Application of the sigma metrics to evaluate the analytical performance of cystatin C and design a quality control strategy
| Autor: | Wenjun Zhu, Changxin Zhao, Guangrong Bian, Qian Liu, Fumeng Yang, Wei Liang |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Quality Control
030213 general clinical medicine biology Laboratory management Computer science media_common.quotation_subject Clinical Biochemistry Control (management) General Medicine Sigma Metrics Reliability engineering 03 medical and health sciences 0302 clinical medicine Cystatin C Reference Values 030220 oncology & carcinogenesis Biological variation biology.protein Humans Quality (business) Laboratories media_common Total Quality Management |
| Zdroj: | Annals of clinical biochemistry. 58(3) |
| ISSN: | 1758-1001 |
| Popis: | Background Sigma metrics are commonly used to evaluate laboratory management. In this study, we aimed to evaluate the analytical performance of cystatin C using sigma metrics and to develop an individualized quality control scheme for cystatin C concentrations. Methods Bias was calculated based on the samples used for the external quality assessment. The coefficient of variation was calculated using six months of internal quality control measurements at two levels, and desirable specification derived from biological variation was used as the quality goal. The sigma value for cystatin C was calculated using the above data. The internal quality control scheme and improvement measures were formulated according to the Westgard sigma standards for batch size and quality goal index. Results The sigma values for cystatin C, for quality control levels 1 and 2, were 3.04 and 4.95, respectively. The 13s/22s/R4s/41s/6x multirules ( n = 6, R = 1), with a batch size of 45 patient samples, were selected as the internal quality control schemes for cystatin C. With different concentrations of cystatin C, the power function graph showed a probability for error detection of 94% and 100% and a probability for false rejection of 4% and 2%, respectively. According to the quality goal index of cystatin C, its precision needs to be improved. Conclusions With a ‘desirable’ biological variation of 6.50%, the Westgard rule 13s/22s/R4s/41s/6x ( n = 6, R = 1, batch size of 45) with high efficacy for determining the detection error is recommended for individualized quality control schemes of cystatin C. |
| Databáze: | OpenAIRE |
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