Study On Feasibility Of Chinese Domestic Clinical Laboratory Instrument Under The Policy Of Mutual Recognition Of Clinical Laboratory Result

Objective:Through the comparison between examination results of two hematology analyzers produced by foreign and Chinese medical instrument company,the paper tries to discuss the commutability and traceability and finally provide some references for the improvement of mutual recognition of medical test results among hospitals and medical institutions of different tiers in Shanxi province.Methods:By taking some tertiary hospital as an example,the paper randomly chose 300 patients who received routine blood test in clinics or hematology department in November2015.According to the professional standard,quality requirement,and sample requirement of clinical hematology test items,the study chose the patients from the 300 patients for each blood test items.The paper used French ABX Pentra DF120 and Chinese Mindary BC-5500 to do the routine blood tests,then compared the test results analysed by the two hematology analyzers,finally evaluate the commutability and traceability of Chinese Mindary BC-5500.Results:This study was strictly abide by the minimum sample and normal and abnormalconcentration in National Health Standard of the People's Republic of China(WS/T406-2012)and ensured that the bias of different blood tests met the clinical medicine limitation.That is to say,the sample collection,blood test process,laboratory environment were completely in accordance with the blood test standard.Therefore,the result of this study was valid,credible,and referable.Firstly,in the following four parts,which were carryover,precision,linearity,bias,the French ABX Pentra DF120 passed the examination and showed good quality,the test result was satisfied.The study chose the French ABX Pentra DF120 as referenced instrument feasible for this hematology analyzer was stable and precise in the blood cell test.Secondly,the commutability examination between French ABX Pentra DF120 and Chinese Mindary BC-5500 in WBC?RBC?HGB?MCV?HCT?PLT?MCH?MCHC tests was eligible.It is proved that Chinese Mindary BC-5500 had qualified commutability,universal blood test results,and high precision.Conclusion:Through the comparison between French ABX Pentra DF120 and Chinese Mindary BC-5500 in blood cell analysis,the paper holds that the two hematology analyzers have good commutability in their blood test results.Given the current implementation of Chinese clinical laboratory result mutual recognition policy,the paper convinced that promotion of Chinese domestic clinical laboratory instruments is preferable.Based on the result of this study and the present problems of Chinese clinical laboratory result mutual recognition policy implementation,the paper suggest that the relative department should expand the policy coverage,gradually realize the mutual recognition among different tiers hospitals,promote the domestic medical instruments,build the medical information-based platform,issued more regulations and supporting policies to guarantee the interest of the public,strengthen the technique and skill training of laboratorians,establish the standardized clinical test process,and make professional communication regularly to help medical staff learn and get more updated theories andmethods.