Between-Reagent Lot Variation or matrix effect of Control Material?

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Tivanova E.V.

Central Research Institute for Epidemiology

Telminova L.V.

Central Research Institute for Epidemiology

Kurashova M.B.

Central Research Institute for Epidemiology

Between-Reagent Lot Variation or matrix effect of Control Material?

Authors:

Tivanova E.V., Telminova L.V., Kurashova M.B.

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Journal: Laboratory Service. 2020;9(3): 49‑53

DOI: 10.17116/labs2020903149

Views: 1615

Downloaded: 83

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To cite this article:

Tivanova EV, Telminova LV, Kurashova MB. Between-Reagent Lot Variation or matrix effect of Control Material?. Laboratory Service. 2020;9(3):49‑53. (In Russ.)
https://doi.org/10.17116/labs2020903149

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It is known that between-reagent lot variation can lead to clinically significant bias. Simultaneous, comparative testing of patient samples on the current and new lots of reagents allows to assess the significance of the bias detected on the measurement results of control materials, and determine its cause. One of the variants of between lot reagent variation for determination of albumin in urine by immunoturbidimetric method, when the displacement is observed only on the results of control measurements, is presented in this publication.

Keywords:

QC

control material

commutability

matrix-effect

bias

Authors:

Tivanova E.V.

Central Research Institute for Epidemiology

Telminova L.V.

Central Research Institute for Epidemiology

Kurashova M.B.

Central Research Institute for Epidemiology

Received:

23.04.2020

Accepted:

27.07.2020

List of references:

Teodorsson E, Magnusson B, Leito I. Cmeshenie v klinicheskoy khimii. Laboratornaya sluzhba. 2018;7(3):41-58. (In Russ.). https://doi.org/10.17116/labs2018703141
CLSI EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline. CLSI. September 2013.
Instruktsiya k kontrolnomu materialu BIO-RAD Liquichek Chemistry Control Levels1 and 2. (In Russ.). https://www.myeinserts.com
Ceriotti F, Fernandez-Calle P, Klee GG. Kriterii otneseniya laboratornih pokazateley k odnoy iz modeley trebovaniy k analiticheskomu kachestvu, opredelennih na Pervoy strategicheskoe konferentsii EFLM. Laboratornaya sluzhba. 2019;8:1:93-100. (In Russ.).
GOST P53022.2-2008 Trebovaniya k kachestvu klinicheskik laboratornih issledovaniy. Chast 2. Otsenka analiticheskoy nadezhnosti metodov issledovaniya (tocknost, chuvstvitelnost, spetsifichnost). (In Russ.).
Moshkin AV, Dolgov VV, Egorushkin AA, Egorushkina YuO, Fedorova MM. Upravlenie kachestvom klinicheskih laboratornih issledovaniy. Uchebnik «Klinicheskaya laboratornaya diagnostika»: v 2 t. Pod red. prof. V.V. Dolgov. M. OOO «Labdiag», 2018. (In Russ.).

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