Comparative study of the quality of screening of donated blood for the presence of molecular markers of viral infections

Introduction. Transfusions of donor blood components are indispensable in providing medical care for a large number of conditions and diseases. Therefore, the issue of improving the quality and safety of transfusions is relevant for healthcare worldwide.

Aim — to assess the quality of donor blood screening for HIV, HBV and HCV by PCR in several Russian blood banks.

Methods: PCR, CLIA and ELISA.

Results. A study was conducted to assess the quality of molecular screening of donated blood in medical organizations, which was carried out in two stages. Two different kits of control samples for each project stage were created and delivered to the project participants (blood banks). Each kit contained samples with or without HBV DNA / HIV RNA / HCV RNA. The first stage’s kit contained 40 samples, the second one — 10 samples. Thus, project participants performed 13 series of test runs (520 tests) on the first stage and 8 series of runs (80 tests) on the second one. The number kits copies sent to one participant was determined by the participant’s laboratory equipment. Participants who used the Cobas performed 330 tests, of which 255 were incorrect. Participants using the Procleix performed 40 tests, and 29 tests gave a false result. 140 samples were tested by AmpliSens, and results in 86 cases were incorrect. One participant used Vector-Best test kits and performed 40 tests, 16 of which returned incorrect. In total, 355  samples containing HBV DNA, 121  samples containing HCV RNA, and 82  samples containing HIV RNA were provided to project participants. HBV DNA was detected in 191 (53.8 %) of 355 samples, HCV RNA was detected in 119 (98.3 %) of 121 samples, and HIV RNA was detected in 76 (92.7 %) of 82 samples.

Conclusion. The proportion of inconsistencies in the results increased depending on the decrease in the concentration of the marker being determined. Participants demonstrated the best performance results if they were using branded equipment. Such participants received the least inconsistencies. The biggest issue concerned HBV DNA detection due to a lower viremia of this pathogen. All samples with low HBV DNA levels contained anti-HBc, which indicates potential latent HBV. Therefore, it is appropriate to include anti-HBc in the routine screening of donated blood.

1. Beloborodov V.A., Kelchevskaya Ye.A. Transfusion of blood and its components. Irkutsk; 2020. (In Russian).

2. Busch M.P., Bloch E.M., Kleinman S. Prevention of transfusion-transmitted infections. Blood. 2019; 133(17): 1854–64. DOI: 10.1182/blood-2018-11-833996.

3. Fiedler S.A., Oberle D., Chudy M., et al. Effectiveness of blood donor screening by HIV, HCV, HBV‐NAT assays, as well as HbsAg and anti‐HBc immunoassays in Germany (2008–2015). Vox Sang. 2019; 114(5): 443–50. DOI: 10.1111/ vox.12770.

4. Knipe D.M., Howley P.M. (eds). Fields Virology. Sixth edition; Chapter 47. Retroviridae. Philadelphia: Lippincott Williams Wilkins; 2013; Vol. 2: 1424–73.

5. Gaynova I.A., Bazhan S.I., Likhoshvay V.A., et al. Mathematical modeling possibilities in HIV-1 infection study. Rossijskiy immunologitcheskiy zurnal. 2015; 9(4): 379–99. (In Russian).

6. Tupoleva T.A. Occult form of infection caused by the hepatitis B virus. Gematologiya I transfuziologiya. 2018; 63(2): 166-73. DOI: 10.25837/ HAT.2018.68.2.007. (In Russian).

7. Yaroslavtseva N.G., Tikhomirov D.S., Nikolayeva L.I., Dedova A.V. Low concentrations of hepatitis C virus RNA in serologically mild infection. Voprosy virusologii. 2019; 64(1): 30–5. DOI: 10.18821/0507-4088-2019-64-1-30-35. (In Russian).

8. Federal State Statistics Service. Healthcare. URL: https://rosstat.gov.ru/folder/13721/. (In Russian).

9. Valchugova L.M., Valchugova Y.S., Yampolskaya T.D. The relevance of the use of molecular biological methods (PCR) for the detection of hepatitis B virus DNA in seronegative donor blood during parallel ELISA screening for hBsAg. Eurasian Union of Scientists. 2019; 3(60): 4–6. DOI: 10.31618/ESU.2413- 9335.2019.5.60.4-6. (In Russian).

10. Eremeyeva Zh.G., Fazylov V.Kh. Detection of occult hepatitis B during donors’ blood screening. Vestnik Rossiyskogo gosudarstvennogo meditsinskogo universiteta. 2017; 1: 66–9. (In Russian).

11. Ministry of Health of the Russian Federation Directive N 1166n “Approval of procedure of medical examination blood donor, a list of medical contraindications (temporary and permanent) for blood donation, the withdrawal from blood donation period”". URL: https://base.garant.ru/74961670/. (In Russian).

12. Availability, safety and quality of blood products. Report of the Director-General to the 75th World Health Assembly. WHO, April 12, 2022. URL: https://apps. who.int/gb/ebwha/pdf_fi les/WHA75/A75_40-ru.pdf. (In Russian).

13. Tankayeva Kh.S., Iluyeva A.K., Zhiburt E.B. Blood-borne infection in blood donors and recipients in Dagestan. Transfuziologiya. 2020; 21(1): 50–6. (In Russian).