Background rate of low‐level HCV RNA in anti‐HCV confirmed‐positive and minipool nucleic acid test‐nonreactive blood donations

Abstract

Background In 2019, the Food and Drug Administration revised the requirement for further testing of anti‐HCV‐reactive donations testing nucleic acid (NAT)‐nonreactive via routine mini‐pool (MP)‐NAT. Individual donation (ID)‐HCV NAT was required as a supplemental test prior to a second FDA‐licensed anti‐HCV assay; if ID‐HCV‐NAT is reactive, no further testing is required. This study investigated the rate of low‐level RNA in anti‐HCV‐reactive donation samples prior to and following the implementation of supplemental ID‐HCV NAT. Study Design/Methods A retrospective analysis was conducted on frozen plasma unit samples from 1161 anti‐HCV confirmed‐positive/HCV‐NAT‐nonreactive donations collected from December 2014 to January 2020. Samples were tested by multiple replicates on the Grifols Procleix Ultrio Elite (UE) assay and corresponding discriminatory HCV (dHCV) assay on the Procleix Panther System. Prospectively, the prevalence of low‐level RNA in 2912 anti‐HCV‐reactive donations detected through routine screening from April 2020 through March 2021 was determined. Results In retrospective analyses, 10 (0.86%) of 1161 plasma samples were UE reactive, of which four (0.34%) were dHCV reactive (in all replicates of UE and dHCV). Of 2912 anti‐HCV‐reactive donation samples testing NAT‐nonreactive via routine MP‐NAT, three (0.1%; 95% CI: 0.04‐0.30) were dHCV reactive; 37% of the remaining samples were reactive by a second anti‐HCV assay and thus serologically confirmed. Conclusions Retrospective and prospective analysis in comparison to earlier studies revealed that low‐level HCV‐RNA reactivity is decreasing over time. The very low HCV‐RNA rates may be due to the widespread use of highly effective, direct‐acting anti‐viral treatments for those diagnosed with HCV infection.

Second hepatitis C virus transmission by blood components since introduction of mandatoryNATscreening in Germany

“…12 Surveillance data from repeat donations for 2019 published by the Robert Koch-institute (RKI) and the look-back data from 2008-2015 reported to the Paul-Ehrlich-Institut (PEI) 8 justified due to the marginal effect on the RR of TT HCV infection compared to applied MP-NAT test strategies. 7,8,23 The outcome of the recent nationwide survey indicates that the implemented donor screening strategies are sufficient to ensure a high standard of blood safety in Germany. 8 Due to the high doubling-time of HCV in the early period of infection, most countries in the world with a low HCV prevalence, like Western Europe, have implemented HCV NAT based on the MP strategy.…”

“…Moreover, it is important to note that most blood donations in Germany (more than 70%) screen for HCV RNA by MP96‐NAT. Although ID‐NAT testing would have prevented the recent HCV transmission, its introduction does not seem to be justified due to the marginal effect on the RR of TT HCV infection compared to applied MP‐NAT test strategies 7,8,23 . The outcome of the recent nationwide survey indicates that the implemented donor screening strategies are sufficient to ensure a high standard of blood safety in Germany 8 .…”

Improved detection of hepatitis C virus‐positive blood donors and determination of infection status

“…Cappy et al 20 estimated that approximately 0.5% of HCV‐antibody positive but NAT negative blood donations in France had low HCV RNA levels. Groves et al 21 reported that low‐level HCV‐RNA reactivity is decreasing over time from 0.34% to 0.1%, perhaps due to the widespread use of highly effective direct‐acting antiviral treatments of HCV infection in USA.…”

Detection of Hbv Dna By Direct Pcr Protocol And Nested Pcr Protocol And Comparing Them. In Chronic Patients and Healthy Carriers of Hepatitis B Virus.

“…The chronic hepatitis B virus infection are also health problems in Iraq. The reported prevalence of hepatitis B rate is (2-4) % among normal Iraqi population which is among the countries of intermediate hepatitis B endemicity [7]. Countries with intermediate or high endemicity must have mass immunization for all infants at birth and for all risk groups [8].…”