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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

Masyago A.V.

Vector Best Ltd

Moshkin A.V.

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

Search for approaches to solving the problem of between-reagent-lot variation in the realities of Russian laboratory medicine. Opinion paper

Authors:

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

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Journal: Laboratory Service. 2021;10(3): 65‑68

DOI: 10.17116/labs20211003165

Views: 397

Downloaded: 28

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To cite this article:

Kurashova MB, Tivanova EV, Roitman AP, Bugrov AV, Saveliev LI, Masyago AV, Moshkin AV. Search for approaches to solving the problem of between-reagent-lot variation in the realities of Russian laboratory medicine. Opinion paper. Laboratory Service. 2021;10(3):65‑68. (In Russ.)
https://doi.org/10.17116/labs20211003165

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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. BLV can become a source of clinically significant bias. A step-by-step approach to creating protection against the influence of BLV on patient results in the realities of Russian laboratory medicine is proposed.

Keywords:

reagent kits
between-reagent-lot variation
protection

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

Masyago A.V.

Vector Best Ltd

Moshkin A.V.

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

Received:

21.08.2021

Accepted:

12.09.2021

List of references:

  1. 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 = Laboratornaya sluzhba. 2020;9(3):8-15. (In Russ.). https://doi.org/10.17116/labs202090318
  2. Hillebrand JJ, Wickenhagen WV, Heijboer AC. Improving Science by Overcoming Laboratory Pitfalls With Hormone Measurements. J Clin Endocrinol Metab. 2021;106(4):e1504-e1512. https://doi.org/10.1210/clinem/dgaa923
  3. Ambade V, Misra P, Vashum Y, Sharma M, Mukherjee B, Bhatia K, Puliyath M, Rasu P, Indra PB, Sibin MK. Analysis of short-term variation and long-term drift during reagent kit lot change in an NABL accredited clinical biochemistry laboratory. J Med Biochem. 2021;40(1):92-98.  https://doi.org/10.5937/jomb0-25597
  4. CLSI EP26-A User Evaluation of Between-Reagent Lot Variation; Approved Guideline. CLSI. September 2013.
  5. Theodorsson E, Magnusson B, Leito I. Bias in clinical chemistry. Laboratory Service. 2018;7(3):41-58  https://doi.org/10.17116/labs20180703141

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