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 . .