Development of Test Materials to Evaluate In Vitro Diagnostic Device Performance for the Determination of Calcium, Creatinine, Digoxin, Glucose and Potassium in Serum

摘要

A procedure was developed to evaluate clinical chemistry in vitro diagnostic products and to rapidly screen for inaccuracies using interrelated specimens. The devices evaluated are used for the determination of calcium, creatinine, digoxin, glucose and potassium in serum. The study suggests that this screening procedure may provide a useful preliminary step in identifying products warranting further evaluation by more rigorous test procedures. Data obtained through this evaluation correlated well with data obtained using recognized reference methods.