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  • With the development of laboratory medicine testing equipmen

    2018-10-22

    With the development of laboratory medicine, testing equipments are updated constantly, and the requirements for medical standards are gradually increased. With the increasing popularity of imported equipments in hospital, home-made facilities are increasingly replaced. In order to revitalize domestic enterprises and develop domestic industry, we should use more of domestic brands as long as the test results of domestic equipments can be consistent with those of imported ones. Because of the difference in instrument reagents, different standards, test procedures and maintenance programs, different instruments deliver different results of the same test parameters in different biochemical detection systems, which leads to incomparability of the test results between different instruments. There is currently no uniform standard for different international detection systems, while Luo Jun et al. used the 1/2CLIA88 predetermined allowable total error as the criteria for evaluation or as a reference for the feasibility and operability. Traceability and comparability of test results between different detection systems are important technical elements of the medical laboratory accreditation standard IS015189, which also emphasizes the comparison test as an important means to achieve the accuracy of traceability and comparability of test results. Reliability and punctuality of test results are quality requirements for clinical laboratories, so how to analyze the correlation and deviation between different biochemical detection systems has become an issue to be addressed in laboratory medicine. This study made a comparison and bias estimation of test results of the same testing program between automatic biochemical Roche cobas702 Results analyzers and home-made Mindray BS-2000M biochemical detection system according to NCCLS document EP9-A. This study showed that learn this here now each of the two instruments was highly accurate, the measurement range of the specimens selected was appropriate, and that the result of the correlation coefficient of the two biochemical detection systems was r2>0.95, p<0.01, indicating that the correlation between the two detection systems was quite good. As can be seen from Table 4, the relative deviation of TP at medical decision level 1 and medical decision level 2, TBIL at medical decision level 1 and P at medical decision level 3 was greater than 1/2CLIA88 allowable total error but not greater than CLIA88 allowable total error. The relative deviation of UREA and CREA at medical decision level 1 was also greater than 1/2CLIA88 allowable total, but absolute deviation was in the range of 1/2CLIA88 predetermined allowable total error. There was a recommendation in literature that the following criteria can be used to compare test results of the same test parameters detected by different detection systems: It is an appropriate standard that within the reference intervals of less than 1/2CLIA 88TEa and outside reference intervals of less than CLIA\'88Ea. These three errors which exceeded 1/2CLIA88 predetermined allowable total error did not exceed CLIA\'88Ea. So the system error between the two detection systems can be considered clinically acceptable and comparable. In addition, within the concentration range of home-made Mindray BS-2000M biochemical detection system claims, sixteen test parameters showed linearity at different gradient concentrations. Interference detection of sixteen parameters was conducted respectively. The anti-interference concentration of ALT to icterus and hemoglobin did not meet the requirements of claims, neither did the anti-interference concentration of AST and P to icterus, which might be ascribed to the concentration of the base sample and the pure product we used. The rest were in line with the manufacturer’s claim. Although the results of the sixteen conventional parameters were consistent with those detected by the imported automatic biochemical analyzer, the Mindray BS-2000M biochemical analyzer can still be used to detect many other biochemistry parameters, we should compare the results of the other parameters of biochemistry from now on.