Problems of infectious safety of donor blood components
Authors: Novak V.L. , Primak S.V. , Tarasyuk O.O. , Myskiv I.M. , Gorban I.M. 
Published: October 2020

Objective. To analyze the donor blood screening parameters of the blood service of Ukraine.
Materials and methods. Quarterly and annual reports of blood service institutions of Ukraine for 2000-2019 concerning detection of markers of hepatitis B, C, syphilis and HIV ½ among donors of blood and its components.
Results and discussion. One of the main problems of the blood service of Ukraine at the present stage is the high prevalence of blood-borne infections among donors. As a result of the measures on infectious safety, which were reflected in the Law of Ukraine “On Blood Donation and Its Components” (1995), as well as in 12 orders of the Ministry of Health of Ukraine and instructional materials during the years of independence the level of infection among donors has decreased significantly. Despite the outlined positive, the probability of infection of the recipient during transfusions still exists today. Therefore, transfusions of blood components should be treated as a serious invasive medical operation, which can have both immediate and long-term consequences with possible infection of the patient.
From the dynamics of the prevalence of HIV markers among donors of blood and its components (regular and reserve) per 100 thousand donations, the highest rate of infection (153 cases) was in 2009. Among the regular donors it was 3.4 times lower than among reserve donors. The lowest rate (61 cases per 100 thousand donations) was in 2019. Infection among the regular donors was 7.6 times lower than among reserve donors.
Similar dynamics was observed for the viral hepatitis B. The highest rate (1555 cases per 100 thousand donations) was in 2000 and it was 2.8 times lower in regular donors compared to reserve donors. The lowest rate (385 cases per 100 thousand donations) was established in 2018, the number of regular donors infected in 2018 was 15.4 times lower than the reserve donors.
Analyzing the dynamics of the prevalence of hepatitis C markers it was found that the highest rate (3107 cases per 100 thousand donations) was in 2003. Regarding the infection of regular donors it was 3 times lower than among reserve donors. The lowest rate (539 cases per 100 thousand donations) was observed in 2019 and it also was 3.8 times lower among the regular donors.
The dynamics of the prevalence of syphilis also indicates a significant decrease in infection among donors in 2019. In 2003 its rate was the highest for the entire observation period – 1493 cases per 100 thousand donations, whereas in 2019 its rate was 450 cases (decrease by 69.9 %). Among the regular donors it was 2.4 times lower in 2003, and 10.3 times lower in 2019 – as compared to the reserve donors.
Analyzing the prevalence of markers of HIV infection, hepatitis B, C and syphilis, it was found that virtually all of these infections in 2019 had the highest rates in the Kirovograd oblast, indicating an extremely high level of infection among donors, and consequently among the general adult population. On the contrary, the lowest prevalence of blood-borne infections was in Sumy oblast. As for the regular and reserve donors ratio – in 2018 in Kirovograd oblast the percentage of regular donors was 4.5 %, and in Sumy region – 64.7 %.
In addition to HIV, hepatitis B, C and syphilis, and a list of other pathogens that also can be transmitted with blood components and blood products there are new challenges emerging in 2019 with the SARS-CoV-2 along with many unresolved questions about the properties of the new virus. On August 23, the U.S. Food and Drug Administration approved the use of plasma from recovered patients for the treatment of COVID-19. With this regard since work on the possibility of using plasma for medical purposes is carried out also in Ukraine, the blood service urgently needs to develop regulations that will clearly define the route of such plasma, starting with the collection and until the actual use in the clinic.
According to the screening of donor blood by enzyme-linked immunosorbent assay test systems, which may produce both false-negative and false-positive results, for the last 19 years the blood service of Ukraine suspended for life 557,468 persons with a total number of donors in 2018 of 385,353.
In order to preserve the donor contingent, it is necessary to resume the work of the Center for Infectious Safety of Donor Blood, whose task was to perform pre-tender tests of the test systems using low-volume and seroconversion standard blood serum samples. In addition, it is necessary to develop measures to bring back the life-long suspended donors after repeated examination in 6 months by the high quality test systems.
Conclusions. Without the introduction of methods for detection of hemotransmissible infections by polymerase chain reaction in blood service facilities, it is almost impossible to guarantee the infectious safety of donor blood components and blood plasma preparations.