Diagnostic Test Of Chlamydia Trachomatis Acid Detection Kit(Xpert)

ObjectiveTo evaluate and compare the diagnostic value of Xpert diagnostic kit(Multiple Real-time Fluorescence PCR)to detect Chlamydia trachomatis pathogen infection,to provide reference for the clinical disease detection and application of the kit.Methods1.The application of diagnostic test evaluation method,respectively calculate which kit and Cobas diagnostic kits urine sample and cervical swab sample CT sensitivity,specificity,correct,the predictive value of positive and negative,the likelihood ratio of positive and negative of index values.2.Use the McNemar test,ROC curve,t test and other statistical methods,the authenticity and applicability of Xpert kit and Cobas kit were compared and analyzed.3.The authenticity of CT was evaluated by series test and parallel test evaluation of Xpert kit and Cobas kit.Results1.Accords with a condition of this research into the group of urine sample subjects,a total of 331 cases,192 cases(58.0%)of women,male 139 cases(42.0%),aged 18 to68 years old,the average age was(32.0?8.5);A total of 248 cases of cervical swab sample,are women,aged 18 to 64 years old,the average age was(30.0?7.5).2.In the urine sample test results,which the kits,the sensitivity of CT was 98.2%,98.2%,the accuracy was 98.2%,the likelihood ratio of positive and negative were 54.6,0.018,while predictive value of positive and negative were 96.4%,99.1%,about the index of 0.964.Cervical swab sample testing sensitivity of CT was 94.6%,96.3%,and correct was 95.6%,the likelihood ratio of positive and negative were 25.6,0.056,while predictive value of positive and negative were 95.5%,95.6%,about the index of 0.909.3.In the detection CT of urine sample results,which kit sensitivity(98.2%)with Cobas kit sensitivity(96.3%)no statistically significant difference between(?~2=0.67,P=0.687).Which kit of the specific degree(98.2%)with the specific density of Cobas kit(99.5%),no statistical significance of differences between(?~2=1.80,P=0.375).Which with Cobas kit to detect CT under the area under ROC curve and the standard of the differences were statistically significant(P<0.05),but the two kits CT the difference between the area under the ROC curve of no statistical significance(P>0.100).In CT cervical swab sample test,which kit sensitivity(94.6%)with Cobas kit sensitivity(92.9%)no statistically significant difference between(?~2=0.33,P=0.774).Which kit of the specific degree(96.3%)with the specific density of Cobas kit(99.3%),no statistical significance of differences between(?~2=2.67,P=0.219).Which with Cobas kits under CT area under the ROC curve and standard differences also were statistically significant(both P<0.05),but the two kits CT of the difference between the area under the ROC curve is no statistical significance(P>0.100)between.4.What is the average length of a urine sample which the kits(110.7?1.0)minutes,Cobas kits to(193.0?1.7)minutes,which with Cobas kits required to complete a CT sample time difference statistically significant(t=-770.67,P<0.001);Cervical swab samples which is the average length of a kit to detect CT(110.7?1.1)minutes,the Cobas(193.0?1.7)minutes,which with Cobas time needed for the kits differences statistically significant(t=-656.71,P<0.001).5.The sensitivity and specificity were 94.5%and 100%in the urine sample Xpert+Cobas kit,while the predictive values of positive and negative were 100%and97.4%.The sensitivity and specificity of Xpert+Cobas kit in parallel diagnosis were100%and 97.7%respectively,while the predictive values of positive and negative were95.6%and 100%.Xpert+Cobas kit was used to diagnose CT,Xpert+Cobas kit in parallel,and the difference between the area under the ROC curve and the standard of the two kits was statistically significant(both P<0.05).Xpert alone detected the difference between the area under ROC curve of CT and the Xpert+Cobas kit in tandem diagnosis CT and parallel diagnostic CT method(P=0.141,P=0.303).The sensitivity and specificity of Xpert+Cobas kit were 88.4%and 100%respectively,while the predictive values of positive and negative were 100%and 91.3%respectively.The sensitivity and specificity of Xpert+Cobas kit in parallel diagnosis were 99.1%and 95.6%respectively,while the positive and negative predictive values were 94.9%and 99.2%respectively.Xpert+Cobas kit was used to diagnose CT,Xpert+Cobas kit in parallel,and the difference between the result of ROC curve and standard of two kits was statistically significant(both P<0.05).Xpert alone detected the difference between the CT and Xpert+Cobas kit in tandem diagnosis of CT,Xpert+Cobas kit in parallel diagnosis of CT and Xpert+Cobas kit.No statistical significance was found(P=0.189,P=0.704).ConclusionsThe sensitivity and specificity of Xpert kit were similar to that of the Cobas kit in CT detection of both types of samples,and the authenticity of Xpert kit was consistent with the Cobas kit.Xpert kit has high sensitivity and specific degrees,it is recommended as the laboratory test method for the pathogen of CT.