Clinical Performance Study Of A New Fully Automated Red Blood Cell Permeability Fragility Analyzer And Its Application In Thalassemia Screening

ObjectiveTo study the clinical performance of the RA-800 fully automatic erythrocyte permeability analyzer(scattering turbidimetric method).The value of the EFT test in combination with the primary screening indexes of MCV,MCH and Hb electrophoresis for screening thalassemia was investigated.MethodsA total of 100 cases of suspected thalassemia patients from the People’s Hospital of Luohu District performing pregnancy were studied.The clinical diagnosis supported by genetic testing was used as the gold standard,while the automatic red blood cell permeability fragility analyzer RA-800 was used to compare with the existing KOFA erythrocyte fragility test(direct colorimetric method)kit system used in the clinical laboratory.A total of 220 patients diagnosed with thalassemia from the People’s Hospital of Luohu District were used as the observation group,and 220 healthy people were used as the control group during the same period.MCV,MCH,Hb electrophoresis test and EFT were detected in the patients’ blood.Then their sensitivity,specificity,positive predictive value,negative predictive value,and correct rate were analyzed and compared.ResultsThe sensitivity,specificity and correct rate of the new automatic red blood cell permeability fragility analyzer RA-800 screening for thalassemia were 66.67%,92.86%and 85.00%,the KOFA direct colorimetric method were 76.67%,81.43% and 80.00%.The Kappa test value of both methods for the screening of thalassemia was 0.558,which concluded that the consistency was moderate.The ROC curve indicated that both two methods had diagnostic significance for the diagnostic value of thalassemia.The positive rates of MCV,MCH,Hb electrophoresis,EFT and the four combined tests of the observation group were higher than that in the control group,and the differences were statistically significant(P<0.05).The sensitivity,negative predictive value and accuracy of the four combined tests were higher than those single screening of MCV,MCH,Hb electrophoresis and EFT,the differences were statistically significant(P<0.05).ConclusionThe new automatic red blood cell permeability fragility analyzer RA-800 is suitable for thalassemia screening,and the performance indexes meet the clinical requirements.The combined screening of MCV,MCH,Hb electrophoresis and EFT can effectively improve the positive detection rate and diagnostic accuracy of thalassemia.Figure [1] table [4] reference [28]...