Comparison of hepatitis E virus nucleic acid test screening platforms and RNA prevalence in French blood donors

Gallian, Pierre; Couchouron, Anne; Dupont, Isabelle; Fabra, Cécile; Piquet, Y.; Djoudi, Rachid; Assal, Azzedine; Tiberghien, Pierre

doi:10.1111/trf.13889

Cited by 32 publications

(26 citation statements)

References 6 publications

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“…Samples can be screened in MP or ID format. The most commonly used assays in blood screening are the Procleix HEV assay (95% LoD 7.89 IU/mL; Panther testing system; Grifols Diagnostic Solutions, Inc., developed in collaboration with Hologic, Inc.) [previously described 11, 15] and the Cobas HEV PCR assay (95% LoD 18.6 IU/mL; Cobas 6800/8800 systems; Roche Molecular Systems, Inc.) [28]. The RealStar HEV RT-PCR kit® for donation screening (95% LoD 4.7 IU/mL; Altona Diagnostics, Hamburg, Germany) is also used by some blood establishments [32].…”

Section: Overview Of Eu Blood Donor Screening Methods and Strategiesmentioning

confidence: 99%

“…A number of HEV screening strategies have been employed between 2012 and 2015, including ID-NAT, MP-6, and MP-96, yielding an overall reactivity rate of 1: 1,616 donations (Table 3). MP-96 screening (2012; RealStar RT-PCR kit, Altona; 1: 2,218) was reduced to MP-6 in 2014 (RealStar RT-PCR kit, Altona; 1: 1,317) [28]. Since January 2018, selective MP-6 screening is performed using the Procleix HEV assay [Gallian P., pers.…”

Section: Overview Of Eu Blood Donor Screening Methods and Strategiesmentioning

confidence: 99%

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Blood Donor Screening for Hepatitis E Virus in the European Union

Boland

Martinez

Pomeroy

et al. 2019

Transfus Med Hemother

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This review article summarises hepatitis E virus (HEV) blood donation screening strategies in effect in the European Union (EU). Since 2012, eight EU countries have implemented HEV screening. Local rates of seroprevalence, RNA incidence, and molecular epidemiology are variable and not usually directly comparable. We report a range of HEV-RNA reactivity rates from 1 in 744 donations (France) to 1 in 8,636 donations (Wales) with an overall EU rate of 1 in 3,109 donations (3.2 million donations screened). HEV genotypes 3c, 3e, and 3f are the most frequently reported subtypes. In these 8 countries, both universal (n = 5) and selective (n = 3) screening policies have been introduced utilising either individual donation (ID; n = 1) or mini-pool (MP; n = 7; MP-6, -16, -24, and -96) testing. We also describe the Irish experience of HEV screening utilising an ID-NAT-based donor screening algorithm which intercepts donations even from those with low-level viraemia; 21 of 56 donors (37.5%) had a viral load (VL) < 100 IU/mL. We performed a MP-24 experiment which may prove useful to colleagues in relation to donor screening and associated blood component transmissibility. Irish results indicate that 59% of donors with a HEV-VL < 450 IU/mL may have screened negative in a MP-24.

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Section: Overview Of Eu Blood Donor Screening Methods and Strategiesmentioning

confidence: 99%

Section: Overview Of Eu Blood Donor Screening Methods and Strategiesmentioning

confidence: 99%

Blood Donor Screening for Hepatitis E Virus in the European Union

Boland

Martinez

Pomeroy

et al. 2019

Transfus Med Hemother

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“…Blood safety is today on the highest safety level, especially for transfusion-transmitted virus infections such as HCV, HIV-1 and HBV due to the introduction of high-sensitive NAT and serological 4th-generation diagnostic systems [42][43][44][45]. New emerging pathogens such as hepatitis E virus, chikungunya virus and dengue virus are still relevant in some regional parts of the world and can be in principle also screened by NAT or serology [46][47][48]. Compared to this, high safety level bacterial contaminations are still a challenge in transfusion medicine and are different from virus infections.…”

Section: Discussionmentioning

confidence: 99%

New strategies for bacterial contaminations

Schmidt

Seifried

2016

ISBT Science Series

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Background The detection of bacterial contaminations in blood components can be classified in culture methods, rapid detection methods and experimental new technologies. Culture methods Culture methods have shown their benefit through easy handling and high analytic sensitivity. The challenge with culture methods, with the negative‐to‐date release concept, is a risk for false negative screening results due to sample failures and a reduced clinical efficiency. Rapid detection methods Within the last decade, rapid bacterial detection systems (RBDS) were developed as an alternative option to culture systems. In RBDS, testing time is reduced to 2–3 h. Therefore, a negative‐to‐date release concept is not necessary using these systems. New technologies In addition, new technologies are currently in development to detect bacterial strains in blood components. Electrochemical biosensors were developed for many different analytes, which range in size from individual ions and small molecules to nucleic acids and proteins up to whole viruses and bacteria. Conclusions Bacterial detection in blood components, especially in platelets, is implemented in many blood donor services. New approaches are promising to come to a next level to be implemented into routine screening, but the analytical sensitivity has to be improved for some of the new test systems in the coming years. Due to the fact that a risk for bacterial contamination still occurs in all blood components, the focus in transfusion medicine in the next decade will be the development of general principles and strategies to detect or inactivate bacteria in all blood components. Therefore, new developments are gladly welcome.

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“…Sixty‐two contaminated blood products were transfused, leading to HEV infection in recipients in 42% of cases . In France, the prevalence of positive HEV viraemia in blood donors is estimated to be 1/800 . A French study reported 23 cases of transfusion‐transmitted infections between 2006 and 2016, including 14 with chronic hepatitis in immunosuppressed patients …”

Section: Epidemiologymentioning

confidence: 99%

“…8 In France, the prevalence of positive HEV viraemia in blood donors is estimated to be 1/800. 9 A French study reported 23 cases of transfusion-transmitted infections between 2006 and 2016, including 14 with chronic hepatitis in immunosuppressed patients. 10 In the developed countries, acute hepatitis E usually affects middle aged and elderly men (sex ratio of 4/1, median age 55) often with excessive alcohol consumption.…”

Section: Epidemi Ologymentioning

confidence: 99%

Hepatitis E, what’s the real issue?

Larrue

Abravanel

Péron

2020

Liver International

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Hepatitis E Virus (HEV) infection is a worldwide disease and the primary cause of acute viral hepatitis in the world with an estimated 20 million cases every year and 70 000 deaths. Hepatitis E is a waterborne infection in the developing countries. In these countries, HEV genotypes 1 and 2 cause large outbreaks and affect young subjects, resulting in significant mortality in pregnant women and patients with cirrhosis. In the developed countries, HEV genotypes 3 and 4 are responsible for autochthonous, sporadic hepatitis and transmission is zoonotic. Parenteral transmission by the transfusion of blood products has been identified as a potential new mode of transmission. The prevalence of positive HEV viraemia in blood donors in Europe ranges from 1/600 to 1/2500 in highly endemic European countries. HEV can cause neurological disorders and chronic infections in immunocompromised patients. The progression of acute hepatitis E is usually asymptomatic and resolves spontaneously. Diagnostic tools include anti‐HEV IgM antibodies in serum and/or viral RNA detection in the blood or the stools by PCR. Ribavirin is used to treat chronic infection. A vaccine has been developed in China.

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Comparison of hepatitis E virus nucleic acid test screening platforms and RNA prevalence in French blood donors

Abstract: International audienc

Cited by 32 publications

References 6 publications

Blood Donor Screening for Hepatitis E Virus in the European Union

Blood Donor Screening for Hepatitis E Virus in the European Union

New strategies for bacterial contaminations

Hepatitis E, what’s the real issue?

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