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目的比较5种艰难梭菌检测方法并进行评价。方法包括tcdB基因PCR检测、tcdB基因Real-time PCR检测、酶联免疫法、酶联免疫层析法以及环丝氨酸-头孢西丁-果糖琼脂(CCFA)常规培养法。以CCFA培养的检测结果作为参考,对以上几种方法进行评价。结果得到上述检测方法的敏感度、特异度、阳性预测值和阴性预测值结果以及其与参考方法的Kappa值。在125例样本中,CCFA培养法检出阳性标本11份,tcdB基因普通PCR检测、tcdB基因Real-time PCR检测、酶联免疫法、酶联免疫层析法分别检出阳性12、12、50和25例,4种方法间检出阳性率差异有统计学意义(χ~2=61.452,P<0.000 1),敏感度分别为63.64%、63.64%、63.64%和54.55%,差异无统计学意义(χ~2=0.288,P=0.962);特异度为95.61%、95.61%、62.28%和83.33%,差异有统计学意义(χ~2=63.597,P<0.000 1)。结论 PCR方法敏感度、特异度最高,成本较低,适用于有实验条件的流行病学调查和临床诊断,两种免疫方法试剂盒适用于临床先期筛查以及辅助诊断。
Objective To compare and evaluate five kinds of detection methods of Clostridium difficile. Methods include tcdB gene PCR detection, tcdB gene Real-time PCR detection, enzyme-linked immunosorbent assay, enzyme-linked immunochromatography and cycloserine-cefoxitin-fructose agar (CCFA) routine culture method. CCFA cultured test results as a reference, the above methods were evaluated. Results The sensitivity, specificity, positive predictive value and negative predictive value results of the above test methods and their kappa values with reference methods were obtained. In 125 samples, 11 positive samples were detected by CCFA culture method, tcdB gene common PCR detection, tcdB gene Real-time PCR detection, enzyme-linked immunosorbent assay and enzyme-linked immunosorbent assay were positive 12,12,50 And 25 cases, the positive rates of the four methods were statistically significant (χ ~ 2 = 61.452, P <0.0001), the sensitivity was 63.64%, 63.64%, 63.64% and 54.55%, respectively, with no statistical difference (Χ ~ 2 = 0.288, P = 0.962). The specificity was 95.61%, 95.61%, 62.28% and 83.33%, respectively. The difference was statistically significant (χ ~ 2 = 63.597, P <0.0001). Conclusion PCR method has the highest sensitivity, specificity and lower cost. It is suitable for the epidemiological investigation and clinical diagnosis with experimental conditions. The two immunological methods are suitable for clinical preclinical screening and diagnosis.