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Assessment of patient based real‐time quality control on comparative assays for common clinical analytes
BACKGROUND: It is critical for laboratories to conduct multianalyzer comparisons as a part of daily routine work to strengthen the quality management of test systems. Here, we explored the application of patient‐based real‐time quality controls (PBRTQCs) on comparative assays to monitor the consiste...
Autores principales: | , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2022
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9459303/ https://www.ncbi.nlm.nih.gov/pubmed/35949026 http://dx.doi.org/10.1002/jcla.24651 |
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author | Lu, Yide Yang, Fan Wen, Dongmei Shi, Kaifeng Gu, Zhichao Lu, Qiuya Wang, Xuefeng Dong, Danfeng |
author_facet | Lu, Yide Yang, Fan Wen, Dongmei Shi, Kaifeng Gu, Zhichao Lu, Qiuya Wang, Xuefeng Dong, Danfeng |
author_sort | Lu, Yide |
collection | PubMed |
description | BACKGROUND: It is critical for laboratories to conduct multianalyzer comparisons as a part of daily routine work to strengthen the quality management of test systems. Here, we explored the application of patient‐based real‐time quality controls (PBRTQCs) on comparative assays to monitor the consistency among clinical laboratories. METHODS: The present study included 11 commonly tested analytes that were detected using three analyzers. PBRTQC procedures were set up with exponentially weighted moving average (EWMA) algorithms and evaluated using the AI‐MA artificial intelligence platform. Comparative assays were carried out on serum samples, and patient data were collected. Patients were divided into total patient (TP), inpatient (IP), and outpatient (OP) groups. RESULTS: Optimal PBRTQC protocols were evaluated and selected with appropriate truncation limits and smoothing factors. Generally, similar comparative assay performance was achieved using both the EWMA and median methods. Good consistency between the results from patients' data and serum samples was obtained, and unacceptable bias was detected for alkaline phosphatase (ALP) and gamma‐glutamyl transferase (GGT) when using analyzer C. Categorizing patients' data and applying specific groups for comparative assays could significantly improve the performance of PBRTQCs. When monitoring the inter‐ and intraanalyzer stability on a daily basis, EWMA was superior in detecting very small quality‐related changes with lower false‐positive alarms. CONCLUSIONS: We found that PBRTQCs have the potential to efficiently assess multianalyzer comparability. Laboratories should be aware of population variations concerning both analytes and analyzers to build more suitable PBRTQC protocols. |
format | Online Article Text |
id | pubmed-9459303 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-94593032022-09-12 Assessment of patient based real‐time quality control on comparative assays for common clinical analytes Lu, Yide Yang, Fan Wen, Dongmei Shi, Kaifeng Gu, Zhichao Lu, Qiuya Wang, Xuefeng Dong, Danfeng J Clin Lab Anal Research Articles BACKGROUND: It is critical for laboratories to conduct multianalyzer comparisons as a part of daily routine work to strengthen the quality management of test systems. Here, we explored the application of patient‐based real‐time quality controls (PBRTQCs) on comparative assays to monitor the consistency among clinical laboratories. METHODS: The present study included 11 commonly tested analytes that were detected using three analyzers. PBRTQC procedures were set up with exponentially weighted moving average (EWMA) algorithms and evaluated using the AI‐MA artificial intelligence platform. Comparative assays were carried out on serum samples, and patient data were collected. Patients were divided into total patient (TP), inpatient (IP), and outpatient (OP) groups. RESULTS: Optimal PBRTQC protocols were evaluated and selected with appropriate truncation limits and smoothing factors. Generally, similar comparative assay performance was achieved using both the EWMA and median methods. Good consistency between the results from patients' data and serum samples was obtained, and unacceptable bias was detected for alkaline phosphatase (ALP) and gamma‐glutamyl transferase (GGT) when using analyzer C. Categorizing patients' data and applying specific groups for comparative assays could significantly improve the performance of PBRTQCs. When monitoring the inter‐ and intraanalyzer stability on a daily basis, EWMA was superior in detecting very small quality‐related changes with lower false‐positive alarms. CONCLUSIONS: We found that PBRTQCs have the potential to efficiently assess multianalyzer comparability. Laboratories should be aware of population variations concerning both analytes and analyzers to build more suitable PBRTQC protocols. John Wiley and Sons Inc. 2022-08-10 /pmc/articles/PMC9459303/ /pubmed/35949026 http://dx.doi.org/10.1002/jcla.24651 Text en © 2022 The Authors. Journal of Clinical Laboratory Analysis published by Wiley Periodicals LLC. https://creativecommons.org/licenses/by-nc-nd/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ (https://creativecommons.org/licenses/by-nc-nd/4.0/) License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made. |
spellingShingle | Research Articles Lu, Yide Yang, Fan Wen, Dongmei Shi, Kaifeng Gu, Zhichao Lu, Qiuya Wang, Xuefeng Dong, Danfeng Assessment of patient based real‐time quality control on comparative assays for common clinical analytes |
title | Assessment of patient based real‐time quality control on comparative assays for common clinical analytes |
title_full | Assessment of patient based real‐time quality control on comparative assays for common clinical analytes |
title_fullStr | Assessment of patient based real‐time quality control on comparative assays for common clinical analytes |
title_full_unstemmed | Assessment of patient based real‐time quality control on comparative assays for common clinical analytes |
title_short | Assessment of patient based real‐time quality control on comparative assays for common clinical analytes |
title_sort | assessment of patient based real‐time quality control on comparative assays for common clinical analytes |
topic | Research Articles |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9459303/ https://www.ncbi.nlm.nih.gov/pubmed/35949026 http://dx.doi.org/10.1002/jcla.24651 |
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