Development of preanalytical criteria assessment of quality of vacuum blood collection systems affecting clinical examination of patients

This paper presents comparative studies of preanalytical quality indices of vacuum gel systems (VGS) from four manufacturers, i.e., GL 795 (China), Vacuette (Austria), BD Vacutainer SST (USA) and Zdravmedtech (Russia). The analysis of the number of qualitative defects of the preanalytic phase of blo...

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Autores principales:	S. P. Kazakov, L. A. Suslova
Formato:	article
Lenguaje:	RU
Publicado:	SPb RAACI 2020
Materias:	blood analyses blood collection tubes patient safety preanalytical criteria defects preanalytical hemolysis plasma plasma quality hemolysis index lipemia index icterus index ldh vacuum tubes Immunologic diseases. Allergy RC581-607
Acceso en línea:	https://doaj.org/article/ec6e9bc6a0a4445f8068cc88e37a5b0e
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spelling	oai:doaj.org-article:ec6e9bc6a0a4445f8068cc88e37a5b0e2021-11-18T08:03:49ZDevelopment of preanalytical criteria assessment of quality of vacuum blood collection systems affecting clinical examination of patients1563-06252313-741X10.15789/1563-0625-DOP-1920https://doaj.org/article/ec6e9bc6a0a4445f8068cc88e37a5b0e2020-05-01T00:00:00Zhttps://www.mimmun.ru/mimmun/article/view/1920https://doaj.org/toc/1563-0625https://doaj.org/toc/2313-741XThis paper presents comparative studies of preanalytical quality indices of vacuum gel systems (VGS) from four manufacturers, i.e., GL 795 (China), Vacuette (Austria), BD Vacutainer SST (USA) and Zdravmedtech (Russia). The analysis of the number of qualitative defects of the preanalytic phase of blood collection in vacuum gel tubes at the inpatient departments and in Department of Clinical Chemistry (preanalytic laboratory), in accordance with adopted criteria based on Russian industry standards, which are implemented with European indices of pre-analytic stage. The obtained results allowed us to identify a number of qualitative defects at pre-analytic stage for the vacuum gel systems from each manufacturer, including to summarize the data on number of these defects. Based on these results, the most common defects in each of the VGS presented by manufacturers are formulated. The results obtained can be used by manufacturers to improve the quality (structures) of the mentioned vacuum gel tubes.The results of the comparative characteristics of VGS of different manufacturers were evaluated by their influence on the indexes of hemolysis (IH), ictericity, lipemia. The resulting indices of ictericity and lipemia do not allow to use them as criteria for assessing quality of the gel systems. The frequency of IH occurrence in serum at > 50 conventional units in VGS of different manufacturers was studied. It was revealed, that IH in the range from 10 to 50 conventional units and more, can be used as a criterion of VGS quality.Comparison of routine biochemical parameters in VGS of different manufacturers, i.e., alanine aminotransferase, aspartate aminotransferase, direct bilirubin, lactate dehydrogenase (LDH), serum K+, was also carried out. It was found that the largest deviations from the average value were obtained for aspartate aminotransferase indices of more than 12.47% in Russian test tubes, and for direct bilirubin of more than 12.25% in Chinese test tubes and more than 9.15% in Russian test tubes. The study showed influence of IH upon quantitative values of lactate dehydrogenase for VGS from different manufacturers. It is proposed to use lactate dehydrogenase as an analyte. On this basis, it is possible to recommend a comparative quality assessment of vacuum gel systems, with IH cutoff level of more than 19 conventional units. It remains relevant to search for other analytes that can be used to assess the quality of VGS from different manufacturers. Some areas of research in biochemical testing are outlined. Preliminary data are obtained on usage of vacuum systems from different manufacturers for quality assessment, as well as conditions for performing these tests, along with the level of the hemolysis index of more than 10 conventional units.S. P. KazakovL. A. SuslovaSPb RAACIarticleblood analysesblood collection tubespatient safetypreanalytical criteriadefectspreanalytical hemolysisplasmaplasma qualityhemolysis indexlipemia indexicterus indexldhvacuum tubesImmunologic diseases. AllergyRC581-607RUMedicinskaâ Immunologiâ, Vol 22, Iss 3, Pp 585-598 (2020)
institution	DOAJ
collection	DOAJ
language	RU
topic	blood analyses blood collection tubes patient safety preanalytical criteria defects preanalytical hemolysis plasma plasma quality hemolysis index lipemia index icterus index ldh vacuum tubes Immunologic diseases. Allergy RC581-607
spellingShingle	blood analyses blood collection tubes patient safety preanalytical criteria defects preanalytical hemolysis plasma plasma quality hemolysis index lipemia index icterus index ldh vacuum tubes Immunologic diseases. Allergy RC581-607 S. P. Kazakov L. A. Suslova Development of preanalytical criteria assessment of quality of vacuum blood collection systems affecting clinical examination of patients
description	This paper presents comparative studies of preanalytical quality indices of vacuum gel systems (VGS) from four manufacturers, i.e., GL 795 (China), Vacuette (Austria), BD Vacutainer SST (USA) and Zdravmedtech (Russia). The analysis of the number of qualitative defects of the preanalytic phase of blood collection in vacuum gel tubes at the inpatient departments and in Department of Clinical Chemistry (preanalytic laboratory), in accordance with adopted criteria based on Russian industry standards, which are implemented with European indices of pre-analytic stage. The obtained results allowed us to identify a number of qualitative defects at pre-analytic stage for the vacuum gel systems from each manufacturer, including to summarize the data on number of these defects. Based on these results, the most common defects in each of the VGS presented by manufacturers are formulated. The results obtained can be used by manufacturers to improve the quality (structures) of the mentioned vacuum gel tubes.The results of the comparative characteristics of VGS of different manufacturers were evaluated by their influence on the indexes of hemolysis (IH), ictericity, lipemia. The resulting indices of ictericity and lipemia do not allow to use them as criteria for assessing quality of the gel systems. The frequency of IH occurrence in serum at > 50 conventional units in VGS of different manufacturers was studied. It was revealed, that IH in the range from 10 to 50 conventional units and more, can be used as a criterion of VGS quality.Comparison of routine biochemical parameters in VGS of different manufacturers, i.e., alanine aminotransferase, aspartate aminotransferase, direct bilirubin, lactate dehydrogenase (LDH), serum K+, was also carried out. It was found that the largest deviations from the average value were obtained for aspartate aminotransferase indices of more than 12.47% in Russian test tubes, and for direct bilirubin of more than 12.25% in Chinese test tubes and more than 9.15% in Russian test tubes. The study showed influence of IH upon quantitative values of lactate dehydrogenase for VGS from different manufacturers. It is proposed to use lactate dehydrogenase as an analyte. On this basis, it is possible to recommend a comparative quality assessment of vacuum gel systems, with IH cutoff level of more than 19 conventional units. It remains relevant to search for other analytes that can be used to assess the quality of VGS from different manufacturers. Some areas of research in biochemical testing are outlined. Preliminary data are obtained on usage of vacuum systems from different manufacturers for quality assessment, as well as conditions for performing these tests, along with the level of the hemolysis index of more than 10 conventional units.
format	article
author	S. P. Kazakov L. A. Suslova
author_facet	S. P. Kazakov L. A. Suslova
author_sort	S. P. Kazakov
title	Development of preanalytical criteria assessment of quality of vacuum blood collection systems affecting clinical examination of patients
title_short	Development of preanalytical criteria assessment of quality of vacuum blood collection systems affecting clinical examination of patients
title_full	Development of preanalytical criteria assessment of quality of vacuum blood collection systems affecting clinical examination of patients
title_fullStr	Development of preanalytical criteria assessment of quality of vacuum blood collection systems affecting clinical examination of patients
title_full_unstemmed	Development of preanalytical criteria assessment of quality of vacuum blood collection systems affecting clinical examination of patients
title_sort	development of preanalytical criteria assessment of quality of vacuum blood collection systems affecting clinical examination of patients
publisher	SPb RAACI
publishDate	2020
url	https://doaj.org/article/ec6e9bc6a0a4445f8068cc88e37a5b0e
work_keys_str_mv	AT spkazakov developmentofpreanalyticalcriteriaassessmentofqualityofvacuumbloodcollectionsystemsaffectingclinicalexaminationofpatients AT lasuslova developmentofpreanalyticalcriteriaassessmentofqualityofvacuumbloodcollectionsystemsaffectingclinicalexaminationofpatients
_version_	1718422325083242496

Development of preanalytical criteria assessment of quality of vacuum blood collection systems affecting clinical examination of patients

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