APS calculator: A data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data
Само за регистроване кориснике
2023
Аутори
Çubukçu, Hikmet CanVanstapel, Florent
Thelen, Marc
Van Schrojenstein Lantman, Marith
Bernabeu-Andreu, Francisco A
Meško Brguljan, Pika
Milinković, Neda
Linko, Solveig
Panteghini, Mauro
Boursier, Guilaine
Чланак у часопису (Објављена верзија)
Метаподаци
Приказ свих података о документуАпстракт
According to ISO 15189:2022, analytical performance specifications (APS) should relate to intended clinical use and impact on patient care. Therefore, we aimed to develop a web application for laboratory professionals to calculate APS based on a simulation of the impact of measurement uncertainty (MU) on the outcome using the chosen decision limits, agreement thresholds, and data of the population of interest. We developed the "APS Calculator"allowing users to upload and select data of concern, specify decision limits and agreement thresholds, and conduct simulations to determine APS for MU. The simulation involved categorizing original measurand concentrations, generating measured (simulated) results by introducing different degrees of MU, and recategorizing measured concentrations based on clinical decision limits and acceptable clinical misclassification rates. The agreements between original and simulated result categories were assessed, and values that met or exceeded user-specifi...ed agreement thresholds that set goals for the between-category agreement were considered acceptable. The application generates contour plots of agreement rates and corresponding MU values. We tested the application using National Health and Nutrition Examination Survey data, with decision limits from relevant guidelines. We determined APS for MU of six measurands (blood total hemoglobin, plasma fasting glucose, serum total and high-density lipoprotein cholesterol, triglycerides, and total folate) to demonstrate the potential of the application to generate APS. The developed data-driven web application offers a flexible tool for laboratory professionals to calculate APS for MU using their chosen decision limits and agreement thresholds, and the data of the population of interest.
Кључне речи:
analytical performance specifications / data / decision limits / ISO 15189 / measurement uncertainty / outcomeИзвор:
Clinical Chemistry and Laboratory Medicine, 2023Издавач:
- Walter de Gruyter GmbH
DOI: 10.1515/cclm-2023-0740
ISSN: 1434-6621
PubMed: 37978287
WoS: 001106524300001
Scopus: 2-s2.0-85178309336
Институција/група
PharmacyTY - JOUR AU - Çubukçu, Hikmet Can AU - Vanstapel, Florent AU - Thelen, Marc AU - Van Schrojenstein Lantman, Marith AU - Bernabeu-Andreu, Francisco A AU - Meško Brguljan, Pika AU - Milinković, Neda AU - Linko, Solveig AU - Panteghini, Mauro AU - Boursier, Guilaine PY - 2023 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/5345 AB - According to ISO 15189:2022, analytical performance specifications (APS) should relate to intended clinical use and impact on patient care. Therefore, we aimed to develop a web application for laboratory professionals to calculate APS based on a simulation of the impact of measurement uncertainty (MU) on the outcome using the chosen decision limits, agreement thresholds, and data of the population of interest. We developed the "APS Calculator"allowing users to upload and select data of concern, specify decision limits and agreement thresholds, and conduct simulations to determine APS for MU. The simulation involved categorizing original measurand concentrations, generating measured (simulated) results by introducing different degrees of MU, and recategorizing measured concentrations based on clinical decision limits and acceptable clinical misclassification rates. The agreements between original and simulated result categories were assessed, and values that met or exceeded user-specified agreement thresholds that set goals for the between-category agreement were considered acceptable. The application generates contour plots of agreement rates and corresponding MU values. We tested the application using National Health and Nutrition Examination Survey data, with decision limits from relevant guidelines. We determined APS for MU of six measurands (blood total hemoglobin, plasma fasting glucose, serum total and high-density lipoprotein cholesterol, triglycerides, and total folate) to demonstrate the potential of the application to generate APS. The developed data-driven web application offers a flexible tool for laboratory professionals to calculate APS for MU using their chosen decision limits and agreement thresholds, and the data of the population of interest. PB - Walter de Gruyter GmbH T2 - Clinical Chemistry and Laboratory Medicine T1 - APS calculator: A data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data DO - 10.1515/cclm-2023-0740 ER -
@article{ author = "Çubukçu, Hikmet Can and Vanstapel, Florent and Thelen, Marc and Van Schrojenstein Lantman, Marith and Bernabeu-Andreu, Francisco A and Meško Brguljan, Pika and Milinković, Neda and Linko, Solveig and Panteghini, Mauro and Boursier, Guilaine", year = "2023", abstract = "According to ISO 15189:2022, analytical performance specifications (APS) should relate to intended clinical use and impact on patient care. Therefore, we aimed to develop a web application for laboratory professionals to calculate APS based on a simulation of the impact of measurement uncertainty (MU) on the outcome using the chosen decision limits, agreement thresholds, and data of the population of interest. We developed the "APS Calculator"allowing users to upload and select data of concern, specify decision limits and agreement thresholds, and conduct simulations to determine APS for MU. The simulation involved categorizing original measurand concentrations, generating measured (simulated) results by introducing different degrees of MU, and recategorizing measured concentrations based on clinical decision limits and acceptable clinical misclassification rates. The agreements between original and simulated result categories were assessed, and values that met or exceeded user-specified agreement thresholds that set goals for the between-category agreement were considered acceptable. The application generates contour plots of agreement rates and corresponding MU values. We tested the application using National Health and Nutrition Examination Survey data, with decision limits from relevant guidelines. We determined APS for MU of six measurands (blood total hemoglobin, plasma fasting glucose, serum total and high-density lipoprotein cholesterol, triglycerides, and total folate) to demonstrate the potential of the application to generate APS. The developed data-driven web application offers a flexible tool for laboratory professionals to calculate APS for MU using their chosen decision limits and agreement thresholds, and the data of the population of interest.", publisher = "Walter de Gruyter GmbH", journal = "Clinical Chemistry and Laboratory Medicine", title = "APS calculator: A data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data", doi = "10.1515/cclm-2023-0740" }
Çubukçu, H. C., Vanstapel, F., Thelen, M., Van Schrojenstein Lantman, M., Bernabeu-Andreu, F. A., Meško Brguljan, P., Milinković, N., Linko, S., Panteghini, M.,& Boursier, G.. (2023). APS calculator: A data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data. in Clinical Chemistry and Laboratory Medicine Walter de Gruyter GmbH.. https://doi.org/10.1515/cclm-2023-0740
Çubukçu HC, Vanstapel F, Thelen M, Van Schrojenstein Lantman M, Bernabeu-Andreu FA, Meško Brguljan P, Milinković N, Linko S, Panteghini M, Boursier G. APS calculator: A data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data. in Clinical Chemistry and Laboratory Medicine. 2023;. doi:10.1515/cclm-2023-0740 .
Çubukçu, Hikmet Can, Vanstapel, Florent, Thelen, Marc, Van Schrojenstein Lantman, Marith, Bernabeu-Andreu, Francisco A, Meško Brguljan, Pika, Milinković, Neda, Linko, Solveig, Panteghini, Mauro, Boursier, Guilaine, "APS calculator: A data-driven tool for setting outcome-based analytical performance specifications for measurement uncertainty using specific clinical requirements and population data" in Clinical Chemistry and Laboratory Medicine (2023), https://doi.org/10.1515/cclm-2023-0740 . .