| Blood cell analysis,commonly known as blood routine examination,is one of the most basic clinical tests.The main items of.blood cell analysis included white blood cell count,red blood cell count,hemoglobin concentration,hematocrit,platelet count,white blood cell classification and reticulocyte.The results of analysis can find many signs of systemic diseases,which can provide evidence for clinical judgment of anemia,infection,hematological diseases,bone marrow hematopoietic function and so on.At present,the clinical test are tested by automated instruments,but different brands,different types of instruments or different laboratory tests can result in different results of the same sample,which may also affect the diagnosis,treatment and prognosis of the disease.Therefore,in order to realize the comparability and accuracy of the results of blood cell analysis,the standardization of blood cell analysis is of great significance.At present,the International Committee for Hematology Standardization(ICSH)and the World Health Organization(WHO)have issued reference methods for blood cell analysis,including white blood cell count,red blood cell count,hemoglobin concentration,hematocrit and platelet count.China has also issued the corresponding health industry standards,in order to promote the traceability of the results of blood cell analysis,and to achieve the accuracy and comparability of the results measured by different instruments in different laboratories.However,there are more than 150 manufacturers of hematology analyzer in clinical laboratories in China.How to standardize the measurement results is the bottleneck of the development of blood cell analysis and measurement at present.This paper discusses the use of fresh blood samples to verify the accuracy of the test results in the region and its application in the traceability of the value of the manufacturer.Objective:Through the establishment of the reference method of blood cell analysis,this paper discusses the traceability of the value of blood cell analysis and realizes the standardization of the measurement results.The accuracy of the reference method was investigated in the region,and the accuracy of the reference method of blood cell analysis in the region was evaluated,which can provide domestic manufacturers with blood cell analysis value traceability service.Methods:According to the reference method document of blood cell analysis recommended by the International Committee for Hematology Standardization(ICSH)and the World Health Organization(WHO),combining with the requirements of Chinese health industry standards,the reference method of blood cell analysis was established.The precision,accuracy,linear range,carrying pollution,other analytical properties and uncertainty were evaluated.1.Using the interoperable fresh whole blood as the test sample,the accuracy verification plan between regions was carried out,and the quality management model of standardizing the measurement results of the testing system among regional medical institutions was discussed.2.By establishing the reference method of blood cell analysis and cooperating with the production of instrument and reagent,which can provide fresh whole blood assignment service and calibration service for manufacturers and value tracing service for manufacturers from the third party quality management and save resources.Results:1.Performance evaluation:the analytical performance of 5 blood cell analysis and measurement items(WBC,RBC,PLT,Hct,Hb)all met the requirements of the reference method.The uncertainty is as follows:RBC:(4.17±0.07)×1012L(k=2);WBC:(9.11±0.22)X 109/L(k=2):PLT:(204±5.3)×109/L(k=2);Hb:(148.6±0.96)g/L(k=2);Hct:(38.04±0.0061)%(k=2),which shows that our laboratory has successfully established a reference method for blood cell analysis.2.Applied research:?According to the evaluation criteria of the Clinical Laboratory Center of the Health and Health Commission:there are 2 equipment in sample 1 exceeded the allowable range and 1 device in sample 4 Hct exceeded the allowable range,with a total qualified rate of 99.5%(657/660).According to the CLSI recommendation,the number of unqualified WBC projects is 14,the number of unqualified RBC projects is 19,the number of unqualified HGB projects is 3,and the number of unqualified Hct projects is 32,the number of unqualified PLT projects is 2,and the total qualified rate is 89.4%(590/660).Most of the items of different brands of instrument measurement results are compared,the difference is statistically significant.?The fresh whole blood samples were used to calibrate and verify by the Z3 and Z5 automatic blood cell analyzer of a domestic company.The results were satisfactory.Conclusion:The reference method of blood cell analysis has been successfully established in our laboratory and its performance meets the requirements.The establishment of this reference method is helpful to establish a verification plan for the accuracy of blood cell analysis and measurement in interregional clinical laboratories.It can also provide value tracing service for the manufacturer of hematology analyzer... |
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