Analyte Stability in Clinical Chemistry Quality Control Materials

Abstract

Maximum stability of analytes in chemistry control materials is desired. Stability testing is customarily performed by manufacturers, both prior to distribution of products and during the period following distribution when the products are in the field. Users and evaluators of such materials periodically have reported on experienced stability of various analytes in distributed manufactured products. A wide variety of both testing protocols and definitions of acceptable stability have characterized published reports on the topic. In the present review, we summarize published studies on control material stability in clinical chemistry, review criteria employed to define instability, and present an approach to evaluating stability of analytes involving both statistical and clinical criteria.

Stability of Lyophilized Human Serum for Use as Quality Control Material in Bhutan

“…The variety of statistical approaches used to assess stability also affects the stability results. It has been reported that about 5 % of the results are expected to show instability due the choice of the statistics [16]. Therefore, recommended alternate approaches to using statistics in order to provide useful information depending on the nature and frequency of the measurement.…”

Emerging contaminants detected in aquaculture sites in Java, Indonesia

“…We also studied the analyte stability. The definition of stability was a measured change in the concentration of analytes by the given method (Lawson et al, 1982). In the present study, we examined the effect of the selected acidic modifier concentration in the mobile phase on the stability of target compounds.…”