Research and Development to Promote the Creation and Utilization of an Intellectual Infrastructure.
Development of Reference Materials for Laboratory Medicine (FY2006) Final Report
There is a great demand to establish the metrological traceability system from routine measurement data to higher order reference materials in the IVD-MD (in vitro diagnostics and medical devices) in the clinical medicine, because the clinical testing data, which are obtained with different reagents or measurement procedures in different laboratories, have not always comparability with each other. The comparability with the clinical testing data allows the effective use in nationwide, the improving medial treatment and consultation, and the long term record of the individual clinical laboratory data. It is the traceability that ensures the comparability among the clinical testing data obtained from different laboratories. In this study, several types of reference materials for laboratory medicine are developed in order to establish the traceability. Firstly, about 20 kinds of matrix reference materials as secondary reference materials, which are very important for diagnostic of first medication, endocrine disease, coronary disease, diabetes and so on, are going to be developed in 3 years. This year, we developed the matrix reference materials such as total calcium, total magnesium, iron in serum, urea, blood gas, ionized calcium, glycoalbumin, hemoglobin A1c (HbA1c), cholinesterase, albumin, amylase, C reactive protein (CRP), HDL-cholesterol, LDL-cholesterol, insulin, C-peptide, cortisol and lipase. In the case of the first 8 analytes, their prototypes of reference material have been developed, and for the other analytes, specifications of the characteristics of the reference materials have been notified, and the measurement procedures for the determination of certified values of reference materials have been studied. Moreover, the standardization of the electrolytes and biochemical components of urine started to develop their routine available matrix reference materials used as manufacturer's calibrators. The routine available reference materials of inorganic phosphorus, lithium and total bilrubin were also investigated. Secondly, the highest order certified reference materials of CRP is developed as a primary reference material, whose protein characterization is performed with the analytical methods such as an isotope dilution analysis, an amino acid and a nitrogen analysis. The recombinant human CRP is selected as a candidate reference material and the analytical performances of the above methods were minutely determined. Thirdly, feasibility study to develop matrix reference materials of screening tests of laboratory medicine is carried out. This year, we investigated the possibility of standardization for rheumatoid factor (RF), digoxin, theophylline, prolactin (PRL), luteinizing hormone (LH), follicle-stimulating hormone (FSH), estradiol (E2), thyroid stimulating hormone (TSH), thyroxine, thyroglobulin,β2-macroglobulin, human chorionic gonadotropin (hCG), α-fetprotein(AFP), carcinoembryonic antigen (CEA), and ferritin. As a result, it is found that establishment of the consensus standards of the following items is very useful for the comparability of laboratory data; RF, digoxin, PRL, E2, TSH, hCG, AFP, CEA, and ferritin.
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