Affiliation:
1. National Medical Research Center for Hematology
2. Republican Blood Transfusion Station
3. Samara Regional Blood Transfusion Station
4. Mordovian Republican Blood Transfusion Station
5. Blood Transfusion Station of the Ministry of Health of the Krasnodar Territory
6. Blood Transfusion Station in the Rostov Region
7. Smolensk Blood Center
8. I.M. Sechenov First Moscow State Medical University (Sechenov University)
9. Novosibirsk Blood Center
Abstract
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.
Publisher
National Medical Research Center of Hematology of the Ministry of Health of the Russian Federation
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