TY  - 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 . .

TY  - JOUR
AU  - Van Schrojenstein Lantman, Marith
AU  - Çubukçu, Hikmet Can
AU  - Boursier, Guilaine
AU  - Panteghini, Mauro
AU  - Bernabeu-Andreu, Francisco
AU  - Milinković, Neda
AU  - Mesko Brguljan, Pika
AU  - Linko, Solveig
AU  - Brugnoni, Duilio
AU  - O'Kelly, Ruth
AU  - Kroupis, Christos
AU  - Lohmander, Maria
AU  - Šprongl, Luděk
AU  - Vanstapel, Florent
AU  - Thelen, Marc
PY  - 2022
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/4072
AB  - Clinicians trust medical laboratories to provide reliable results on which they rely for clinical decisions. Lab- oratories fulfil their responsibility for accurate and consistent results by utilizing an arsenal of approaches, ranging from validation and verification experiments to daily quality control procedures. All these procedures verify, on different moments, that the results of a certain examination procedure have analytical performance characteristics (APC) that meet analytical performance specifications (APS) set for a particular intended use. The APC can in part be determined by esti- mating the measurement uncertainty component under con- ditions of within-laboratory precision (uRw), which comprises all components influencing the measurement uncertainty of random sources. To maintain the adequacy of their mea- surement procedures, laboratories need to distinguish aspects that are manageable vs. those that are not. One of the aspects that may influence uRw is the momentary significant bias caused by shifts in reagent and/or calibrator lots, which, when accepted or unnoticed, become a factor of the APC. In this paper, we postulate a model for allocating a part of allowable uRw to between-reagent lot variation, based on the need for long-term consistency of the measurement variability for that specific measurand. The allocation manages the ratio between short-term and long-term variation and indicates laboratories when to reject or correct certain variations due to reagent lots.
PB  - De Gruyter Open Ltd
T2  - Clinical Chemistry and Laboratory Medicine
T1  - An approach for determining allowable between reagent lot variation
VL  - 60
IS  - 5
SP  - 681
EP  - 688
DO  - 10.1515/cclm-2022-0083
ER  - 

@article{
author = "Van Schrojenstein Lantman, Marith and Çubukçu, Hikmet Can and Boursier, Guilaine and Panteghini, Mauro and Bernabeu-Andreu, Francisco and Milinković, Neda and Mesko Brguljan, Pika and Linko, Solveig and Brugnoni, Duilio and O'Kelly, Ruth and Kroupis, Christos and Lohmander, Maria and Šprongl, Luděk and Vanstapel, Florent and Thelen, Marc",
year = "2022",
abstract = "Clinicians trust medical laboratories to provide reliable results on which they rely for clinical decisions. Lab- oratories fulfil their responsibility for accurate and consistent results by utilizing an arsenal of approaches, ranging from validation and verification experiments to daily quality control procedures. All these procedures verify, on different moments, that the results of a certain examination procedure have analytical performance characteristics (APC) that meet analytical performance specifications (APS) set for a particular intended use. The APC can in part be determined by esti- mating the measurement uncertainty component under con- ditions of within-laboratory precision (uRw), which comprises all components influencing the measurement uncertainty of random sources. To maintain the adequacy of their mea- surement procedures, laboratories need to distinguish aspects that are manageable vs. those that are not. One of the aspects that may influence uRw is the momentary significant bias caused by shifts in reagent and/or calibrator lots, which, when accepted or unnoticed, become a factor of the APC. In this paper, we postulate a model for allocating a part of allowable uRw to between-reagent lot variation, based on the need for long-term consistency of the measurement variability for that specific measurand. The allocation manages the ratio between short-term and long-term variation and indicates laboratories when to reject or correct certain variations due to reagent lots.",
publisher = "De Gruyter Open Ltd",
journal = "Clinical Chemistry and Laboratory Medicine",
title = "An approach for determining allowable between reagent lot variation",
volume = "60",
number = "5",
pages = "681-688",
doi = "10.1515/cclm-2022-0083"
}

Van Schrojenstein Lantman, M., Çubukçu, H. C., Boursier, G., Panteghini, M., Bernabeu-Andreu, F., Milinković, N., Mesko Brguljan, P., Linko, S., Brugnoni, D., O'Kelly, R., Kroupis, C., Lohmander, M., Šprongl, L., Vanstapel, F.,& Thelen, M.. (2022). An approach for determining allowable between reagent lot variation. in Clinical Chemistry and Laboratory Medicine
De Gruyter Open Ltd., 60(5), 681-688.
https://doi.org/10.1515/cclm-2022-0083

Van Schrojenstein Lantman M, Çubukçu HC, Boursier G, Panteghini M, Bernabeu-Andreu F, Milinković N, Mesko Brguljan P, Linko S, Brugnoni D, O'Kelly R, Kroupis C, Lohmander M, Šprongl L, Vanstapel F, Thelen M. An approach for determining allowable between reagent lot variation. in Clinical Chemistry and Laboratory Medicine. 2022;60(5):681-688.
doi:10.1515/cclm-2022-0083 .

Van Schrojenstein Lantman, Marith, Çubukçu, Hikmet Can, Boursier, Guilaine, Panteghini, Mauro, Bernabeu-Andreu, Francisco, Milinković, Neda, Mesko Brguljan, Pika, Linko, Solveig, Brugnoni, Duilio, O'Kelly, Ruth, Kroupis, Christos, Lohmander, Maria, Šprongl, Luděk, Vanstapel, Florent, Thelen, Marc, "An approach for determining allowable between reagent lot variation" in Clinical Chemistry and Laboratory Medicine, 60, no. 5 (2022):681-688,
https://doi.org/10.1515/cclm-2022-0083 . .

TY  - JOUR
AU  - Çubukçu, Hikmet Can
AU  - Vanstapel, Florent
AU  - Thelen, Marc
AU  - Bernabeu-Andreu, Francisco A.
AU  - Van Schrojenstein Lantman, Marith
AU  - Brugnoni, Duilio
AU  - Mesko Brguljan, Pika
AU  - Milinković, Neda
AU  - Linko, Solveig
AU  - Vaubourdolle, Michel
AU  - O'Kelly, Ruth
AU  - Kroupis, Christos
AU  - Lohmander, Maria
AU  - Šprongl, Luděk
AU  - Panteghini, Mauro
AU  - Boursier, Guilaine
PY  - 2021
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/4077
AB  - The ISO 15189:2012 standard section 5.9.1 requires laboratories to review results before release, considering quality control, previous results, and clinical information, if any, and to issue documented procedures about it. While laboratory result reporting is generally regarded as part of the post-analytical phase, the result release process requires a general view of the total examination process. Reviewing test results may follow with troubleshooting and test repetition, including reanalyzing an individual sample or resampling. A systematic understanding of the result release may help laboratory professionals carry out appropriate test repetition and ensure the plausibility of laboratory results. In this paper, we addressed the crucial steps in the result release process, including evaluation of sample quality, critical result notification, result reporting, and recommendations for the management of the result release, considering quality control alerts, instrument flags, warning messages, and interference indexes. Error detection tools and plausibility checks mentioned in the present paper can support the daily practice of results release.
PB  - Elsevier
T2  - Clinica Chimica Acta
T1  - Improving the laboratory result release process in the light of ISO 15189:2012 standard
VL  - 522
SP  - 167
EP  - 173
DO  - 10.1016/j.cca.2021.08.013
ER  - 

@article{
author = "Çubukçu, Hikmet Can and Vanstapel, Florent and Thelen, Marc and Bernabeu-Andreu, Francisco A. and Van Schrojenstein Lantman, Marith and Brugnoni, Duilio and Mesko Brguljan, Pika and Milinković, Neda and Linko, Solveig and Vaubourdolle, Michel and O'Kelly, Ruth and Kroupis, Christos and Lohmander, Maria and Šprongl, Luděk and Panteghini, Mauro and Boursier, Guilaine",
year = "2021",
abstract = "The ISO 15189:2012 standard section 5.9.1 requires laboratories to review results before release, considering quality control, previous results, and clinical information, if any, and to issue documented procedures about it. While laboratory result reporting is generally regarded as part of the post-analytical phase, the result release process requires a general view of the total examination process. Reviewing test results may follow with troubleshooting and test repetition, including reanalyzing an individual sample or resampling. A systematic understanding of the result release may help laboratory professionals carry out appropriate test repetition and ensure the plausibility of laboratory results. In this paper, we addressed the crucial steps in the result release process, including evaluation of sample quality, critical result notification, result reporting, and recommendations for the management of the result release, considering quality control alerts, instrument flags, warning messages, and interference indexes. Error detection tools and plausibility checks mentioned in the present paper can support the daily practice of results release.",
publisher = "Elsevier",
journal = "Clinica Chimica Acta",
title = "Improving the laboratory result release process in the light of ISO 15189:2012 standard",
volume = "522",
pages = "167-173",
doi = "10.1016/j.cca.2021.08.013"
}

Çubukçu, H. C., Vanstapel, F., Thelen, M., Bernabeu-Andreu, F. A., Van Schrojenstein Lantman, M., Brugnoni, D., Mesko Brguljan, P., Milinković, N., Linko, S., Vaubourdolle, M., O'Kelly, R., Kroupis, C., Lohmander, M., Šprongl, L., Panteghini, M.,& Boursier, G.. (2021). Improving the laboratory result release process in the light of ISO 15189:2012 standard. in Clinica Chimica Acta
Elsevier., 522, 167-173.
https://doi.org/10.1016/j.cca.2021.08.013

Çubukçu HC, Vanstapel F, Thelen M, Bernabeu-Andreu FA, Van Schrojenstein Lantman M, Brugnoni D, Mesko Brguljan P, Milinković N, Linko S, Vaubourdolle M, O'Kelly R, Kroupis C, Lohmander M, Šprongl L, Panteghini M, Boursier G. Improving the laboratory result release process in the light of ISO 15189:2012 standard. in Clinica Chimica Acta. 2021;522:167-173.
doi:10.1016/j.cca.2021.08.013 .

Çubukçu, Hikmet Can, Vanstapel, Florent, Thelen, Marc, Bernabeu-Andreu, Francisco A., Van Schrojenstein Lantman, Marith, Brugnoni, Duilio, Mesko Brguljan, Pika, Milinković, Neda, Linko, Solveig, Vaubourdolle, Michel, O'Kelly, Ruth, Kroupis, Christos, Lohmander, Maria, Šprongl, Luděk, Panteghini, Mauro, Boursier, Guilaine, "Improving the laboratory result release process in the light of ISO 15189:2012 standard" in Clinica Chimica Acta, 522 (2021):167-173,
https://doi.org/10.1016/j.cca.2021.08.013 . .