Article,

The nature of calibrators in immunoassays: are they commutable with test samples? Must they be?

, and .
Scand.J.Clin.Lab Invest Suppl, (1991)

Abstract

Immunoassay systems require calibration protocols that are normally more sophisticated than many analytical techniques in routine clinical use. Calibrators used in such assays may differ significantly from the analyte in clinical specimens. Differences in the properties of calibrators, or reference materials, from those of clinical specimens may include: species origin of the calibrator for an analyte; integrity of the molecular species; matrix of the calibration solution; addition of preservative agents. Owing to the large number of potential differences in the properties of calibrators and those of serum specimens that may affect immunoassay results, the concept of commutability that we originated and first applied to enzyme activity measurements can readily be applied to immunoassay determinations. We specifically examined the properties of calibration materials in nine commercial immunoassay tests for human thyrotropin. Significant non-commutability of materials was demonstrated. T

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