The stability is mainly affected by storage time and also by other factors that increase the metabolism of the analyte or cause the initial property to disappear, such as temperature, light exposure, solvent evaporation or stirring. Stability is the capability of a sample material to retain the initial property of a measurand for a period of time within specified limits when the sample is stored under defined conditions. Definition of a consensus stability function in specific conditions can help laboratories define stability limits using their own quality specifications. Bibliographic studies differ in recommedations of stability limits mainly because of different specifications for maximum allowable error. Time is the main variable affecting stability in medical laboratory samples. Consensus stability equations were established for glucose, potassium, phosphorus and PSA, but not for ALT. Results:įrom the 37 articles considered as valid, up to 130 experiments were evaluated and 629 PD% data were included (106 for ALT, 180 for glucose, 113 for phosphorus, 145 for potassium and 85 for PSA). Second, the different conditions of stability were uniformly defined and the percent deviation (PD%) over time for each analyte and condition were scattered while unifying studies with similar conditions. The quality of every study was evaluated using an in-house grading tool. Methods:įirst, a bibliographic search was made for stability studies for five analytes in blood: alanine aminotransferase (ALT), glucose, phosphorus, potassium and prostate specific antigen (PSA). The aim of this study was to classify and to grade a set of bibliographic studies on the stability of five common blood measurands and subsequently generate a consensus stability function. Many studies assessing stability and presenting recommendations of stability limits are available, but differences among them are frequent. The stability limit of an analyte in a biological sample can be defined as the time required until a measured property acquires a bias higher than a defined specification.
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