、8为77.3%～86.4%,显著低于固体培养法(P<0.05)。人型支原体(Mh)检测的敏感性较高(80.4%～97.8%),只有Kit9的敏感性(80.4%)显著低于固体培养法(P<0.01),漏检率为19.6%。Mh检测的特异性均达96.3%以上。10份抑菌效果实验显示:所有试剂均能100%抑制杂菌生长。结论部分国产试剂已等同或接近国外试剂,但试剂的性能指标存在差异,临床检测应用时应注意。更多还原

【Abstract】 Objective To evaluate the quality of 8 commercially available kits for detecting mycoplasma by liquid culture method.Methods Technicians from 6 laboratories evaluated 8 commercially available kits for detecting mycoplasma by double blind test.A total of 100 clinical specimens were detected in parallel.Sensitivity,specificity and efficiency of each kit were analyzed by comparing with agar culture which was used as the gold standard.Results Among the 8 kits evaluated,the sensitivity of Ureaplasma urealyticum(Uu) detected by 8 kits was from 73.2% to 100%,of which kit 6,7 and 8 were below 85%,significantly lower than that with the agar culture(P<0.01).The specificity was 95.4% to 100% by 5 kits,while that by kit 2、4 and 8 was 77.3%-86.4%,significantly lower than that with the agar culture(P<0.05).the sensitivity of Mycoplasma hominis(Mh) detection was proved to be higher(89.1%～97.8%)for all kits,except for kit 8(80.4%),which was significantly lower than that with the agar culture(P<0.01);the specificity of Mh detection was all more than 96.3%.Bacteria inhibition tests showed 100% bacteria growth inhibition by all kits.Conclusions Performance of some domestic kits was similar or equal to that of the imported ones,but differences were found in quality parameters among some kits.The results were helpful in clinical detection of mycoplasma.更多还原