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Kurashova M.B.

Central Research Institute for Epidemiology

Tivanova E.V.

Central Research Institute for Epidemiology

Roitman A.P.

Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of the Russian Federation

Bugrov A.V.

Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of the Russian Federation

Saveliev L.I.

Ural State Medical University;
Regional Children Hospital;
Research Institute of Medical Cell Technologies

Moshkin A.V.

Association of Experts and Organizations of the Laboratory Service “Federation of Laboratory Medicine”

Assessment of the Between-Lot-to-Lot Variation effect to the laboratory results

Authors:

Kurashova M.B., Tivanova E.V., Roitman A.P., Bugrov A.V., Saveliev L.I., Moshkin A.V.

More about the authors

Journal: Laboratory Service. 2020;9(3): 8‑15

DOI: 10.17116/labs202090318

Views: 3683

Downloaded: 121

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Table of contents

ASSESSMENT OF THE BETWEEN-LOT-TO-LOT VARIATION EFFECT TO THE LABORATORY RESULTS
ASSESSMENT OF THE BETWEEN-LOT-TO-LOT VARIATION EFFECT TO THE LABORATORY RESULTS

To cite this article:

Kurashova MB, Tivanova EV, Roitman AP, Bugrov AV, Saveliev LI, Moshkin AV. Assessment of the Between-Lot-to-Lot Variation effect to the laboratory results. Laboratory Service. 2020;9(3):8‑15. (In Russ.)
https://doi.org/10.17116/labs202090318

 
 
Подписка 2025-2 (Laboratory Service)
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Between-reagent-lot variation (BLV) is a frequent challenge that limits the laboratory’s ability to produce consistent results over time. The phenomenon of BLV is characteristic of the analytical stage of laboratory process. Those who met with BLV, as a rule, had a question about what the algorithm of actions should be in relation to the new lot of reagent. In which case the new lot will not be acceptable for further use and requires a rejection, whether the BLV will have a clinically significant effect on patient outcomes or not. The paper describes the model of using internal quality control for detecting BLV and the detailed protocol CLSI EP-26A to assess the influence of BLV on laboratory results, as well as its limitations and advantages.

Keywords:

between-reagent-lot variation
bias
evaluation protocol

Authors:

Kurashova M.B.

Central Research Institute for Epidemiology

Tivanova E.V.

Central Research Institute for Epidemiology

Roitman A.P.

Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of the Russian Federation

Bugrov A.V.

Russian Medical Academy of Continuous Professional Education of the Ministry of Healthcare of the Russian Federation

Saveliev L.I.

Ural State Medical University;
Regional Children Hospital;
Research Institute of Medical Cell Technologies

Moshkin A.V.

Association of Experts and Organizations of the Laboratory Service “Federation of Laboratory Medicine”

Received:

02.07.2020

Accepted:

23.07.2020

List of references:

  1. Miller WG, Myers GL, Gantzer ML, Kahn SE, Schönbrunner ER, Thienpont LM, et al. Roadmap for Harmonization of Clinical Laboratory Measurement Procedures. Clin Chem. 2011;57:1108-1117. https://doi.org/10.1373/clinchem.2011.164012
  2. International consortium for harmonization of clinical laboratory results (ICHCLR). www.harmonization.net. Accessed 08 Feb 2017.
  3. Beastall G, Brouwer N, Quiroga S, Myers G. Traceability in laboratory medicine: a global driver for accurate results for patient care. Clin Chem Lab Med. 2017;55:1100-1108. https://doi.org/10.1515/cclm-2017-0060
  4. Greenberg N. Update on current concepts and meanings in laboratory medicine — standardization, traceability and harmonization. Clin Chim Acta. 2014;432:49-54.  https://doi.org/10.1016/j.cca.2013.12.045
  5. 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
  6. Thompson S, Chesher D. Lot-to-Lot Variation. Chemical Pathology, NSW Health Pathology; Northern Clinical School, University of Sydney, Royal North Shore Hospital, St Leonards, NSW 2065, Australia. 2018;39:2:51-60.  https://doi.org/10.1016/j.pathol.2017.12.043
  7. CLSI EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline. CLSI. September 2013.
  8. 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.). https://doi.org/10.17116/labs2019801193
  9. Fraser CG. Biological Variation: from Principles to Practice. AACC Press, 2001.
  10. Katzman BM, Ness KM, Algeciras-Schimnich A. Evaluation of the CLSI EP26-A protocol for detection of reagent lot-to-lot differences. Clin Biochem. 2017;50:768-771.  https://doi.org/10.1016/j.clinbiochem.2017.03.012
  11. Tivanova EV, Telminova LV, Kurashova MB. Mezhlotovaya variatsiya ili matriks-effekt rjntrolnogo materiala? Laboratornaya sluzhba. 2020;9:3:49-53. (In Russ.).
  12. Miller WG, Erek A, Cunningham TD, Oladipo O, Scott MG, Johnson RE. Commutability limitations influence quality control results with different reagent lots. Clin Chem. 2011;57:76-83.  https://doi.org/10.1373/clinchem.2010.148106
  13. GOST R ISO 15189-2015 Natsionalniy Standart RF, «Laboratorii meditsinskie — chastnie trebovaniya k kachestvu i kompetentnosti». (In Russ.).

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