Search for quality criteria for various vacuum systems for blood collection to assess impact on preanalytic and analytical characteristics, on clinical value of laboratory parameters (pilot study)

The objectives of the study were: to search for quality criteria for vacuum systems for collecting blood of Russian and foreign production at the preanalytic and analytical stages, to compare them and to study the possible impact on the results of certain biochemical and immunochemical analytes. Material and methods. 88 gel vacuum systems for blood collection from different manufacturers were studied: Vacuette (Аustria), ВD Vacutainer SST (USА), GL 795 (China), Zdravmedtech (Russia) for preanalytic characteristics in accordance with the requirements of Russian state standards. The frequency of defects in clinical departments and after centrifugation in the laboratory Department was visually evaluated. At the analytical stage, the comparative characteristics of hemolysis, lipemia and ictericity indices in gel vacuum systems for blood collection were carried out. The effects of the hemolysis index on biochemical analytes – alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDG), direct bilirubin, serum potassium (K⁺), and immunochemical analytes – folic acid and neuron-specific enolase (NSE) in reference and pathological intervals was studied. Results. A summary analysis of defects in vacuum system from different manufacturers at the preanalytic stage is presented. In test tubes located in clinical departments, the largest number of defects in labels, appearance, and separation gel was detected in manufacturers from the USA, China, and Russia. The analysis of total defects of vacuum systems in the laboratory department showed the largest number of detected defects in tubes of Chinese (35 %) and Russian (34 %) production, the smallest number – in tubes manufactured in Austria (16 %) and the USA (16 %). The number of hemolized samples from 10 to 50H was: manufacturers from China – 5, from Austria – 4, from the USA – 6, from Russia – 8 samples. The hemolysis index above 10 and <50 was 4.54 % for Austrian manufacturers. Other manufacturers showed values of the hemolysis index above the target – 5.2 % (WG LEPS). The comparative characteristic of lipemia and ictericity indices in gel vacuum systems for blood collection from different manufacturers is carried out. For the ALT, LDG, and K⁺ measurement group, the discrepancies were minimal, and the maximum deviation in ALT values was 2 %. When determining the AST, a positive maximum offset (12.47 %) was observed in Russian-made test tubes. The greatest deviation between different tube manufacturers was observed when determining conjugated bilirubin. So, in test tubes of Chinese production – minus 12.25 %, Russian production – plus 9.15 %. It was found that the hemolysis index of more than 19 conventional units in gel vacuum systems from different manufacturers had an effect on LDG levels. The facts of increasing NSE indicators without increasing the hemolysis index were revealed, which indicates that there is another mechanism for increasing NSE that needs to be studied. Conclusion. Some directions for searching for quality criteria for evaluating vacuum systems from different manufacturers for evaluating certain biochemical (LDG) and immunochemical (NSE) analytes are suggested. It is possible that some biochemical (LDG) and immunochemical (NSE) analytes that are in pathological values can serve as criteria for the quality of vacuum systems if these data are checked more thoroughly.

blood analyses, blood collection tubes, patient safety, preanalytical, preanalytical hemolysis, defects, plasma, plasma quality, hemolysis index, lipemia index, isterichnost index, ALT, AST, K⁺, DBil, LDG, folates, NSE, vacuum tubes

1. Bugrov A. V., Dolgov V. V., Kazakov S. P., Lugovskaya S. A., Mironova I. I., Pochtar M. E., Rakova N. G., Roitman A. P., Romanova L. A., Selivanova A. V., Sosnin D. Yu., Shabalova I. P., Shevchenko O. P., Schetnikovich K. A. Clinical laboratory diagnostics. M.: Labdiag; 2017 (In Russ.) https://elibrary.ru/item.asp?id=38495001. ISBN: 978–5–7249–2608–9

2. Kudryashov S. R., Kanischev Yu.N., Putkov S. B., Esaulenko N. B., Karpov V. O., Ovcharenko V. P., Izgorodin A. S., Jukova E. E., Suslova L. A., Parshakova E. V. Instructions for the preanaiytic stage (the procedure for taking, storing and transporting) with biomaterial for laboratory research in the center of clinical laboratory diagnostics of the MMCH named after academician N. N. Burdenko. M.: Eco-Press; 2016 (In Russ.) https://elibrary.ru/download/elibrary_36285301_31554849.pdf

3. State standard ISO-6710–2011 Single-use containers for venous blood specimen collection. Technical requirements and test methods (State Standard is put into effect by the Order of Federal Agency for Technical Regulation and Metrology, dec. 13, 2011. N 1379-st

4. State standard ISO 10993–4–2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood

5. Horovskaya L. A., Danilova D. G., Shmidt I. O. Experience in Validation of UNIVAC vacuum tubes in a medical laboratory. Handbook of the head of CLD = Spravochnik zaveduyuschego CLD. 2017; 9: 316. (In Russ.) https://elibrary.ru/item.asp?id=29947592

6. Moshkin A. V. Assessment of the degree of hemolysis on the biochemical analyzer VITROS 5.1FS – a possible indicator of the quality of sampling and transportation. Laboratory = Laboratoriya. 2011; 3: 18–19. (In Russ.)

7. Plebani M., Chiozza M. L., Sciacovelli L. Towards harmonization of quality indicators in laboratory medicine. Clin. Chem. Lab. Med. 2013; 51 (1): 187–195.] https://www.ncbi.nlm.nih.gov/pubmed/23023884. DOI: 10.1515/cclm-2012–0582.

8. Gawria G., Tillmar L., Landberg E. A comparison of stability of chemical analytes in plasma from the BD Vacutainer ® Barricor™ tube with mechanical separator versus tubes containing gel separator. J. Clin. Lab. Anal. 2019 Oct 11: e23060. https://www.ncbi.nlm.nih.gov/pubmed/31605419. doi: 10.1002/jcla.23060.

9. Klimenkova O. A., Berestovskaya V. S., Laricheva E. S. The index of hemolysis: from discussion to decision by the breakdown of pre-analytical quality. Modern laboratory = Sovremennaya laboratoriya. 2013; 3 (16): 38–40. (In Russ.) https://elibrary.ru/download/elibrary_20726036_38002450.pdf

10. Klimenkova O. A., Emanuel A. V. Quality indicators: the conditions for the benchmarking of laboratory services. Bulletin of Roszdravnadzor = Vestnik roszdravnadzora. 2014; 1: 14–229. (In Russ.) https://elibrary.ru/download/elibrary_21243683_88811471.pdf

11. State standard R ISO 53022.2–2008 Clinical laboratory technologies. Requirements for the quality of clinical laboratory research. Part 2. Evaluation of analytical reliability of research methods (accuracy, sensitivity, specificity).

12. State standard R 53079.4–2008 Clinical laboratory technologies. Quality assurance of clinical laboratory tests. Part 4. Rules for conducting of preanalytical stage

13. Raffick AR Bowen, Alan T. Remaley. Interferences From Blood Collection Tube Components on Clinical Chemistry Assays. Biochem. Med. (Zagreb). 2014; 24 (1): 31–44. DOI: 10.11613/BM.2014.006.

14. Menshikov V. V. Clinical patient safety and reliability of laboratory information (lecture). Clinical laboratory diagnostics = Clinicheskaya laboratornaya diagnostika. 2013; 6: 29–36. (In Russ.) https://elibrary.ru/download/elibrary_20237178_19722573.pdf

15. Horovskaya L. A., Shmidt I. O., Kovalevskaya S. N. Comparison of results of biochemical blood tests of patients using vacuum tubes Lind-vac (Estonia) and Greiner (Austria). Handbook of the head of CLD = Spravochnik zaveduyuschego CLD. 2015; 2: 9–19. (In Russ.) https://elibrary.ru/item.asp?id=23609803

16. Kavsak PA., Mansour M., Wang L., Campeau S., Clark L., Brooks D., Trus M. Assessing pneumatic tube systems with patient-specific population and laboratory derived criteria. Clin. Chem. 2012; 58: 792–795. DOI: 10.1002/jcla.23060.