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OBJECTIVES "Average of normal" (AoN) or "moving average" is increasingly used as an adjunct quality control tool in laboratory practice. Little guidance exists on how to verify if an out-of-control situation in the AoN chart is due to a shift in analytical performance, or underlying patient characteristics. DESIGN AND METHODS Through simulation based on(More)
BACKGROUND Recently, the total prostate-specific antigen (PSA) assay used in a laboratory had a positive bias of 0.03 μg/L, which went undetected. Consequently, a number of post-prostatectomy patients with previously undetectable PSA concentrations (defined as <0.03 μg/L in that laboratory) were being reported as having detectable PSA, which suggested(More)
BACKGROUND Between-reagent lot verification is a routine laboratory exercise in which a set of samples is tested in parallel with an existing reagent lot and a candidate reagent lot (before the candidate lot is committed to test patient samples). The exercise aims to verify and maintain consistency in the analytical performance of a test. We examined the(More)
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