These included the AAPS Flow Cytometry Action Program Committee, International Council for Standardization in Haematology and the International Clinical Cytometry Society. In order to help ensure quality of flow cytometry assay performance across pre-clinical and clinical applications, several organizations have published recommendations for the standardization of flow cytometry instrumentation and method validation for clinical applications. This confusion stems from several aspects including the fact that although the terms are not interchangeable, they can mean different things within different applications. Westgard Multirule QC Quantitative QC-Module 7Īctivity Using the Westgard Multirule System, describe the control values for each day in the following slide.When it comes to assay development for pre-clinical and clinical applications, there may be confusion about the need to either qualify or validate an assay’s performance. Westgard – 10X Rule requires control data from previous runs ten consecutive QC results for one level of control are on one side of the mean, or both levels of control have five consecutive results that are on the same side of the mean Quantitative QC-Module 7 Westgard – 41S Rule requires control data from previous runs four consecutive QC results for one level of control are outside ☑SD, or both levels of control have consecutive results that are outside ☑SD. Random error has occurred, test run must be rejected. The range between the two results will therefore exceed 4 SD. Westgard – R4S Rule One control exceeds the mean by –2SD, and the other control exceeds the mean by +2SD. Requires corrective action Quantitative QC-Module 7 Quantitative QC - Module 8 Westgard – 22S Rule Two consecutive control values for the same level fall outside of ☒SD in the same direction, or Both controls in the same run exceed ☒SD.
Westgard – 12S Rule WARNING RULE – not cause for rejecting a run One of two control results falls outside ☒SD Alerts technologist to possible problems Must then evaluate the 13S rule Quantitative QC-Module 7 Westgard Multirule System Titles 12S rule 13S rule 22S rule R4S rule 41S rule 10X rule Used when 2 levels of control material are analyzed per run. Westgard based on statistical concepts a combination of decision criteria or rules to assess if a system is in control use when at least 2 levels of control are run with the examination run cannot use with only one control Dr.
Westgard Multirule System a “multi-rule” system developed by Dr.
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