Clinical Pathology: General Principles, Lab Management, Clinical Chemistry

63) The Levey-Jennings control chart for an assay performed in your laboratory is shown in the figure. The chart indicates which type of analytical problem for this assay?

• A Levey-Jennings control chart plots qualitycontrol (QC) results around their expected mean value.

• Acceptable limits for the deviation of the QC results from the expected value are determined by the laboratory.

• This is often achieved through the use of the Westgard rules, which are QC interpretive rules for statistical monitoring of assay accuracy and precision.

• Accuracy refers to how close an assay result value is with respect to the true value of the analyte.

• Accuracy can be assessed by measuring an analyte in reference material and comparing the result with the known certified concentration.

• Precision is the agreement between result values obtained by repeat measurements of a given quantity of the analyte.

Westgard JO: Basic QC Practices. 3rd ed. Madison, WI: Westgard QC; 2010.

Feinberg M: Validation of analytical methods based on accuracy profiles. J Chromatogr A 2007;1158:174-183.

 
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