Analysis of comparison of laboratory results obtained from Acti-Fine vacuum tubes (Granat Bio Tech, Russia) and reference tubes BD Vacutainer (Becton Dickinson, USA) using international CLSI GP-34A guidelines

Panin V.V.

Centralized Laboratory and Diagnostic Service of the I.M. Sechenov First Moscow State Medical University Clinical Center

Danilova E.V.

Granat Bio Tech LLC

Kovalevskaya S.N.

Academician I.P. Pavlov First St. Petersburg State Medical University

ORCID: 0000-0002-6898-286X

Analysis of comparison of laboratory results obtained from Acti-Fine vacuum tubes (Granat Bio Tech, Russia) and reference tubes BD Vacutainer (Becton Dickinson, USA) using international CLSI GP-34A guidelines

Authors:

Panin V.V., Danilova E.V., Kovalevskaya S.N.

More about the authors

Journal: Laboratory Service. 2022;11(1): 28‑37

DOI: 10.17116/labs20221101128

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To cite this article:

Panin VV, Danilova EV, Kovalevskaya SN. Analysis of comparison of laboratory results obtained from Acti-Fine vacuum tubes (Granat Bio Tech, Russia) and reference tubes BD Vacutainer (Becton Dickinson, USA) using international CLSI GP-34A guidelines. Laboratory Service. 2022;11(1):28‑37. (In Russ.)
https://doi.org/10.17116/labs20221101128

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ISO 15189 — 2015 «Medical laboratories. Particular requirements for quality and competence» contains, among others, a requirement to verify the functional characteristics of consumables before their application in research. Using tubes from different manufacturers can lead to the uncertainty of laboratory research results. The research includes the analysis of comparability of the laboratory research results obtained from Acti-Fine vacuum blood collection tubes (Granat Bio Tech, Russia) containing a clot activator and separator gel, ethylenediaminetetraacetic acid dipotassium salt (K₂EDTA) and sodium citrate 3.2% and the results obtained from equivalent BD Vacutainer vacuum blood collection tubes (Becton Dickinson, USA). The research was based on the GP-34A and EP09-A2-IR protocols of the Clinical & Laboratory Standards Institute (CLSI).

PURPOSE OF RESEARCH

The purpose of the research is to compare the laboratory research results obtained from Acti-Fine vacuum blood collection tubes (Granat Bio Tech, Russia) containing a clot activator and gel, K₂ETDA, and sodium citrate 3.2% through the evaluation of the comparability with laboratory results obtained from reference BD Vacutainer blood collection tubes (Becton Dickinson, USA) based on the CLSI GP-34A international protocol.

MATERIALS AND METHODS

The research was based on the GP-34A and EP09-A2-IR protocols of the Clinical & Laboratory Standards Institute (CLSI). The results achieved were allocated in the range of reference intervals of 46 researched analytes.

RESULTS

The research allowed the technical and clinical validation of Acti-Fine vacuum tubes demonstrating minimum deviations compared with reference BD Vacutainer tubes, as well as giving a positive evaluation to the quality of Acti-Fine vacuum tubes (Granat Bio Tech, Russia) compared with the reference tubes and also being able to recommend them for healthcare facilities in the Russian Federation.

CONCLUSIONS

Selecting a manufacturer of blood collection systems is an important step to ensure the quality of the pre-analytical stage as it allows the uncertainty of laboratory research results to be reduced. Implementing the international approach to the validation of tubes from different manufacturers enables the right choice to be made for vacuum systems with an optimal price/quality ratio; in this case, it makes it possible for Acti-Fine vacuum tubes (Granat Bio Tech, Russia) to be recommended for healthcare facilities in the Russian Federation.

Keywords:

vacuum venous blood collection tubes

clinical

biochemical

coagulation studies

preanalytical stage

Authors:

Panin V.V.

Centralized Laboratory and Diagnostic Service of the I.M. Sechenov First Moscow State Medical University Clinical Center

Danilova E.V.

Granat Bio Tech LLC

Kovalevskaya S.N.

Academician I.P. Pavlov First St. Petersburg State Medical University

ORCID: 0000-0002-6898-286X

Received:

09.11.2021

Accepted:

10.02.2022

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