The payment for whole blood donors provides a higher risk for infectious disease markers of first-time donations at the National Blood Center in Lithuania.
BACKGROUND
Hepatitis C virus (HCV) antigen and antibody combination assays have been launched as a cost-effective alternative to nucleic acid testing (NAT) for reducing the antibody-negative window period (WP). Later, a HCV antigen chemiluminescence immunoassay (CLIA) became available.
STUDY DESIGN AND METHODS
A panel composed of 337 HCV NAT–yield samples that were characterized for viral load (VL) and genotype was used to compare the sensitivity of two combination enzyme-linked immunosorbent assays (Monolisa, Bio-Rad; and Murex, formerly Abbott) and a HCV antigen CLIA (Abbott). Analytic sensitivity was compared with HCV RNA detection using Ultrio (Grifols) by testing serial dilutions of 10 genotype (gt)1 to gt4 samples.
RESULTS
HCV antigen CLIA detected 92.4% of samples, whereas Monolisa and Murex detected 38.3 and 47.5%, respectively. In the HCV RNA VL range of 105 to 107 IU/mL, Monolisa and Murex detected 38% to 56% of gt1, 85% to 78% of gt2, and 21% to 37% of gt3. The overall geometric mean 50% limit of detection (range) of Ultrio on gt1 to gt4 dilution series was 3.5 (1.2–7.7) copies/mL, compared to 3.3 × 106 (4.4 × 105-2.7 × 107), 3.4 × 106 (2.2 × 105–4.2 × 107), and 2728 (415–7243) copies/mL for Monolisa, Murex, and HCV antigen CLIA, respectively.
CONCLUSION
Analytical sensitivity of NAT was on average 1 million- and 780-fold higher than combination assays and HCV antigen CLIA, respectively. Relative sensitivities of combination assays differed for genotypes with Murex being more sensitive for gt1 and gt3 and Monolisa more sensitive for gt2. Although being less sensitive than NAT, combination assays could be considered in resource-limited settings since they detect 38% to 47% of seronegative WP donations.
HFE-hemochromatosis is a common autosomal recessive disease caused by HFE gene mutations and characterized as iron overload and failure of different organs. The aim of this study was to determine the prevalence of C282Y (c.845 G>A), H63D (c.187 C>G), and S65C (c.193A>T) alleles of HFE gene in the Lithuanian population. One thousand and eleven healthy blood donors of Lithuanian nationality were examined in four different ethnic Lithuanian regions to determine HFE gene alleles and genotype frequencies. The samples of DNA were analyzed for the presence of restriction fragment length polymorphism and validated by DNA sequencing. Among 1,011 blood donors tested, the frequency of C282Y, H63D, and S65C alleles were 2.6%, 15.9%, and 1.9%, respectively. One third of the tested subjects (n = 336) had at least one of the C282Y or H63D HFE gene mutations. The screening of Lithuanian blood donors has detected 13 (1.3%) subjects with a genotype C282Y/C282Y or C282Y/H63D responsible for the development of HFE-hemochromatosis. The prevalence of C282Y mutation was significantly higher among the inhabitants of Zemaitija (Somogitia) at the Baltic Sea area (5.9%) in comparison to the regions of continental part of Lithuania (2.4% in Dzukija, 2.3% in Aukstaitija, and 2% in Suvalkija, p < 0.05). These data support the hypothesis that the p.C282Y mutation originated from Scandinavia and spread with the Vikings along the Baltic Sea coast. The first epidemiological investigation of HFE gene mutations in ethnic Lithuanians showed that the frequencies of H63D, C282Y, and S65C of HFE gene alleles are similar to the other North-Eastern Europeans, especially in the Baltic region (Estonia, Latvia), Poland, and part of Russia (Moscow region).
Lithuania has a long history of remunerated donations. The first steps towards voluntary, non-remunerated blood and blood component donations started in 2004. Lithuania achieved 99.98% voluntary non-remunerated donations (VNRDs) in 2020. This study aimed to assess the risk of transfusion-transmitted infectious (TTI) disease markers for remunerated donations in comparison with VNRDs in Lithuania from 2013 to 2020. Data were obtained from the Lithuanian Blood Donor Register. The prevalence was calculated as the rate between the number of confirmed positive results for all TTI disease markers (serological anti-HCV, HBsAg, Ag/anti-HIV 1 and 2, and syphilis, and/or HCV, HBV, and HIV-1 NAT) per 100 donations. The relative risk of infectious disease markers for remunerated donations was then estimated. In total, 796310 donations were made. Altogether, 2743 donations were positive for TTI markers as follows: HCV, 1318; HBV, 768; syphilis, 583; and HIV 1 and 2, 74. The prevalence of confirmed TTI markers were 2.86, 0.97, 0.18, and 0.04 per 100 first-time remunerated donations, first-time VNRDs, repeat remunerated donations, and repeat VNRDs, respectively. Remunerated first-time and repeat donations had a statistically higher prevalence of TTI disease markers than VNRDs. First-time and repeat remunerated donations had statistically significantly higher relative risks of confirmed TTI disease markers than VNRD. In conclusion, the risks of TTI disease markers for remunerated first-time and repeat blood and its component donations are significantly higher than those for VNRDs.
We confirmed the association of the 9 loci (21q21.1, 1p36.13, NKX2-3, MST1, the HLA region, IL10, JAK2, ORMDL3, and IL23R) with UC in the Lithuanian-Latvian population. SNP-SNP interaction analyses showed that the combination of SNPs in the PTPN22 (rs2476601) and C13orf31 (rs3764147) genes increase the risk for UC.
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