Testing Performance And Cost Analysis Of Five TB Laboratory Testing Methods Applied In Medical Institutions

Objective: Tuberculosis is an infectious disease caused by Mycobacterium tuberculosis.It is one of the most concerned public health issues.It is a widespread disease,especially in developing countries,and is harmful to human health.Timely detection and proper treatment of can reduce the impact of personal health,reduce the spread of disease,and have a great positive effect on disease prevention.Rapid and accurate diagnostic methods directly affect the reporting rate of tuberculosis,thus affecting disease transmission and patient management,which is the basis for controlling tuberculosis incidence.Common traditional laboratory diagnostic methods include manual smear staining microscopy(manual smear),sputum Mycobacterium culture and so on.In recent years,automated whole smear microscopy(automatic smear)and molecular diagnostic techniques(including Gene Xpert MTB/RIF(Xpert)and loop-mediated isothermal amplification fluorescence)were appear,which provided new ideas for laboratory diagnosis of tuberculosis.Analyzed the accuracy,detection time,operation and cost of manual smear,automatic smear,liquid culture and constant temperature fluorescence amplification.According to the characteristics of medical institutions,the detection methods suitable for primary laboratories in China were determined.The purpose of this study is to provide the basis for clinical work to select appropriate tuberculosis diagnosis methods.Methods: There were 735 suspected TB patients in this study.Collected 3 sputum samples with a total amount at least 6 ml,then mixing and detection.Taking the final diagnosis result of clinicians as the gold standard,comparing the differences of sensitivity,specificity and coincidence rate of several techniques,collecting the cost information of each technical instrument,equipment,reagent consumables,number of personnel,and considering the accuracy,detection time,operation difficulty and cost of each technique synthetically,judging the detection method suitable for medical institutions in China.Use Excel 2010 to collate the results and cost data,then use SPSS22.0 to analyze the data statistically(Kappa).Prescribed inspection level α as 0.05.Results: Based on the diagnostic criteria,sensitivity of manual smear,automatic smear,liquid culture,Xpert,loop-mediated isothermal amplification fluorescence were53.20%,38.92%,67.49%,85.47%,78.57%,respectively;Kappa was 0.53,0.36,0.65,0.84,0.77(P <0.001),The average detection time was 0.74 h,0.78 h,1.63h+6 weeks,0.45 h,0.22h;The average cost of a specimen was ￥42.75,￥61.81,￥543.39,￥467.45,￥200.51;The cost of correctly detecting a patient was ￥145.47、￥287.52、￥1457.63、￥990.14、￥ 462.00.In this study,manual smears are consistent with automatic smears,The coincidence rate was 91.02%,Kappa=0.77(P < 0.001).The coincidence rate was80.54%,78.91%,Kappa was 0.61,0.56(P <0.001),and the coincidence rate was 90.75%and Kappa was 0.81%(P <0.001).Conclusion: In this study,the five techniques have their own advantages and disadvantages in detecting tuberculosis.The consistency with diagnostic standards ranges from high to low: Xpert,loop-mediated isothermal amplification fluorescence,liquid culture,manual smear,automatic smear.The detection time from short to long:loop-mediated isothermal amplification fluorescence,Xpert,manual smear,automatic smear,liquid culture.Cost from low to high: manual smear,automatic smear,loop-mediated isothermal amplification fluorescence,Xpert,liquid culture.Choose the appropriate TB testing method according to your own needs to improve the efficiency of testing.