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A primary goal in clinical laboratories is to produce accurate test results. In fact, after labs arrive at the sweet spot of desirable exactitude, they struggle to keep conditions as stable as possible. Much of the everyday job in the lab consists of managing change, expected or not. Among the most challenging changes are those affecting materials: samples, calibrators, internal and external controls, and the reagents used to perform the tests themselves.

Many of these changes can be detected and evaluated by the lab’s analytical quality control (QC) program, but detecting differences in test results caused by changes of test reagent lots constitutes a greater challenge because internal lab QC frequently fails to appropriately reflect the changes in patient sample results obtained using different manufacturer lots of the reagents used.

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QC practices that prevent inaccurate results from reagent lot variances

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