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The risk of hepatitis B virus (HBV) transmission through blood and blood components is markedly reduced through serologic testing of each donation for the presence of HBV infection markers. Testing for hepatitis B virus surface antigen (HBsAg) is obligatory almost everywhere in the world. Several countries have also implemented testing for antibodies to hepatitis B core antigen (anti-HBc) and some perform HBV DNA tests, either in single donations or minipools of up to 96 donations. In countries with obligatory hepatitis B vaccination, the incidence of HBsAg-positive infections has been on the decline. Questions are therefore raised regarding the choice of optimal strategies for blood donor screening. In Poland, screening for hepatitis B virus surface antigen (HBsAg) to identify HBV infected donors was initiated in 1971. Pursuant to the guidelines of the Council of Europe, the analytical sensitivity of 0.13 IU/ml is required for a HBsAg diagnostic test to detect a HBsAg-positive infection. In 2005, HBV-DNA testing was added to the panel of screening tests for further reduction of HBV transmission risk through blood and blood components. The study presents the analysis of the HBV-DNA screening tests used in Poland so far. The analysis is based on the author’s doctoral dissertation and the outcome may largely contribute to the process of determining the effectiveness of the methods used up to date and to development of an optimal panel of HBV screening tests for Polish blood donors.

Transfusion of blood and blood components is one of the widely used medical procedures. The responsibility for provision of blood and blood components lies with Polish blood transfusion centers (CKiK) substantively supervised by the Institute of Hematology and Transfusion Medicine. Hospital based blood banks, hospital wards, immunohematology laboratories are supervised by CKiK. Every year approximately 600 thousand people donate blood, more than 75% of which are regular donors. The annual number of donations is maintained at a constant level of about 1.3 million. The aim of this position paper is to present the current status, achievements and advancement in collection, preparation and testing procedures and methods used to obtain the best possible quality blood components dedicated for clinical use. The aim is also to show the structure of blood transfusion service in Poland. Collaboration of all organizational units involved in transfusion medicine is crucial for providing high quality health care for patients. Polish transfusiologists and blood transfusion officers have largely contributed to transfusion science with numerous publications and significant research work. The implementation of novel methods and ongoing research positions Polish blood transfusion service among those of highly developed countries.

The new coronavirus — SARS-CoV-2 infections have recently become the main epidemiological and clinical challenge worldwide (Poland included). This article is based on the presentation entitled “Hematology and transfusion medicine and COVID-19” given/conferred during the webinar in May 2020. The aim was to introduce the procedure for diagnosing the new coronavirus infection. The procedure highlights the aspects of the pre-analytical and analytical phase that are critical for the quality of the performed tests and affected by both the commissioning and test-performing personnel. On the basis of current literature, further recommendations for the improvement of molecular diagnostics of SARS-CoV-2 are also presented.

Nucleic acid testing (NAT) was implemented in Poland in 1999 for screening of plasma for fractionation and for all blood donors in 2002. To analyze seronegative NAT‐positive samples representing hepatitis C virus (HCV) window‐period (WP) in the years 2000 to 2016 and to determine infection outcome. We analyzed results of 17 502 739 donations screened in minipools (6‐48) or individually. Index samples underwent viral load (VL) quantification, genotyping and Ag, and anti‐HCV re‐testing using chemiluminescence (CMIA), electrochemiluminescence (ECLIA), and fourth‐generation enzyme‐linked immunosorbent assay (IV EIA) assays. HCV‐seronegative infections were identified in 126 donations (7.2/mln donations; 95% confidential intervals, 6.0‐8.6). Frequency of NAT yields was decreasing over time. Of the initial 126 seronegative index cases 106 were retested: 32.1% were reactive in IV EIA, 11.3% in ECLIA, and 1.9% in CMIA. The lowest VL correlated with absent anti‐HCV and HCV Ag, while VL was highest when the antigen was detectable and then it decreased when anti‐HCV appeared at a level detectable by sensitive third generation tests while retesting. The proportion of genotype 1 was 38.9% in samples positive only for HCV RNA and 71.4% in samples that were anti‐HCV reactive in re‐testing. In parallel, genotype 3 frequency was 50% in the former group and 21% in the latter. NAT is an effective measure to limit HCV transmission by transfusion and IV EIA seems to have higher clinical sensitivity than ECLIA. Samples representing likely successive phases of early HCV infection were characterized by different genotype distribution probably due to very early elimination of genotype 3., Highlight NAT is highly effective in prevention of transmission of HCV seronegative infections.In nearly 7% of followed up donors antibodies appeared later than 50 days after index donation.The highest clinical sensitivity was demonstrated by the IVth generation tests.Among the third generation assays, ECLIA showed higher sensitivity than CMIA.Samples representing likely successive phases of early HCV infection demonstrated different genotype distribution.

Blood transfusion in Poland is the safest in history. High virological level of safety has been achieved mainly by improving not only the qualification of donors and methods used for donor screening, but also applying leukoreduction, pathogen reduction technology and grace period for serum.In this article, we discuss the improvement of the epidemic situation among blood donors for hepatitis B virus (HBV) and hepatitis C virus (HCV) and the increasing trend for HIV. Preliminary results of residual risk calculation for these pathogens are presented.Hepatitis E virus (HEV) and Babesia microti were considered as new factors potentially relevant for the safety of blood transfusion in our country. Due to evidence of West Nile virus (WNV) circulation in the ecosystem in Poland, it is also necessary to monitor the infections with this pathogen.In this article, it was emphasized that the reporting of all possible complications associated with transfusion and meticulous implementation of the look-back procedure play a key role for monitoring the risk of transmission of infectious agents by blood. It is especially important in view of the increasing epidemiological problems associated with emerging infectious agents.

Blood transfusion in Poland is the safest in history. High virological level of safety has been achieved mainly by improving not only the qualification of donors and methods used for donor screening, but also applying leukoreduction, pathogen reduction technology and grace period for serum.In this article, we discuss the improvement of the epidemic situation among blood donors for hepatitis B virus (HBV) and hepatitis C virus (HCV) and the increasing trend for HIV. Preliminary results of residual risk calculation for these pathogens are presented.Hepatitis E virus (HEV) and

Blood donor screening of viral markers in Poland is based on serologic testing for anti-HCV, HBsAg, anti-HIV1/2 (chemiluminescence tests) and on nucleic acid testing (NAT) for RNA HCV, RNA HIV-1 and DNA HBV performed in minipools of 6 with real-time PCR (MPX 2.0 test on cobas s201) or with TMA in individual donations (Ultrio Plus or Ultrio Elite). Donors of plasma for anti-D and anti-HBs production are tested for parvovirus B19 DNA. Before implementation tests and equipment are evaluated at the Institute of Hematology and Transfusion Medicine (IHTM). The last 20 years witnessed a decreasing trend for HBsAg in both first time and repeat donors (1%-0.3% and 0.1%-0.02% respectively). Prevalence of anti-HCV repeat reactive results was stable and oscillated around 0.8% for first time donors and 0.2% for repeat donors. Elevated prevalence of seropositive HIV infected donors was recently observed (7.5-9 cases/100,000 donors). Since respective molecular markers implementation HCV RNA was detected on average in 1/119,235 seronegative donations, HIV RNA in 1/783,821 and HBV DNA in 1/61,047. HBV NAT yields were mostly occult hepatitis B (1/80,248); window period cases were less frequent (1/255,146). The efficiency of HBV DNA detection depends on the sensitivity of the HBV DNA screening system.

The study assessed the incidence of HBV markers (HBsAg, anti-HBc, anti-HBs) important for determination of the risk of reactivation of infection, with particular interest of occult infection (presence of HBV DNA in the absence of HBsAg) in patients treated at the Institute of Hematology and Transfusion Medicine. Anti-HBc frequency was correlated with the age and sex of patients. HBsAg was detected in 16/468 examined patients, 98/468 (21%) were anti-HBc positive. HBV DNA was detected in 41/98 anti-HBc positives; in 13 simultaneously with HBsAg. 28 patients had occult HBV infection (HBV DNA+/HBsAg). Antibody to HBsAg was detected in 163/430 (38%) patients, 81 out of them on protective level (100 IU/l). It was shown that occult HBV infection occurs in approximately 6% of patients. In most of them the protective levels of anti-HBs are detected.

Since 2004 Polish blood donors have been tested for parvovirus B19 (B19V) DNA. The screening testing has been performed in donors of plasma for fractionation and anti-D and anti-HBs production and donors of erythrocytes used for immunization. AIM is to present methods of the testing, quality control and results in period 2004-2010.Testing was performed in individual donation testing (IDT) in Regional Blood Transfusion Center (RBTC) in Lublin or in pools of 24 in Institute of Haematology and Transfusion Medicine in Warsaw (IHTM). Quantitative testing with real-time PCR was preceded with nucleic acid isolation on silica based methods (Prepito Viral DNA/RNA, Chemagen and QIAamp DNA Mini Kit, QIAGEN). Amplification was performed initially with home made method and later with commercial assay (Artus Parvo B19 RG PCR Kit on Rotor Gene 6 000). In total 17 625 donations were tested: 8 539 in pools and 9 090 individually. Beside routine external quality control programmes in which both laboratories participated (Proficiency Study VQC,Amsterdam, Holand; EQA Programe, Glasgow, Scotland), panel containing negative samples, positive with very high DNA B 19V level and plasma infected with genotype 2 was prepared for RBTC in Lublin.B19V infection frequency was 1:980 donations, low viraemic donations were detected most frequently (1:1 037). It was identified only one donation with DNA load that could cause potential health risk for plasma product recipients (1:17 625). In one of the donors B 19V DNA was observed for 3 years and 3 months. In acute or persistent phase of infection no clinical or laboratory symptoms (morphology of peripheral blood, ALT) were observed. Due to risk of underestimation of viral load connected with viral genome polymorphism all donations with B19V positive result were not allowed to be clinically used.

The results of HCV genotype distribution between 1995 and 2007 in Polish blood donors were analyzed. Special attention was drawn into the analysis of HCV polymorphism isolated from blood donors in the early phase of infection (RNA HCV positive/anti-HCV negative). Such donors identified in Poland since 2000 when the NAT for HCV was introduced are very important for molecular epidemiology analysis. The increasing frequency of 3a and 4 genotypes is observed in comparison to blood donors and patients with anti-HCV antibodies.