An international review of the characteristics of viral nucleic acid-amplification testing (NAT) reveals a trend towards the use of smaller pool sizes and individual donation NAT.

BACKGROUND AND OBJECTIVES: Nucleic acid-amplification testing (NAT) is used for screening blood donations/donors for blood-borne viruses. We reviewed global viral NAT characteristics and NAT-yield confirmatory testing used by blood operators. MATERIALS AND METHODS: NAT characteristics and NAT-yield confirmatory testing used during 2019 was surveyed internationally by the International Society of Blood Transfusion Working Party Transfusion-Transmitted Infectious Diseases. Reported characteristics are presented herein. RESULTS: NAT was mainly performed under government mandate. Human immunodeficiency virus (HIV), hepatitis C virus (HCV) and hepatitis B virus (HBV) NAT was performed on all donors and donation types, while selective testing was reported for West Nile virus, hepatitis E virus (HEV), and Zika virus. Individual donation NAT was used for HIV, HCV and HBV by ~50% of responders, while HEV was screened in mini-pools by 83% of responders performing HEV NAT. Confirmatory testing for NAT-yield samples was generally performed by NAT on a sample from the same donation or by NAT and serology on samples from the same donation and a follow-up sample. CONCLUSION: In the last decade, there has been a trend towards use of smaller pool sizes or individual donation NAT. We captured characteristics of NAT internationally in 2019 and provide insights into confirmatory testing approaches used for NAT-yields, potentially benefitting blood operators seeking to implement NAT.

International review of blood donation nucleic acid amplification testing.

BACKGROUND AND OBJECTIVES: Nucleic acid amplification testing (NAT), in blood services context, is used for the detection of viral and parasite nucleic acids to reduce transfusion-transmitted infections. This project reviewed NAT for screening blood donations globally. MATERIALS AND METHODS: A survey on NAT usage, developed by the International Society of Blood Transfusion Working Party on Transfusion-transmitted Infectious Diseases (ISBT WP-TTID), was distributed through ISBT WP-TTID members. Data were analysed using descriptive statistics. RESULTS: Forty-three responses were received from 32 countries. Increased adoption of blood donation viral screening by NAT was observed over the past decade. NAT-positive donations were detected for all viruses tested in 2019 (proportion of donations positive by NAT were 0.0099% for human immunodeficiency virus [HIV], 0.0063% for hepatitis C virus [HCV], 0.0247% for hepatitis B virus [HBV], 0.0323% for hepatitis E virus [HEV], 0.0014% for West Nile virus [WNV] and 0.00005% for Zika virus [ZIKV]). Globally, over 3100 NAT-positive donations were identified as NAT yield or solely by NAT in 2019 and over 22,000 since the introduction of NAT, with HBV accounting for over half. NAT-positivity rate was higher in first-time donors for all viruses tested except WNV. During 2019, a small number of participants performed NAT for parasites (Trypanosoma cruzi, Babesia spp., Plasmodium spp.). CONCLUSION: This survey captures current use of blood donation NAT globally. There has been increased NAT usage over the last decade. It is clear that NAT contributes to improving blood transfusion safety globally; however, there is a need to overcome economic barriers for regions/countries not performing NAT.

The changing profile of SARS-CoV-2 serology in Irish blood donors.

Background: The present study aimed to investigate the progression of the SARS-CoV-2 pandemic in Ireland over the first three waves of infection. Method: A selection of blood donor serum samples collected between February 2020 and December 2021 were analysed by various commercially available serological assays for antibodies to SARS-CoV-2 (n = 15,066). Results: An increase in seropositivity was observed between wave 1 (February to September 2020) and wave 2 (November and December 2020) of 2.20% to 3.55%. A large increase in estimated seroprevalence to 11.89% was observed in samples collected in February and March 2021 (wave 3 of infection).The rate of seropositivity varied by age group, with the highest rate observed in the youngest donors (18-29 years) peaking at 18.79% in wave 3. The results of spike antibody (anti-S) testing indicated that 44/1009 (4.36%) of seroreactive donors in wave 3 had a serological profile consistent with vaccination. By November 2021, we detected an overall seropositivity of 97.04%. Conclusions: The present study provides a comprehensive estimation of the level of circulating SARS-CoV-2 antibodies in Irish blood donors, enabling differentiation between vaccination and natural infection, as well as real-time monitoring of the progression of the COVID-19 pandemic in Ireland. Seroepidemiology has a role in determining reliable estimates of transmission, infection fatality rates and vaccine uptake. The continued screening of blood donors for this purpose has the potential to generate important data to assist with the management of future waves of SARS-CoV-2.

Human T-lymphotropic virus in Irish blood donors: Impact on future testing strategy.

AIM: A risk-based approach to the testing of blood donations for Human T-Lymphotropic Virus (HTLV) should include an assessment of blood donation seroepidemiology. The objectives of the present study were to determine the proportion of HTLV positive units in Irish blood donations, and subsequently, to estimate the current risk of transfusion transmitted HTLV (TT-HTLV). METHODS: Over 3 million donations screened between 1996 and 2020, were included in the study (n = 3,666,253). Factors considered in the assessment of TT-HTLV risk included: (I) HTLV seropositivity, (ii) probability of a leucodepletion failure, and (iii) the HTLV testing strategy. RESULTS: Six HTLV positive donations were detected throughout the study period, all of them in previously unscreened blood donors (0.000164%; n = 6/3,666,253), 3 of whom had donated prior to the introduction of HLTV antibody testing. On average 0.11% of manufactured blood components assessed, failed to satisfy the leucodepletion quality assurance criteria of less than 1 × 106 cells/unit. In using these values to model the risk of TT-HTLV, it was shown that the combination of leucodepletion with either universal screening of all = donors, or selective testing of first-time donors, a possible HTLV transfusion transmitted infection would be prevented every 468-3776 years. CONCLUSIONS: This is the first report on the proportion of HTLV positive in Irish blood donations (1996-2020) and will be used to inform blood donation screening policy in Ireland. Evidence is provided for recommending a selective HTLV donor screening algorithm in Ireland that is accompanied by a robust framework for continued surveillance of leucodepletion failure rate.

Confirmed circulation of SARS-CoV-2 in Irish blood donors prior to first national notification of infection.

INTRODUCTION: Blood donor studies offer a unique opportunity to screen healthy populations for the presence of antibodies to emerging infections. We describe the use of blood donor specimens to track the 'first-wave' of the COVID-19 pandemic in Ireland. METHODOLOGY: A random selection of donor samples received by the Irish Blood Transfusion Service (IBTS) between February and September 2020 (n = 8,509) were screened by multiple commercial SARs-CoV-2 antibody assays. The antibody detection rate was adjusted to the population to determine the SARS-CoV-2 seroprevalence in Ireland. RESULTS: SARS-CoV-2 antibody detection rose significantly during the first peak of COVID-19 infection, increasing from 0.3% in March, to 2.9% in April (p < 0.0001, The first SARS-CoV-2 antibody positive donor samples were collected on the 17th February 2020, 2 weeks prior to the first official notification. This is the earliest serological evidence of SARS-CoV-2 circulating in the Irish population. Our results also show a significantly higher antibody prevalence in the Capital city and in donors less than 40 years of age. CONCLUSIONS: The present study demonstrates evidence of SARS-CoV-2 antibody reactivity across all age groups and counties. The critical value of blood donor seroprevalence studies is apparent in this report which identified the earliest serological evidence of SARS-CoV-2 infection in Ireland, as well as documenting the evolution of COVID-19 pandemic in Ireland over time.

Hepatitis E virus infection in the Irish blood donor population.

BACKGROUND: Hepatitis E virus (HEV) Genotype 3 (G3) infection is a zoonosis that may be transmitted during the acute phase by transfusion. The aim of this study was to determine the incidence of HEV and seroprevalence among Irish blood donors. STUDY DESIGN AND METHODS: Anonymized samples from 1076 donations collected in 2012 were tested for HEV immunoglobulin (Ig)G using the Wantai enzyme-linked immunosorbent assay. A total of 24,985 anonymized donations collected between December 2013 and June 2014 were individually tested for HEV RNA using the Procleix HEV assay; reactive donations were confirmed by an in-house real-time polymerase chain reaction (PCR) test. RESULTS: Seroprevalence for anti-IgG was 5.3% (95% confidence interval [CI], 4.0%-6.8%), ranging from 1.1% in the 18- to 29-years age group to 33.3% in males over 60 years. HEV RNA screening of 24,985 samples yielded five PCR-confirmed donations (1:4997, 0.02%; 95% CI, 0.0065%-0.0467%), only one of which was serologically reactive (HEV IgM reactive only). Viral loads ranged from 10 to 44,550 IU/mL. Genotype analysis on three samples identified HEV G3 virus. Four of the five viremic donations were from donors in the 18- to 29-years age group (p = 0.01). CONCLUSION: Seroprevalence for anti-HEV IgG was low compared to some European countries, but 1 in 5000 donations was viremic. Viremia was predominantly in younger Irish donors. After Department of Health approval the Irish Blood Transfusion Service implemented individual blood donation HEV RNA screening initially for a 3-year period from January 2016.