임상화학 정도관리물질들의 안정성 평가

Abstract

This study was carried out to evaluate the stability of commercial lyophllized control meterials being used for clinical chemical test and to investigate the substitutivity of a pooled serum prepared in our laboratory for those materials. Five sets of commercial lyophllized control meterials including normal and abnormal levels were obtained from five different manufacturers and stored under different conditions of storage(room temp., refrigeration at 6ºC or freezing at 20ºC). They were analyzed together with a pooled serum by Hitachl 7150 automated chemisσy analyzer and NOV A4+ electrolyte analyzer for the determination of 20 clinical chemical parameters and 3 electrolytes. The CV of within-batch, inter-batch and between-day in the precision analysis were below 1.3, 1.6 and 4.6%, respectively. It was revealed that total protein, albumin, creatinine,BUN, total cholesterol and TG were stable and their CV was less than 5% whlle total and direct bilirubin were unstable at room temperature and upon light exposure with CV of 0.8∼27.5 %. ALP at room temperature was also unstable. It was also revealed that pooled serum has no significant difference from those commercial control materials. The results above suggest that pooled serum could be used as a substitute for the commercial control materials with low cost.