Comparative evaluation of the Geenius HCV supplemental assay and Inno-LIA HCV score assay in detecting anti-HCV antibodies.

Objective: This study compared two assays aimed at confirming the presence of anti-HCV antibodies (Ab) after a positive screening: Geenius HCV supplemental assay (Bio-Rad, Marne la Coquette, France) and the Inno-LIA HCV score assay (Fujirebio, Les Ulis, France).

Material And Methods: A total of 180 archived samples were investigated including 119 samples collected at different stages of HCV infection in 25 hemodialyzed patients who underwent HCV seroconversion, 14 samples from 4 commercial seroconversion panels, 47 Ab positive/HCV-RNA positive blood donations of which 7 showing an single reactivity in confirmatory assays. Samples were investigated and results were interpreted with the two assays according to the manufacturers' instructions.

Residual risk of mother-to-child transmission of hepatitis B virus infection despite timely birth-dose vaccination in Cameroon (ANRS 12303): a single-centre, longitudinal observational study.

Background: In sub-Saharan Africa, administration of hepatitis B virus (HBV) birth-dose vaccines remains suboptimal. Evidence is scarce on whether African countries should focus on increasing vaccine coverage or developing strategies incorporating additional measures, such as peripartum antiviral prophylaxis to pregnant women at high risk. To better inform decision makers, we estimated the residual risk of mother-to-child transmission despite HBV birth-dose vaccine in Cameroon.

SARS-CoV-2 and post-donation information: a one-year experience of the French haemovigilance network.

Background: There is growing evidence to support the hypothesis that SARS-CoV-2 is probably not transmissible by blood transfusion. In this study, we use the data gathered over one year by the French haemovigilance network on post-donation information related to SARS-CoV-2, and virological investigations on corresponding plasma to explore viral transmission by transfusion.

Materials And Methods: Whenever a donor reported COVID-19 symptoms and/or a positive SARS-CoV-2 nasopharyngeal (NP) PCR test, information regarding diagnosis and symptoms was collected using a specific questionnaire, and repository plasmas were screened using the SARS-COV-2 R-GENE assay (Biomérieux).

Low rate of RNAemia in blood donations collected during the first wave of COVID-19 in France.

Background: To investigate the transmission of SARS-CoV-2 via blood, we conducted retrospective molecular screening in blood donated during the first pandemic peak in the two French regions with the highest community transmission.

Methods: Archived plasma samples randomly selected from donations collected between March 23 and 29, 2020, in Eastern and Northern regions of France were tested for SARS-CoV-2 RNA in minipools of 4 donations (MP4) using the Grifols ProcleixSARS-CoV-2 assay. Reactive MP4 and the four corresponding plasmas were further tested with alternative RT-PCRs and sequencing.

Accuracy assessment of total or IgG Immunoglobulin to hepatitis A virus tests around immunity threshold.

Background: Anti-hepatitis A virus (HAV) antibody titers at 20 IU/L are assumed to correlate with protection against HAV challenge.

Methods: We examined the accuracy and precision of currently in use immunoassays for total or anti-HAV IgG determination, by repeated testing of dilutions of the international anti-HAV standard, within a 10-50 IU/mL concentration range.

Results And Conclusion: Eight immunoassays were evaluated.

New insights into Human Pegivirus-1 (HPgV-1) genotypes diversity in sub-Saharan Africa.

In the framework of a viral discovery research program using metagenomics, Human Pegivirus-1 reads (HPgV-1, formerly known as GBV-C) were detected in plasma pools of healthy blood donors from seven sub-Saharan African countries. For five of these countries, Mauritania, Mali, Niger, Burundi and Madagascar, no data about HPgV-1 genotypes was reported to date. To confirm our metagenomic findings and further investigate the genotype diversity and distribution of HPgV-1 in Africa, 400 blood donations from these five localities as well as from Cameroon, the Democratic Republic of Congo (DRC) and the Burkina Faso were screened with a RT-nested PCR targeting the viral 5'NCR region.

Effectiveness of the HCV blood screening strategy through eighteen years of surveillance of HCV infection in blood donors in France.

Background: The question of maintaining blood screening based on both Hepatitis C virus (HCV) infection antibodies (Ab) and Nucleic Acid Testing (NAT) has been raised in several countries. The French blood donor surveillance database was used to address this issue.

Materials And Methods: In France, HCV-NAT was implemented in mini pools (MP) in 2001 and in individual testing (ID) in 2010.

Development and clinical validation of loop-mediated isothermal amplification (LAMP) assay to diagnose high HBV DNA levels in resource-limited settings.

Objective: A massive scale-up of testing and treatment is indicated to globally eliminate hepatitis B virus (HBV) infection. However, access to a polymerase chain reaction (PCR), a key test to quantify HBV DNA levels and determine treatment eligibility, is limited in resource-limited countries. We have developed and evaluated the loop-mediated isothermal amplification (LAMP) assay to diagnose clinically important HBV DNA thresholds defined by the WHO (≥20 000 and ≥ 200 000 IU/mL).

Challenges in transfusion-transmitted infection screening in Sub-Saharan Africa.

In Sub-Saharan Africa, high clinical demand for transfusion faces endemic bloodborne infections and limited resources. Blood screening for transfusion-transmitted bloodborne pathogens is the cornerstone of blood safety. Although there have been substantial improvements over the years, challenges in transfusion-transmitted infection screening that have been identified repeatedly long ago still need to be addressed.

No Evidence of Hepatitis C Virus (HCV)-Assisted Hepatitis D Virus Propagation in a Large Cohort of HCV-Positive Blood Donors.

A study reported in 2019 showed that hepatitis C virus (HCV) could help disseminate hepatitis D virus (HDV). To test this finding, 2123 plasma samples positive for anti-HCV antibody were screened for anti-HDV antibodies, and HDV-RNA was searched for in samples positive for anti-HDV antibody. Of 41 samples (1.

The evolving blood donor deferral policy for men who have sex with men: impact on the risk of HIV transmission by transfusion in France.

Background: Blood donation deferral for men who have sex with men (MSM) in France was reduced from permanent to 12 months in July 2016. To inform a further reduction of the deferral period, an HIV risk assessment was conducted with two scenarios: S1, 4-month deferral; S2, 4-month deferral only in the case of more than one sexual partner (i.e.

Impact on blood safety of the last arboviruses outbreaks in French Polynesia (2012-2018).

Background: Several successive arbovirus outbreaks have affected French Polynesia (FP) in the recent past years due to different dengue serotypes (DENV) present for several decades, Zika (ZIKV) (2013-2014) and chikungunya (CHIKV) (2014-2015) viruses with a potential impact on blood safety and blood supply due to the geographical isolation of these islands. This study reports an assessment of the impact of these outbreaks on blood products supply and infectious safety in FP and discuss the effectiveness of implemented preventive measures.

Methods: To ensure the infectious safety of blood products during outbreaks, several measures have successively been introduced as the selection of donors suspected of infection, the nucleic acid testing (NAT) and the pathogen reduction of platelets and plasmas.

Screening for Human Immunodeficiency Virus Infection by Use of a Fourth-Generation Antigen/Antibody Assay and Dried Blood Spots: In-Depth Analysis of Sensitivity and Performance Assessment in a Cross-Sectional Study.

We evaluated the performance of a fourth-generation antigen/antibody (Ag/Ab) assay for detecting HIV-1 infection on dried blood spots (DBS) both in a conventional laboratory environment and in an epidemiological survey corresponding to a real-life situation. Although a 2-log loss of sensitivity compared to that with plasma was observed when using DBS in an analytical analysis, the median delay of positivity between DBS and crude serum during the early phase postacute infection was 7 days. The performance of the fourth-generation assay on DBS was approximately similar to that of a third-generation (antibody only) assay using crude serum samples.

Human pegivirus-1 (HPgV-1) RNA prevalence and genotypes in volunteer blood donors from the Brazilian Amazon.

Objectives: The objectives of this study were to evaluate the prevalence of Human Pegivirus-1 (HPgV-1) viremia and genotype diversity among healthy blood donors from the Eastern Brazilian Amazon (city of Macapá, State of Amapá). There is little information for prevalence and circulation of HPgV-1 in this remote Brazilian region.

Materials And Methods: We conducted a study evaluating the HPgV-1 RNA prevalence and circulating genotypes in 431 volunteer blood donors originating from the Eastern Brazilian Amazon.

Parvovirus B19 seroprevalence, viral load, and genotype characterization in volunteer blood donors from southern Brazil.

Usually transmitted via respiratory droplets, parvovirus B19 (B19V) can also be acquired by blood transfusion especially because of viral persistence, resistance to blood treatment procedures, and high viral load during the early infection phase. This is particularly problematic in immunocompromised or anemic patients where the infection can have a severe outcome. As B19V DNA was detected in blood donations from South Brazil during a viral metagenomic survey performed by Next-Generation Sequencing, the objective of this retrospective study was to evaluate the seroprevalence, B19V DNA presence and circulating genotypes in a Hospital Blood Transfusion Service in Santa Maria city in South Brazil (Rio Grande do Sul state).

Transfusion of HIV-infected blood products despite highly sensitive nucleic acid testing.

Background: In France, the risk of HIV transmission by transfusion was reduced by implementing pooled nucleic acid testing (NAT) in 2001 and individual NAT in 2010. We report here the first case in France of transfusion of human immunodeficiency virus (HIV)-infected blood donated during HIV pre-ramp-up phase that tested individual NAT negative.

Methods: Blood donations are screened for HIV antibodies and HIV RNA (ProcleixUltrio, Grifols; limit of detection at 95%, 23 copies/mL).

High prevalence of cyclovirus Vietnam (CyCV-VN) in plasma samples from Madagascan healthy blood donors.

Cycloviruses, small ssDNA viruses belonging to the Circoviridae family, have been suggested as possible causes of enteric, respiratory and neurological disorders in human patients. One of these species, cyclovirus-Vietnam (CyCV-VN), initially isolated from cerebrospinal fluid samples of patients with unexplained neurological disorders, has since been reported in serum samples from chronically patients infected with HBV, HCV or HIV, in Italy. On the other hand, CyCV-VN was not detected in serum samples from healthy individuals.

Early MinION™ nanopore single-molecule sequencing technology enables the characterization of hepatitis B virus genetic complexity in clinical samples.

Until recently, the method of choice to characterize viral diversity consisted in cloning PCR amplicons of full-length viral genomes and Sanger-sequencing of multiple clones. However, this is extremely laborious, time-consuming, and low-throughput. Next generation short-read sequencing appears also limited by its inability to directly sequence full-length viral genomes.

Fifteen years of Nucleic Acid Testing in France: Results and lessons.

Of the 40 million donations screened with Nucleic acid testing (NAT) between July 2001 and December 2015 in France, 20 HIV-positive, 13 HCV-positive and 17 HBV (HBV-NAT was initiated in 2005 and extended to the whole country in 2010) donations were discarded thanks to NAT. The main benefit in terms of discarded donations is related to HBV with a yield of 0.88 per million donations, which is 12.

The potential of viral metagenomics in blood transfusion safety.

Thanks to the significant advent of high throughput sequencing in the last ten years, it is now possible via metagenomics to define the spectrum of the microbial sequences present in human blood samples. Therefore, metagenomics sequencing appears as a promising approach for the identification and global surveillance of new, emerging and/or unexpected viruses that could impair blood transfusion safety. However, despite considerable advantages compared to the traditional methods of pathogen identification, this non-targeted approach presents several drawbacks including a lack of sensitivity and sequence contaminant issues.

Occult hepatitis B infection and transfusion-transmission risk.

Advances in serology and viral nucleic acid testing (NAT) over the last decades significantly reduced the risk of transfusion-transmitted hepatitis B virus (HBV). The combination of HBsAg testing and NAT efficiently prevents the majority of HBV transmission. However, a specific residual risk remains associated with extremely low viral DNA levels in blood donors with occult HBV infection (OBI) that are intermittently or not detectable even by highly sensitive individual donation (ID) NAT.