[Control of accuracy of immunoserological laboratory data on medical network and standardization].

ABSTRACT

Construction of a medical network for each region and organization has become possible by utilization of information technology. Standardization of the data on the medical network is urgent. Especially, the standardization of immunoserological data is much delayed. In this study, the possibility of standardization of such data was reconsidered based on the findings from various control surveys. Regarding the measurement items for serum concentrations of proteins and other compounds, we concluded that standardization should occur in a manner similar to the method for standardization of biochemical data and accurate control. The data on CRP, IgG, IgA, IgM and AFP, which are determined using the respective standard compound, were converged to a range with inter-facility differences of less than 10% CV. The data on CEA were also converged to achieve an inter-facility difference of less than 10% CV through repeated survey. Automatic measurement for the markers of infection diseases has progressed, and the expression of measurements was changed to the absolute value of COI, U/ml or IU/ml although it was titer in the past. Since these expressions now coexist, it is impossible to standardize the data with absolute qualitative values. It seemed necessary to present them uniformly with qualitative or clinical criteria values or express the presence or absence of infection by a combination of related markers. The measurements obtained from autoantibody-related tests using identical reagent were found coincident, but measurements obtained using different reagents were discrepant and the differences were greater than the sensitivity of measurement. In immunoserological testing and immunochemical testing, it is most important whether the antigen/antibody used as the reagent is the same preparation or not. Therefore, the test should be reconsidered through setting a certain restrictions on each recognition site of epitope and antibody. Thus, we concluded that use of a suitable standard substance is effective for standardization of immunological data.