by Robert Janetschek, MSc, MT(ASCP)
Considering the varied, and often critical biochemical roles that enzymes play in human pathology and physiology, it is not surprising that their analysis includes some of the most frequently performed tests within the laboratory. As such, it is vital for the laboratory to have access to a supply of clinical reference materials that are primarily focused on enzyme components. For purposes here, such materials are designed and utilized for the calibration verification of instrument systems, as well as for the validation testing of new clinical assays, instrumentation, and a host of other medically oriented products. Access to independent validation tools such as these are vital for the determination of an enzyme method’s overall accuracy, linearity, sensitivity, measurement range and other performance characteristics, as required under a number of current regulatory mandates.
Based upon the input, recommendations and suggestions obtained directly from laboratorians in routine clinical and research-oriented facilities, as well as regulatory agencies, it is desirable that these enzyme verification materials contain the following product attributes and the primary reasons why:
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