The Evaluation Of Precision Research Of The Hepatitis B Core Antibody By EP5-A2

Objective:Antibody of second liver core respectively detect by manual and automatic ELISA assay, evaluate its precision problem and comparing their advantages and disadvantages.Method:Referring to the Clinical and Laboratory Standards Institute(CLSI) EP5- A2 file,select two concentrations(high value and low value) experimental samples. Records and collates data, through the Excel to calculate the within-run imprecision 、 within day imprecision、total imprecision respectively.Result:After the research two groups of high and low data are obtained. Manual method HBc Ab value low(L): The within-run imprecision was 3.3%, the within day imprecision was5.0%, the total imprecision was 6.3%. Manual method HBc Ab value high(H): The within-run imprecision was 3.1%, within day imprecision was1.5%, total imprecision was4.1%. Instrument method HBc Ab value low(L): The within-run imprecision was 2.5%, the within day imprecision was3.0%, the total imprecision was4.4%. Instrument method HBc Ab value high(H): The within-run imprecision was 1.1%, within day imprecision was1.2%, total imprecision was2.7%.Conclusion:Using the manual and automatic ELISA analyzer two kinds of methods to detect HBc Ab within-run imprecision are less than a quarter of EA、the within day imprecision are less than a third between EA、total imprecision always are less than declared value. By this experiment scheme evaluation always don’t belong to the ideal level, precision of the detection system stability is higher, the repeatability is good. Methods and instruments are used in the lab can satisfy clinical normal use, the use of ADC analysis system has reached the factory requirements, evaluation of the precision of the experiment EP5- A2 file operation is simple, affordable.