Quality management of biosampling and data collection from women at different stages of pregnancy for the search for early biomarkers of preterm birth: predicting errors and risk management
https://doi.org/10.15829/1728-8800-2021-3107
Abstract
The main condition for ensuring effective sampling for creating a bioresource collection is quality management, which implies careful planning and predicting errors at all stages. Risk management of samples and data loss is ensured by correct logistics, circumspect algorithms and standardization of processes. Features of the logistic processes for creating biosample collection from the pregnant women are described in this article.
About the Authors
O. V. PachuliaRussian Federation
St. Petersburg
R. A. Illarionov
Russian Federation
St. Petersburg
E. S. Vashukova
Russian Federation
St. Petersburg
N. A. Yurkina
Russian Federation
St. Petersburg
M. G. Butenko
Russian Federation
St. Petersburg
T. B. Postnikova
Russian Federation
St. Petersburg
O. N. Bespalova
Russian Federation
St. Petersburg
A. S. Glotov
Russian Federation
St. Petersburg, Surgut
References
1. Forsythe LP, Carman KL, Szydlowski V, et al. Patient Engagement in Research: Early Findings from The Patient-Centered Outcomes Research Institute. Health Aff (Millwood). 2019;38(3):359-67 doi:10.1377/hlthaff.2018.05067.
2. Lippi G, Banfi G, Church S, et al. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG-PRE). Clin Chem Lab Med. 2015;53(3):357-70. doi:10.1515/cclm-2014-1051.
3. Anisimov SV, Meshkov AN, Glotov AS, Borisova AL, Balanovsky OP, Belyaev VE, Granstrem OK, Grivtsova LY, Efimenko AY, Pokrovskaya MS, Semenenko TA, Sukhorukov VS, Kaprin AD, Drapkina OM. National Association of Biobanks and Biobanking Specialists: New Community for Promoting Biobanking Ideas and Projects in Russia. Biopreserv Biobank. 2021; 19(1):73-82. doi:10.1089/bio.2020.0049.
4. Illarionov RA, Kosyakova OV, Vashukova ES, et al. Collection of samples from women at different stages of pregnancy to search for early biomarkers of preterm birth. Cardiovascular Therapy and Prevention. 2020;19(6):2708. (In Russ.) doi:10.15829/1728-8800-2020-2708.
5. Federal Law of the Russian Federation on Personal Data, Russian Federation Collection of Legislation, Jul.27, 2004. (In Russ.)
6. Federal Law of the Russian Federation on Biomedical Cell Products, Russian Federation Collection of Legislation, Jun.23, 2016. (In Russ.)
7. State Standard R ISO 14155-2014 Clinical investigation of medical devices for human subjects — Good clinical practice (IDT) (In Russ.)
8. State Standard R ISO 53079.4-2008 Medical laboratory technologies. Quality assurance of clinical laboratory research. Part 4. Rules for conducting the preanalytical stage. (In Russ.)
9. Maleina MN. Legal Status of a Biobank (Bank of Biological Human Materials). Pravo. Zhurnal Vysshey shkoly ekonomiki. 2020;1:98-117 (In Russ.) doi:10.17323/2072-8166.2020.1.98.117
10. State Standard R ISO 15189-2015 Medical laboratories. Particular requirements for quality and competence. (In Russ.)
11. Mikhailova AA, Nasykhova YuA, Muravyov AI, et al. Towards the creation of a unified glossary of Russian biobanks. Cardiovascular Therapy and Prevention. 2020;19(6):2710. (In Russ.) doi:10.15829/1728-8800-2020-2710.
12. Kozlova VA, Metelskaya VA, Pokrovskaya MS, et al. Stability of serum biochemical markers during standard long-term storage and with a single thawing. Cardiovascular Therapy and Prevention. 2020;19(6):2736. (In Russ.) doi:10.15829/1728-8800-2020-2736.
13. Moore HM, Kelly AB, Jewell SD, et al. Biospecimen reporting for improved study quality (BRISQ). Biopreserv Biobank. 2011;9:57-70. doi:1089/bio.2010.0036.
14. Pokrovskaya MS, Borisova AL, Sivakova OV, et al. Klin Lab Diagn. 2019;64(6):380-4. (In Russ.) doi:10.18821/0869-2084-2019-64-6-380-384
15. Vashukova ES, Kozyulina PY, Illarionov RA, et al. High-Throughput Sequencing of Circulating MicroRNAs in Plasma and Serum during Pregnancy Progression. Life. 2021; 11:1055. doi:10.3390/life11101055.
16. Ludupova EYu, Rinchinova NV, Dugarova RV. Preanalytical stage of laboratory research: modern optimization approaches. Zdravoohranenie. 2015;12:80-8. (In Russ.)
17. 17 Brazhnikova OV, Gavelya NV, Maykova ID. Typical errors in the preanalytical phase of laboratory. Pediatrics. Suppl Consilium Medicum. 2017;4:84-90. (In Russ.)
18. Ellervik C, Vaught J. Preanalytical variables affecting the integrity of human biospecimens in biobanking. Clin Chem. 2015;61(7):914-34. doi:10.1373/clinchem.2014.228783.
Supplementary files
Review
For citations:
Pachulia O.V., Illarionov R.A., Vashukova E.S., Yurkina N.A., Butenko M.G., Postnikova T.B., Bespalova O.N., Glotov A.S. Quality management of biosampling and data collection from women at different stages of pregnancy for the search for early biomarkers of preterm birth: predicting errors and risk management. Cardiovascular Therapy and Prevention. 2021;20(8):3107. (In Russ.) https://doi.org/10.15829/1728-8800-2021-3107