Abstract
The variability between calibrations can be larger than the within calibration variation for some measurement procedures, that is a large CVbetween:CVwithin ratio. In this study, we examined the false rejection rate and probability of bias detection of quality control (QC) rules at varying calibration CVbetween:CVwithin ratios.
Historical QC data for six representative routine clinical chemistry serum measurement procedures (calcium, creatinine, aspartate aminotransferase, thyrotrophin, prostate specific antigen and gentamicin) were extracted to derive the CVbetween:CVwithin ratios using analysis of variance. Additionally, the false rejection rate and probability of bias detection of three ‘Westgard’ QC rules (2:2S, 4:1S, 10X) at varying CVbetween:CVwithin ratios (0.1–10), magnitudes of bias, and QC events per calibration (5–80) were examined through simulation modelling.
The CVbetween:CVwithin ratios for the six routine measurement procedures ranged from 1.1 to 34.5. With ratios >3, false rejection rates were generally above 10%. Similarly for QC rules involving a greater number of consecutive results, false rejection rates increased with increasing ratios, while all rules achieved maximum bias detection.
Laboratories should avoid the 2:2S, 4:1S and 10X QC rules when calibration CVbetween:CVwithin ratios are elevated, particularly for those measurement procedures with a higher number of QC events per calibration.
Original language | English |
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Pages (from-to) | 525-530 |
Number of pages | 6 |
Journal | Pathology |
Volume | 55 |
Issue number | 4 |
Early online date | 16 Feb 2023 |
DOIs | |
Publication status | Published - Jun 2023 |
Keywords
- Calibration
- laboratory management
- precision
- quality control