Abstract
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.
Highlights
Poland was one of the first countries to introduce nucleic acid amplification testing (NAT) for blood donor screening
126 seronegative hepatitis C virus (HCV) RNA positive donations were detected in the years 2000 to 2016 (7.2/1 mln donations; 95% confidence intervals (95% CI), 5.9‐8.5): 50 donations were identified with Cobas Amplicor HCV v 2.0 (Roche), 14 with Cobas AmpliScreen HCV v 2.0 (Roche), 25 with CobasTaqscreen MPX (Roche), 14 with Cobas Taqscreen MPX 2.0 (Roche), 3 with Procleix HCV/HIV‐1 (Gen‐Probe), 11 with Procleix Ultrio (Gen‐Probe), 8 with Procleix Ultrio Plus (Gen‐Probe), and 1 with Procleix Utrio Ellite (Gen‐Probe)
During 17 years (2000‐2016) of HCV RNA screening in Polish blood donors, we prevented transfusion of blood components prepared from 126 donations collected at the seronegative, presumably early, stage of HCV infection
Summary
Poland was one of the first countries to introduce nucleic acid amplification testing (NAT) for blood donor screening. Molecular testing was implemented in 1999 for hepatitis C virus (HCV) RNA screening of plasma for fractionation and in 2002 for all blood donation.[1]. All donors in Poland are nonremunerated volunteers, who undergo medical assessment and have to deny risk factors for viral infections before donation, the number of serologic window‐period (WP) donations was found to be high. Busch and colleagues reported that since the implementation of HCV NAT screening through 2008, the highest number of HCV WP infections among participating European countries was noted in Poland, with 83 out of the total 123 infections.[2]. The HCV NAT‐only detection rate remains high in Poland with the residual risk of transfusion‐transmitted infection.[3,4]. The HCV NAT‐only detection rate remains high in Poland with the residual risk of transfusion‐transmitted infection.[3,4] One recently published study aiming to explain the high rate of HCV WP donations in Poland pointed to the likely impact of questionnaire design and donor compliance.[5]
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