M46CN Campylobacter乳胶凝集试验检测弯曲菌的评价

Evaluation of M46CN Campylobacter latex agglutination test for detection of Campylobacter spp.

目的评价M46CN Campylobacter乳胶凝集试验检测弯曲菌的性能。方法用M46CN Campylobacter乳胶凝集试验,对临床373份粪便标本和48h培养后培养物进行直接检测和鉴定,以API CAMPY生化鉴定结果为标准,评价M46CN Campylobacter乳胶凝集试验对标本直接检测和培养物鉴定结果的性能。结果 M46CN Campylobacter乳胶凝集试验对373份粪便标本进行直接检测,阳性61例,阴性312例,其检测灵敏度为80.8%,特异性为99.3%,阳性结果预示值为96.7%,阴性结果预示值为95.5%,检测效率为95.7%。与标准方法鉴定结果相比,经Kappa一致性检验,Kappa=0.8547】0.75,u=16.5961,u】u0.01/2,P【0.01,具有统计学意义。对373份粪便标本培养物进行鉴定,阳性73例,阴性300例,其检测灵敏度、特异性、阳性结果预示值、阴性结果预示值和检测效率均为100%。结论 M46CN Campylobacter乳胶凝集试验对粪便标本直接法检测结果与标本培养后标准生化鉴定结果具有良好一致性,对培养物中弯曲菌鉴定结果与标准的生化鉴定结果完全符合,其灵敏度和特异性高,适合临床常规鉴定嗜热弯曲菌使用。

Objective To evaluate the performance of M46CN Campylobacter latex agglutination test in detecting Campylobacter species.Methods 373 clinical faecal samples and their cultures were both tested by M46CN Campylobacter latex agglutination test,whose performance was evaluated with the API CAMPY indentification results as a standard.Results Of the 373 clinical faecal samples,61 were positive and 312 were negative,the sensitivity,specificity,positive prevalue,negative prevalue and detection efficiency were 80.8%,99.3%,96.7%,95.5%,and 95.7%,respectively.Compared with the satandard method,the results of the consistency test showed as follows:Kappa=0.8547>0.75,u=16.5961,u>u0.01/2,P<0.01,which had statistical significant.Of the 373 cultures,73 were positive and 300 were negative,the sensitivity,specificity,positive prevalue,negative prevalue and detection efficiency were all 100%.Conclusion M46CN Campylobacter latex agglutination test for direct detecting Campylobacter species in faecal samples has good consistency with the API CAMPY test.Furthermore,its results for faecal cultures can be 100% exact match with the API CAMPY test.Because of the high sensitivity and specificity,it is useful to identify thermophilic Campylobacter species for clinical microbiological laboratory.