The number of test samples required for adequate lot-to-lot validation protocols is high and may be prohibitively large, especially for low-volume or complex assays. Monitoring of the distributions of patient results has the potential to detect lot-to-lot inconsistencies relatively quickly.
Failure of Current Laboratory Protocols to Detect Lot-to-Lot Reagent Differences: Findings and Possible Solutions
Source: Clinical Chemistry
Art and Science of Laboratory Medicine
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