Analysis On The Test Results Of Drug Sensitivity Test In China 's Tuberculosis Laboratory

Part ⅠAnalysis of anti-tuberculosis drug susceptibility testing proficiency test 2009-2014, in China.Objective To assess and analyze the results of nationwide proficiency test of anti-tuberculosis drug susceptibility testing(DST), to define the pass and excellent criteria for first-line and second-line DST proficiency test, to find the problems and solutions for the lab with bad DST performance, and through focused training, supervision, and internal quality control to improve the capability of tuberculosis laboratories in China.Methods Nationally there were a total of 845 provincial and prefecture level TB laboratories capable of DST. The national tuberculosis reference laboratory issued 30 mycobacterium tuberculosis isolates for the DST proficiency test to each participating laboratories yearly from 2009 to 2014. The laboratories performed DST for isoniazid(H), streptomycin (S), ethambutol(E), rifampicin(R), kanamycin (Km), amikacin (Am), capreomycin (Cm)and of loxacin (Ofx) using the proportion method in Lowenstein-Jensen medium, the World Health Organization and national guideline was strictly followed. A total of 845 laboratories reported the results of first line DST, and 774 laboratories reported the results of second line DST. The reported results were checked and compared by national tuberculosis reference laboratory. SAS 9.4 software was be used for statistical analysis. The evaluation index is sensitivity, specificity, reproducibility, efficiency and Kappa coefficient of consistency. The chi-square test was be used to analyze the difference, and the Cochran-Armitage trend test was be used to describe the trend results. The city-level efficiency results between 2012-2014 were compared with four tables of Chi-square test, significant difference was defined as P<0.05.Results There were significant difference between 2009-2014 on the overall value of sensitivity, specificity, reproducibility and efficiency for H, S, E, R and Of x (P<0.01). Each index has an improving trend, with a statistically significant trend (P<0.01). Except for the reproducibility of Km and Cm was not statistically significant difference between each year, the difference of other indexes for each drug between each year was statistically significant(P<0.01); While, except for the overall sensitivity of Cm, the overall reproducibility of Am and Cm, other indexes all showed a trend of increase by year (P<0.01). There were still different degrees of unqualified results, among them, S and Am had lower percentage of unqualified, E and Cm had high percentage of unqualified. These percentages of the other four drugs were between 7.69%-8.76%. The efficiency results of the various drugs in each laboratory were mostly concentrated in 80%, only E, Cm concentrated in 70%-80%. In the 2009-2014 proficiency test, the annual total drug sensitivity of the H(except 2014), E, R, Km, Am (except 2010), Cm (except 2010), Ofx are all lower than total specificity value, only the S (except 2010) total sensitivity is higher than total value of specificity. The efficiency results of more than 80% of 32 provincial tuberculosis laboratories are above average-1 standard deviation. By comparing the Kappa coefficient, we selected 7 excellent laboratories. Either in TB dispensaries or in medical care institutions, even at city level or at provincial level, the efficiency had no significant difference compared to the overall city level (P>0.05) Conclusion Proficiency testing was an efficient method to improve the capacity and performance of DST, PT has made a great contribution to improve the ability of DST in Chinese TB laboratory network, and continuously conducting the laboratory internal quality control and carrying out personnel training to perform proficiency testing could increase the laboratory capabilities of DST year by year.Chinese proficiency test passing line:H, R, Km, Am, Cm, Ofx efficiency should reach 90%, S and E should reach 80%. additionally, we recommend excellent 96.67% excellent PT line for H, R, Km, Ofx while 90% for S, E, Am and Cm.Innovation:We defined PT test passing and excellent lines for China TB DST evaluation. We also developed auto-calculator to monitor the PT test results with Office Excel.Limitation:We still need to test our products by performing more PT tests. More researches are needed to improve DST quality control in China.Part ⅡEstablishing constant function based proficiency test results comparison system of anti-TB drug-sensitivity testObjective:To establish the results comparison analysis on the national network of TB laboratories participating in the anti-TB drug-sensitivity test proficiency test.Methods:Database function, logic functions, lookup and reference functions, statistic functions, text functions and custom functions were used in Excel2003 software to set up automatic interpretation modules for results comparison and analysis.Results:Through appropriate Excel2003 software function set, we could obtain the drug resistance rate(%), sensitive detection rate(%), concordance rate(%), repeatability rate(%), missing value, and the wrong results can be highlighted with the colors. And eventually to summarize the laboratory results.Conclusions:Excel2003 is powerful software for data analysis function, it is worth to use in lab comparison analysis.Innovation:Established the automatic comparison methods for proficiency test results of anti-TB drug-sensitivity testingLimitation:The methods could not determine the performance level of laboratories; we will further conduct research in the following work.