Long-term stability of laboratory tests and practical implications for quality management
Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality contro...
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De Gruyter ; 2013 |
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5 |
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Walter de Gruyter Online Zeitschriften |
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Enthalten in: Clinical chemistry and laboratory medicine - Berlin [u.a.] : De Gruyter, 1998, 51(2013), 6 vom: 22. Jan., Seite 1227-1231 |
| Übergeordnetes Werk: |
volume:51 ; year:2013 ; number:6 ; day:22 ; month:01 ; pages:1227-1231 ; extent:5 |
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| DOI / URN: |
10.1515/cclm-2012-0820 |
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NLEJ246695544 |
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| 520 | |a Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality control (IQC) data from two laboratories for tests to monitor chronic kidney and thyroid disease. Methods: We plotted moving means of the 50th percentiles of stratified patient data and of the daily IQC means. We evaluated observed instabilities based on goals inferred from the analytes’ biological variation and investigated their effect on classification of results against reference intervals. Results: Patient and IQC data generally matched well, except for analytes, for which other than analytical variation sources prevailed. Analytical instabilities were predominantly due to reagent/calibrator lot changes, however, for immunoassays also to within-lot instabilities, urging frequent recalibrations. The relevance of biased results on medical decisions ranged from negligible to very pronounced, indicating the need for assessment of analytical performance in relation to quality goals inferred from biological variation. Conclusions: Patient percentiles offer great potential to assess/monitor the medium- to long-term analytical stability of a test within certain constraints. Differences in analytical quality between assays can significantly affect medical outcome. | ||
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| 700 | 1 | |a Fiers, Tom |4 oth | |
| 700 | 1 | |a Stove, Veronique |4 oth | |
| 700 | 1 | |a Couck, Pedro |4 oth | |
| 700 | 1 | |a Anckaert, Ellen |4 oth | |
| 700 | 1 | |a Gorus, Frans |4 oth | |
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10.1515/cclm-2012-0820 doi artikel_Grundlieferung.pp (DE-627)NLEJ246695544 DE-627 ger DE-627 rakwb Long-term stability of laboratory tests and practical implications for quality management De Gruyter 2013 5 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality control (IQC) data from two laboratories for tests to monitor chronic kidney and thyroid disease. Methods: We plotted moving means of the 50th percentiles of stratified patient data and of the daily IQC means. We evaluated observed instabilities based on goals inferred from the analytes’ biological variation and investigated their effect on classification of results against reference intervals. Results: Patient and IQC data generally matched well, except for analytes, for which other than analytical variation sources prevailed. Analytical instabilities were predominantly due to reagent/calibrator lot changes, however, for immunoassays also to within-lot instabilities, urging frequent recalibrations. The relevance of biased results on medical decisions ranged from negligible to very pronounced, indicating the need for assessment of analytical performance in relation to quality goals inferred from biological variation. Conclusions: Patient percentiles offer great potential to assess/monitor the medium- to long-term analytical stability of a test within certain constraints. Differences in analytical quality between assays can significantly affect medical outcome. Walter de Gruyter Online Zeitschriften analytical performance IQC mean lot-to-lot variation moving mean patient 50th percentile patient median Van Houcke, Sofie K. oth Stepman, Hedwig C.M. oth Thienpont, Linda M. oth Fiers, Tom oth Stove, Veronique oth Couck, Pedro oth Anckaert, Ellen oth Gorus, Frans oth Enthalten in Clinical chemistry and laboratory medicine Berlin [u.a.] : De Gruyter, 1998 51(2013), 6 vom: 22. Jan., Seite 1227-1231 (DE-627)NLEJ248235222 (DE-600)1492732-9 1437-4331 nnns volume:51 year:2013 number:6 day:22 month:01 pages:1227-1231 extent:5 https://doi.org/10.1515/cclm-2012-0820 Deutschlandweit zugänglich GBV_USEFLAG_U ZDB-1-DGR GBV_NL_ARTICLE AR 51 2013 6 22 01 1227-1231 5 |
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10.1515/cclm-2012-0820 doi artikel_Grundlieferung.pp (DE-627)NLEJ246695544 DE-627 ger DE-627 rakwb Long-term stability of laboratory tests and practical implications for quality management De Gruyter 2013 5 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality control (IQC) data from two laboratories for tests to monitor chronic kidney and thyroid disease. Methods: We plotted moving means of the 50th percentiles of stratified patient data and of the daily IQC means. We evaluated observed instabilities based on goals inferred from the analytes’ biological variation and investigated their effect on classification of results against reference intervals. Results: Patient and IQC data generally matched well, except for analytes, for which other than analytical variation sources prevailed. Analytical instabilities were predominantly due to reagent/calibrator lot changes, however, for immunoassays also to within-lot instabilities, urging frequent recalibrations. The relevance of biased results on medical decisions ranged from negligible to very pronounced, indicating the need for assessment of analytical performance in relation to quality goals inferred from biological variation. Conclusions: Patient percentiles offer great potential to assess/monitor the medium- to long-term analytical stability of a test within certain constraints. Differences in analytical quality between assays can significantly affect medical outcome. Walter de Gruyter Online Zeitschriften analytical performance IQC mean lot-to-lot variation moving mean patient 50th percentile patient median Van Houcke, Sofie K. oth Stepman, Hedwig C.M. oth Thienpont, Linda M. oth Fiers, Tom oth Stove, Veronique oth Couck, Pedro oth Anckaert, Ellen oth Gorus, Frans oth Enthalten in Clinical chemistry and laboratory medicine Berlin [u.a.] : De Gruyter, 1998 51(2013), 6 vom: 22. Jan., Seite 1227-1231 (DE-627)NLEJ248235222 (DE-600)1492732-9 1437-4331 nnns volume:51 year:2013 number:6 day:22 month:01 pages:1227-1231 extent:5 https://doi.org/10.1515/cclm-2012-0820 Deutschlandweit zugänglich GBV_USEFLAG_U ZDB-1-DGR GBV_NL_ARTICLE AR 51 2013 6 22 01 1227-1231 5 |
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10.1515/cclm-2012-0820 doi artikel_Grundlieferung.pp (DE-627)NLEJ246695544 DE-627 ger DE-627 rakwb Long-term stability of laboratory tests and practical implications for quality management De Gruyter 2013 5 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality control (IQC) data from two laboratories for tests to monitor chronic kidney and thyroid disease. Methods: We plotted moving means of the 50th percentiles of stratified patient data and of the daily IQC means. We evaluated observed instabilities based on goals inferred from the analytes’ biological variation and investigated their effect on classification of results against reference intervals. Results: Patient and IQC data generally matched well, except for analytes, for which other than analytical variation sources prevailed. Analytical instabilities were predominantly due to reagent/calibrator lot changes, however, for immunoassays also to within-lot instabilities, urging frequent recalibrations. The relevance of biased results on medical decisions ranged from negligible to very pronounced, indicating the need for assessment of analytical performance in relation to quality goals inferred from biological variation. Conclusions: Patient percentiles offer great potential to assess/monitor the medium- to long-term analytical stability of a test within certain constraints. Differences in analytical quality between assays can significantly affect medical outcome. Walter de Gruyter Online Zeitschriften analytical performance IQC mean lot-to-lot variation moving mean patient 50th percentile patient median Van Houcke, Sofie K. oth Stepman, Hedwig C.M. oth Thienpont, Linda M. oth Fiers, Tom oth Stove, Veronique oth Couck, Pedro oth Anckaert, Ellen oth Gorus, Frans oth Enthalten in Clinical chemistry and laboratory medicine Berlin [u.a.] : De Gruyter, 1998 51(2013), 6 vom: 22. Jan., Seite 1227-1231 (DE-627)NLEJ248235222 (DE-600)1492732-9 1437-4331 nnns volume:51 year:2013 number:6 day:22 month:01 pages:1227-1231 extent:5 https://doi.org/10.1515/cclm-2012-0820 Deutschlandweit zugänglich GBV_USEFLAG_U ZDB-1-DGR GBV_NL_ARTICLE AR 51 2013 6 22 01 1227-1231 5 |
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10.1515/cclm-2012-0820 doi artikel_Grundlieferung.pp (DE-627)NLEJ246695544 DE-627 ger DE-627 rakwb Long-term stability of laboratory tests and practical implications for quality management De Gruyter 2013 5 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality control (IQC) data from two laboratories for tests to monitor chronic kidney and thyroid disease. Methods: We plotted moving means of the 50th percentiles of stratified patient data and of the daily IQC means. We evaluated observed instabilities based on goals inferred from the analytes’ biological variation and investigated their effect on classification of results against reference intervals. Results: Patient and IQC data generally matched well, except for analytes, for which other than analytical variation sources prevailed. Analytical instabilities were predominantly due to reagent/calibrator lot changes, however, for immunoassays also to within-lot instabilities, urging frequent recalibrations. The relevance of biased results on medical decisions ranged from negligible to very pronounced, indicating the need for assessment of analytical performance in relation to quality goals inferred from biological variation. Conclusions: Patient percentiles offer great potential to assess/monitor the medium- to long-term analytical stability of a test within certain constraints. Differences in analytical quality between assays can significantly affect medical outcome. Walter de Gruyter Online Zeitschriften analytical performance IQC mean lot-to-lot variation moving mean patient 50th percentile patient median Van Houcke, Sofie K. oth Stepman, Hedwig C.M. oth Thienpont, Linda M. oth Fiers, Tom oth Stove, Veronique oth Couck, Pedro oth Anckaert, Ellen oth Gorus, Frans oth Enthalten in Clinical chemistry and laboratory medicine Berlin [u.a.] : De Gruyter, 1998 51(2013), 6 vom: 22. Jan., Seite 1227-1231 (DE-627)NLEJ248235222 (DE-600)1492732-9 1437-4331 nnns volume:51 year:2013 number:6 day:22 month:01 pages:1227-1231 extent:5 https://doi.org/10.1515/cclm-2012-0820 Deutschlandweit zugänglich GBV_USEFLAG_U ZDB-1-DGR GBV_NL_ARTICLE AR 51 2013 6 22 01 1227-1231 5 |
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10.1515/cclm-2012-0820 doi artikel_Grundlieferung.pp (DE-627)NLEJ246695544 DE-627 ger DE-627 rakwb Long-term stability of laboratory tests and practical implications for quality management De Gruyter 2013 5 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality control (IQC) data from two laboratories for tests to monitor chronic kidney and thyroid disease. Methods: We plotted moving means of the 50th percentiles of stratified patient data and of the daily IQC means. We evaluated observed instabilities based on goals inferred from the analytes’ biological variation and investigated their effect on classification of results against reference intervals. Results: Patient and IQC data generally matched well, except for analytes, for which other than analytical variation sources prevailed. Analytical instabilities were predominantly due to reagent/calibrator lot changes, however, for immunoassays also to within-lot instabilities, urging frequent recalibrations. The relevance of biased results on medical decisions ranged from negligible to very pronounced, indicating the need for assessment of analytical performance in relation to quality goals inferred from biological variation. Conclusions: Patient percentiles offer great potential to assess/monitor the medium- to long-term analytical stability of a test within certain constraints. Differences in analytical quality between assays can significantly affect medical outcome. Walter de Gruyter Online Zeitschriften analytical performance IQC mean lot-to-lot variation moving mean patient 50th percentile patient median Van Houcke, Sofie K. oth Stepman, Hedwig C.M. oth Thienpont, Linda M. oth Fiers, Tom oth Stove, Veronique oth Couck, Pedro oth Anckaert, Ellen oth Gorus, Frans oth Enthalten in Clinical chemistry and laboratory medicine Berlin [u.a.] : De Gruyter, 1998 51(2013), 6 vom: 22. Jan., Seite 1227-1231 (DE-627)NLEJ248235222 (DE-600)1492732-9 1437-4331 nnns volume:51 year:2013 number:6 day:22 month:01 pages:1227-1231 extent:5 https://doi.org/10.1515/cclm-2012-0820 Deutschlandweit zugänglich GBV_USEFLAG_U ZDB-1-DGR GBV_NL_ARTICLE AR 51 2013 6 22 01 1227-1231 5 |
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Long-term stability of laboratory tests and practical implications for quality management |
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Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality control (IQC) data from two laboratories for tests to monitor chronic kidney and thyroid disease. Methods: We plotted moving means of the 50th percentiles of stratified patient data and of the daily IQC means. We evaluated observed instabilities based on goals inferred from the analytes’ biological variation and investigated their effect on classification of results against reference intervals. Results: Patient and IQC data generally matched well, except for analytes, for which other than analytical variation sources prevailed. Analytical instabilities were predominantly due to reagent/calibrator lot changes, however, for immunoassays also to within-lot instabilities, urging frequent recalibrations. The relevance of biased results on medical decisions ranged from negligible to very pronounced, indicating the need for assessment of analytical performance in relation to quality goals inferred from biological variation. Conclusions: Patient percentiles offer great potential to assess/monitor the medium- to long-term analytical stability of a test within certain constraints. Differences in analytical quality between assays can significantly affect medical outcome. |
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Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality control (IQC) data from two laboratories for tests to monitor chronic kidney and thyroid disease. Methods: We plotted moving means of the 50th percentiles of stratified patient data and of the daily IQC means. We evaluated observed instabilities based on goals inferred from the analytes’ biological variation and investigated their effect on classification of results against reference intervals. Results: Patient and IQC data generally matched well, except for analytes, for which other than analytical variation sources prevailed. Analytical instabilities were predominantly due to reagent/calibrator lot changes, however, for immunoassays also to within-lot instabilities, urging frequent recalibrations. The relevance of biased results on medical decisions ranged from negligible to very pronounced, indicating the need for assessment of analytical performance in relation to quality goals inferred from biological variation. Conclusions: Patient percentiles offer great potential to assess/monitor the medium- to long-term analytical stability of a test within certain constraints. Differences in analytical quality between assays can significantly affect medical outcome. |
| abstract_unstemmed |
Background: Long-term stability of analytical performance is required for adequate patient management. We investigated the use of patient data to document test stability, and the relevance of observed instabilities on a surrogate medical outcome. We used multiyear patient and internal quality control (IQC) data from two laboratories for tests to monitor chronic kidney and thyroid disease. Methods: We plotted moving means of the 50th percentiles of stratified patient data and of the daily IQC means. We evaluated observed instabilities based on goals inferred from the analytes’ biological variation and investigated their effect on classification of results against reference intervals. Results: Patient and IQC data generally matched well, except for analytes, for which other than analytical variation sources prevailed. Analytical instabilities were predominantly due to reagent/calibrator lot changes, however, for immunoassays also to within-lot instabilities, urging frequent recalibrations. The relevance of biased results on medical decisions ranged from negligible to very pronounced, indicating the need for assessment of analytical performance in relation to quality goals inferred from biological variation. Conclusions: Patient percentiles offer great potential to assess/monitor the medium- to long-term analytical stability of a test within certain constraints. Differences in analytical quality between assays can significantly affect medical outcome. |
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| title_short |
Long-term stability of laboratory tests and practical implications for quality management |
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https://doi.org/10.1515/cclm-2012-0820 |
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| author2 |
Van Houcke, Sofie K. Stepman, Hedwig C.M. Thienpont, Linda M. Fiers, Tom Stove, Veronique Couck, Pedro Anckaert, Ellen Gorus, Frans |
| author2Str |
Van Houcke, Sofie K. Stepman, Hedwig C.M. Thienpont, Linda M. Fiers, Tom Stove, Veronique Couck, Pedro Anckaert, Ellen Gorus, Frans |
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NLEJ248235222 |
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10.1515/cclm-2012-0820 |
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2024-07-06T09:05:35.369Z |
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