基于CLSI-M43国际标准改良的Mycoview-AST试剂盒检测性能评估

目的 基于美国临床标准化协会(clinical and laboratory standards institute,CLSI)M43国际标准改进的泌尿生殖道支原体Mycoview-AST试剂盒检测性能评估。方法 以法国MYCOFAST^○Rrevolution支原体试剂盒为比对标准,用CLSI-M43规定的质控株和有关指标及60例临床标本对新改进的试剂盒性能进行评估。结果 Mycoview-AST试剂盒以质控菌株检测的药敏结果与MYCOFAST11^○Rrevolution试剂盒一致。60例临床标本,阴性标本37例,解脲支原体(Uu)阳性16例,人型支原体(Mh)阳性5例,Uu与Mh均阳性的标本2例。两种试剂盒Uu和Mh的鉴定结果一致。23例阳性标本的药敏结果共161个,与进口比对试剂MYCOFAST^○R比对,154个结果符合,药敏结果符合率为95.6%(154/161)。结论 基于CLSI-M43国际标准改进后的Mycoview-AST试剂盒检测性能与国际知名品牌MYCOFAST^○Rrevolution试剂盒相当。

Detection Performance Evaluation of the Mycoview-AST Kits That Was Improved Based on the International Standard CLSI M43-A

Objective To evaluate the performance of the Mycoview-AST kits,which was improved based on the international standard CLSI-M43.Methods Evaluated the performance of the improved kit with the control strains which were assigned by CLSI-M43 and 60 clinical specimens,compared with MYCOFAST^○R revolution kit as the standard.Results The results of the antibiotic susceptibility tests with the control stain were in accordance with that of MYCOFAST^○R revolution kit.In the 60 clinical specimens,the identification resultsof mycoplasma in these two kits were corresponding.The coincidence rate of theantibiotic susceptibility tests with the clinical specimens in these two kits was 95.6%(154/161).Conclusion The performance of the improved Mycoview-AST kits based on CLSI-M43 was equal to MYCOFAST^○R revolution kit.