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New Quality Control Systems for Every Laboratory Application


Betsy Donnelly, MT (ASCP)
Contributing Editor

Quality Control (QC) materials and procedures are key to meeting the needs of doctors and patients by verifying accuracy and precision of analytical methods. Vendors of these systems can be a valuable resource, designing customized QC materials and protocols to help lab managers ensure that analytical error stays within acceptable limits.

Developing suitable QC materials for today's laboratories is a demanding business. Although the ideal QC material must closely resemble the human sample, providing an equivalent matrix without unnecessary and potentially interfering preservatives, it must also be stable for long periods without special storage needs. It must be conveniently packaged and inexpensive. The material should be available with two or more different levels of analyte, to control the assay across the normal and abnormal range. It must contain known concentrations of the analyte, but it should not contain communicable disease agents. For convenience, a single set of QC materials should contain several analytes tested within the same lab. Finally, the vendor should provide a user support program, assisting customers with data analysis to track the performance of their assays.

With the growth of medical technology and the variety of current analytical methods, the days of a single lyophilized control, used throughout the chemistry laboratory, are long gone. Large medical laboratories are divided into separate analytical areas, for example, toxicology, immunology, and STAT labs, each of which provides a different subset of testing and needs specialized QC materials. Each of these materials would, in turn, be inappropriate for a smaller hospital or a POC laboratory.

Modern medical labs also require a variety of quality control materials because of the variety of samples they handle every day. A single assay, for example, may be performed routinely on s
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