Haemovigilance survey and screening strategy for arthropod-borne viruses in blood donors from Argentina.

Arthropod-borne viruses (arboviruses) count among emerging infections, which represent a major challenge for transfusion safety worldwide. To assess the risk of arboviruses-transmission by transfusion (ATT), we performed a survey to evaluate the potential threat for transfusion safety. Samples were retrospectively and randomly collected from donors who donated during the peak of dengue incidence in Cordoba (years: 2016 and 2019-2022). A cost-efficient strategy for molecular screening was implemented with a nucleic acid test (NAT) configured with Flavivirus and Alphavirus-universal degenerated primers targeting conserved gene regions. Besides, we evaluated the neutralizing antibody (NAb) prevalence by plaque reduction neutralization test (PRNT). A total of 1438 samples were collected. Among the NAT-screened samples, one resulted positive for Flavivirus detection. Subsequent sequencing of the PCR product revealed Saint Louis Encephalitis Virus (SLEV) infection (GeneBank accession number OR236721). NAb prevalence was 2.95% for anti-Dengue, 9.94% anti-SLEV, 1.09% anti-West Nile Virus, and 0% anti-Chikungunya. One of the NAb-positive samples also resulted positive for IgM against SLEV but negative by ARN detection. This is the first haemovigilance study developed in Argentina that evaluates the potential risk of ATT and the first research to determine the prevalence of NAb against Flavivirus through PNRT to avoid possible cross-reactions between Ab against Flavivirus. Herein, the finding of one SLEV-viremic donor and the detection of anti-SLEV IgM in a different donor demonstrated a potential threat for transfusion safety and emphasized the need for increased vigilance and proactive measures to ensure the safety of blood supplies.

Breakthrough infection by hepatitis B virus in a vaccinated blood donor: An emerging threat for transfusion safety in low-endemic countries?

We present the case of a breakthrough infection by hepatitis B virus (HBV), intending to warn about the challenge that HBV represents for transfusion safety. Virological markers for HBV infection were assayed during a blood donor screening by detection of HBsAg, anti-HBc, and viral nucleic acid (HBV DNA) by a nucleic acid test (NAT). Additionally, samples were analyzed for detection of immunoglobulin M anti-HBc, HBeAg, anti-HBe, and anti-HBs. A first-time donor repeatedly tested positive for HBV DNA by NAT and nonreactive for HBV-serological markers of infection. He stated having completed the anti-HBV vaccination schedule; thus, study of anti-Hbs resulted in reactive at protective level (18 mIU/mL). The donor denied clinical symptoms of hepatitis and remained healthy during the follow-up period. 95 days postdonation, NAT was negative, seroconversion of anti-HBc ab was detected, and a significant increase in anti-HBs concentration was measured (>1000 mIU/mL). This is the first case of HBV-breakthrough infection reported in Argentina and to our knowledge, this potential threat to transfusion safety is novel in an HBV low-endemic region with high coverage of HBV vaccination. The occurrence of breakthrough infections challenges the current protocols for the identification of HBV-infected subjects, could be a source of silent HBV transmission.

A novel mitigation strategy for the prevention of transfusion-transmitted malaria.

BACKGROUND: Malaria is caused by protozoa of the genus Plasmodium and transmitted by Anopheles mosquitos. In the US, blood donors are assessed for malaria risk, including donor travel or previous residence in endemic areas and history of malaria by questionnaire and deferred for three months or three years, respectively. METHODS: The Procleix Plasmodium Assay is a qualitative nucleic acid test based on transcription-mediated amplification (TMA) for the detection of 18S ribosomal RNA of P. falciparum, P. ovale, P. vivax, P. malariae, and P. knowlesi for use on the Procleix Panther system. Analytical sensitivity was evaluated with in vitro transcripts and infected red blood cells. For clinical specificity, 12,800 individual donations and 283 pools of 16 samples from routine US donors were screened. Malaria risk was evaluated by testing 862 donors deferred for 3 years. Reactive results were confirmed with in-house real-time TMA assay and serology. RESULTS: Assay sensitivity was 8.47-11.89 RNA copies/mL and 2.10-6.82 infected red cells/mL. Specificity was 99.99% in 12,800 individual donations and 100% in 283 pools of 16. Of 862 tested deferred donor samples, one donor (0.12%) confirmed positive individually and in pools; he remained confirmed positive for 13 months. The infected donor was a prior resident of a malaria-endemic area in West Africa. CONCLUSIONS: The Procleix Plasmodium Assay showed high sensitivity and specificity and detected Plasmodium RNA in an asymptomatic presenting donor. This assay may prove helpful as a screening test versus the use of risk questions to reduce the number of donors deferred for malaria risk.

Syphilis seroprevalence and incidence in US blood donors from 2020 to 2022.

BACKGROUND: HIV, HBV, and HCV infections for ~60% of the US blood supply are monitored by TTIMS with syphilis added in 2020. STUDY DESIGN AND METHODS: Data were compiled from October 2020 to September 2022. Syphilis prevalence was estimated for allogeneic and directed donors who were consensus positive (CP) and the subset of those with confirmed-active infections (AI). Prevalence and incidence were stratified by demographics for two consecutive 1-year periods, starting October 1, 2020 and for both years combined. Incidence was estimated for repeat donors. Associations between syphilis positivity and other infections were evaluated. RESULTS: Among 14.75 million donations, syphilis prevalence was 28.4/100,000 donations and significantly higher during the second year compared to the first year. Overall, syphilis incidence for the two-year period was 10.8/100,000 person-years. The adjusted odds of a CP infection were 1.18 (95% CI: 1.11, 1.26) times higher in the second year compared to the first, and for AI, 1.22 (95% CI: 1.10, 1.35) times higher in year 2. Highest rates occurred among males, first-time, Black, and younger (ages 18-39) donors, and those in the South US Census region. Syphilis CP donors were 64 (95% CI: 46, 89) times more likely to be HIV CP, and AI donors 77 (95% CI: 52, 114) times more likely to be HIV CP than non-CP donors, when controlling for confounders. SUMMARY/CONCLUSIONS: Syphilis prevalence increased over the study period mirroring national trends reported by CDC and is significantly associated with HIV CP.

Results of clinical effectiveness of conventional versus Mirasol-treated Apheresis Platelets in Patients with Hypoproliferative Thrombocytopenia (MiPLATE) trial.

BACKGROUND: The Mirasol® Pathogen Reduction Technology System was developed to reduce transfusion-transmitted diseases in platelet (PLT) products. STUDY DESIGN AND METHODS: MiPLATE trial was a prospective, multicenter, controlled, randomized, non-inferiority (NI) study of the clinical effectiveness of conventional versus Mirasol-treated Apheresis PLTs in participants with hypoproliferative thrombocytopenia. The novel primary endpoint was days of ≥Grade 2 bleeding with an NI margin of 1.6. RESULTS: After 330 participants were randomized, a planned interim analysis of 297 participants (145 MIRASOL, 152 CONTROL) receiving ≥1 study transfusion found a 2.79-relative rate (RR) in the MIRASOL compared to the CONTROL in number of days with ≥Grade 2 bleeding (95% confidence interval [CI] 1.67-4.67). The proportion of subjects with ≥Grade 2 bleeding was 40.0% (n = 58) in MIRASOL and 30.3% (n = 46) in CONTROL (RR = 1.32, 95% CI 0.97-1.81, p = .08). Corrected count increments were lower (p < .01) and the number of PLT transfusion episodes per participant was higher (RR = 1.22, 95% CI 1.05-1.41) in MIRASOL. There was no difference in the days of PLT support (hazard ratio = 0.86, 95% CI 0.68-1.08) or total number of red blood cell transfusions (RR = 1.12, 95% CI 0.91-1.37) between MIRASOL versus CONTROL. Transfusion emergent adverse events were reported in 119 MIRASOL participants (84.4%) compared to 133 (82.6%) participants in CONTROL (p = NS). DISCUSSION: This study did not support that MIRASOL was non-inferior compared to conventional platelets using the novel endpoint number of days with ≥Grade 2 bleeding in MIRASOL when compared to CONTROL.

Implementation of sexual risk behavior donor screening in Canada.

BACKGROUND: The two Canadian blood suppliers, Canadian Blood Services and Héma-Québec, removed the time-based deferral for men who have sex with men and adopted criteria assessing sexual risk behaviors. We report the impact of these changes on the safety and adequacy of the Canadian blood supply. STUDY DESIGN AND METHODS: Since 2022, all donors are asked if (1) they have had a new partner and (2) more than one sexual partner in the last 3 months. Donors answering yes to either question are asked if they had anal sex in the last 3 months; if yes, they are deferred for 3 months. We followed HIV rates for the 18 months before and 14 (Héma-Québec) or 18 months (Canadian Blood Services) post-implementation and interviewed HIV-positive whole blood donors. We assessed the number and characteristics of whole blood donors answering yes to the two first questions with or without deferral. RESULTS: There were four HIV-positive donations out of 1,492,355 donations pre-implementation and four out of 1,447,772 post-implementation (0.27/100,000 vs. 0.28/100,000, p = 1.00). Post-implementation, one HIV-positive donor was non-compliant with multiple criteria, no risk factors were identified in the others. 3.2% of donors answered yes to questions (1) and/or (2); 0.17% were deferred for a new partner and/or more than one partner and anal sex. Deferral rates were highest in first time, younger donors, and similar in males and females. CONCLUSION: Implementation of sexual risk behavior donor screening resulted in unchanged HIV rates to date and a manageable deferral rate.

Seasonal increase in syphilis screening reactivity rates in whole blood donors, United States, 2011-2023.

BACKGROUND: In December 2021, the U.S. Food and Drug Administration published a letter to clinical laboratory staff and healthcare providers detailing a risk of false Rapid Plasma Reagin (RPR) when using the Bio-Rad Laboratories BioPlex 2200 Syphilis Total & RPR kit in people who had received COVID-19 vaccination; Treponema pallidum particle agglutination assays did not appear to be impacted by this issue. We evaluated reactivity rates of syphilis screening with negative confirmatory testing at our institution by year and seasonality. METHODS: We performed a retrospective study of routine syphilis testing of whole blood (WB) collections at an academic hospital-based donor center in the eastern United States. All WB donations from 2011 to 2023 which demonstrated reactive syphilis screening (Beckman Coulter PK TP Microhemagglutination) with negative confirmatory testing (CAPTIA Syphilis (T. pallidum)-G) were evaluated. Reactivity rates by year and season of donation were compared using unpaired t-tests. RESULTS: A total of 109 WB donations from 86 unique donors who donated from 2011 to 2023 screened reactive for syphilis with negative confirmatory testing. The unconfirmed syphilis reactivity rate increased from 2018 to 2023 (mean: 0.360%) compared to 2011-2017 (mean: 0.071%, p < .05). An autumnal peak in unconfirmed reactives was observed. CONCLUSION: The unconfirmed syphilis reactivity rate among WB donors at our institution increased markedly since 2017 compared to the 7 years prior and doubled from 2020 to 2021. No testing assay changes explain these results. The autumnal peak in unconfirmed reactives suggests a possible environmental trigger such as viral infection or vaccination.

Detection of Plasmodium spp. in asymptomatic blood donors by the new Brazilian NAT PLUS HIV/HBV/HCV/Malaria Bio-Manguinhos kit.

BACKGROUND: Transfusion-transmitted malaria (TTM) is a public health problem in endemic and nonendemic areas. The Brazilian Ministry of Health (MH) requested the development of a nucleic acid amplification test (NAT) for the detection of Plasmodium spp. in public blood centers to increase blood safety. STUDY DESIGN AND METHODS: The new Brazilian NAT kit named NAT PLUS HIV/HBV/HCV/Malaria Bio-Manguinhos was first implemented in HEMORIO, a public blood center in the city of Rio de Janeiro. Since October 1, 2022, this blood center has been testing all its blood donations for malaria in a pool of six plasma samples to detect Plasmodium spp. by real-time polymerase chain reaction (PCR). RESULTS: Since the implementation of the NAT PLUS platform until February 2023, HEMORIO has successfully received and tested 200,277 donations. The platform detected two asymptomatic donors in the city of Rio de Janeiro, which is a nonendemic region for malaria. Our analyses suggested a malaria from the Amazon region caused by Plasmodium vivax, in the first case, while an autochthonous transmission case by Plasmodium malariae was identified in the rural area of Rio de Janeiro state. DISCUSSION: The NAT PLUS platform detects Plasmodium spp. in plasma samples with sensitivity capable of detecting subpatent infections. This is the first time worldwide that a group developed and implemented molecular diagnosis for Plasmodium spp. to be used by public blood centers to avoid TTM.

Consideration for alpha-gal syndrome in two critically ill persons with group O blood who received group B plasma.

BACKGROUND: The U.S. Centers for Disease Control and Prevention (CDC) has reported increasing rates of alpha-gal syndrome, an allergic response after meat ingestion (AGS). AGS has been associated with prior exposure to tick bites or other biologics characterized by a life-threatening immunoglobulin E (IgE)-mediated hypersensitivity to galactose-alpha-1,3-galactose (alpha-gal) an oligosaccharide structurally similar to the group B antigen on red blood cells (RBC) found in most non-primate mammalian meat and products derived from these mammals. In 2023, Transfusion reported 3 group O recipients of group B plasma in the Washington, D.C. metropolitan area with no history of meat allergy who had anaphylactic transfusion reactions compatible with AGS. AIMS: We investigated allergic reactions in 2 additional patients who received ABO minor-incompatible blood products at 2 hospitals in the D.C. area during fall 2023. METHODS: For both patients, a medical chart review was performed and IgE levels to alpha-gal were measured. RESULTS: The first patient, a 64-year-old, O-positive patient status post heart transplant with no known allergies, was admitted with acute COVID-19 induced antibody-mediated transplant rejection and placed on extracorporeal membrane oxygenation (ECMO). While undergoing plasma exchange (PLEX) (50% albumin/50% fresh frozen plasma (FFP)), the patient tolerated 2 units of group O FFP and 1 unit of group A FFP before becoming hemodynamically unstable during transfusion of 1 unit of B-positive FFP. PLEX was stopped. The patient later died of sepsis from underlying causes. The second patient, a 57-year-old O-positive man with a history of melanoma and neuro fibromatosis type 1, was undergoing an abdominal resection including transfusion of 3 units of O-positive RBC when he suffered hypotension and ventricular tachycardia requiring intraoperative code after receiving 2 units of group B FFP. Hiveswere noted after resuscitation. The patient had a history of tick bites but no known allergies. He is alive 5 months after the possible allergic event. Both patients had full transfusion reaction evaluations and immunology testing results above the positive cutoff for anti-alpha-gal IgE. DISCUSSION AND CONCLUSION: Two patients with O-positive blood and no known allergies experience danaphyl axis after transfusion with group B FFP. The symptoms cannot definitively be imputed to an allergic transfusion reaction, but the presence of IgE against alpha-gal supports an association. Medicating patients with antihistamines and IV steroids pre-transfusion may prevent allergic reactions. Restricting group B plasma-containing products (plasma, platelets, cryoprecipitate) for patients who experience AGS-like symptoms may be considered.

Universal nucleic acid donor screening revealed epidemiological features of hepatitis E and prevented transfusion-transmitted infection in Japan.

BACKGROUND: More than 45 cases of transfusion-transmitted hepatitis E virus infection (TT-HEV) have been reported in Japan. Therefore, in 2020, universal individual donation nucleic acid amplification testing (ID-NAT) was implemented for HEV. STUDY DESIGN AND METHODS: We characterized HEV NAT-positive blood donors. The number of new HEV infections and the asymptomatic infection rate were estimated using the HEV NAT-positive rate. HEV RNA quantitation, phylogenetic analysis, and antibody tests were performed, and the residual risk of TT-HEV was assessed based on the lookback study results. RESULTS: A total of 5,075,100 blood donations were screened with ID-NAT during the first year of implementation, among which 2804 (0.055%; males: 0.060%, females: 0.043%) were NAT-positive with regional differences. Approximately 270,000 new HEV infection cases were estimated to occur annually in Japan, with an asymptomatic infection rate of 99.9%. The median HEV RNA concentration, excluding cases below the limit of quantification, was 205 IU/mL. Among the 1113 cases where the genotype could be determined, HEV-3 and HEV-4 accounted for 98.8% (1100) and 1.2% (13), respectively. The maximum duration of HEV viremia, including the pre- and post-ID-NAT window periods, was estimated to be 88.2 days. Within the 3 years since ID-NAT implementation, no confirmed cases of breakthrough TT-HEV were observed. DISCUSSION: Multiple indigenous HEV strains are prevalent in Japan, infecting a significant number of individuals. However, since the implementation of ID-NAT, TT-HEV has been prevented due to the test's high sensitivity.

Implementation of amotosalen plus ultraviolet A-mediated pathogen reduction for all platelet concentrates in France: Impact on the risk of transfusion-transmitted infections.

BACKGROUND AND OBJECTIVES: Pathogen reduction (PR) technology may reduce the risk of transfusion-transmitted infections (TTIs), notably transfusion-transmitted bacterial infection (TTBI) associated with platelet concentrates (PCs). PR (amotosalen/UVA treatment) was implemented for all PCs transfused in France in November 2017. No bacterial detection was in place beforehand. The study aimed to assess the impact of PR PC on TTI and TTBI near-miss occurrences. MATERIALS AND METHODS: TTI and TTBI near-miss occurrences were compared before and after 100% PR implementation. The study period ran from 2013 to 2022. Over 300,000 PCs were transfused yearly. RESULTS: No PC-related transmission of human immunodeficiency virus, hepatitis C virus, hepatitis B virus and human T-cell lymphotropic virus was reported throughout the study period. PC-mediated hepatitis E virus and hepatitis A virus infections occurred irrespective of PR implementation. Mean PC-mediated TTBI occurrence before PR-PC implementation was 3/year (SD: 1; n = 15; 1/92,687 PC between 2013 and 2016) with a fatal outcome in two patients. Since PR implementation, one TTBI has been reported (day 4 PC, Bacillus cereus) (1/1,645,295 PC between 2018 and 2022; p < 0.001). Two PR PC quarantined because of a negative swirling test harboured bacteria: a day 6 PC in 2021 (B. cereus and Staphylococcus epidermidis) and a day 7 PC in 2022 (Staphylococcus aureus). Five similar occurrences with untreated PC were reported between 2013 and 2020. CONCLUSION: Transfusion of 100% PR PC resulted in a steep reduction in TTBI occurrence. TTBI may, however, still occur. Pathogen-reduced PC-related TTI involving non-enveloped viruses occurs as well.

Managing the risk of transfusion-transmitted malaria from Australian blood donations: Recommendation of a new screening strategy.

BACKGROUND AND OBJECTIVES: To reduce the risk of transfusion-transmitted malaria (TTM) from transfusible components, Australia tests for malaria antibodies in both travellers returning from and former residents of malaria-endemic areas. The testing is performed a minimum of 120 days after last potential exposure. TTM is an extremely rare event and managing the risk adds considerable complexity. The objectives of this study were to analyse various testing and deferral strategies, considering the risk, donation numbers and operational complexities. MATERIALS AND METHODS: A residual risk model was developed to calculate the risk of TTM in five testing/deferral strategies. Australian blood donor data from 2020 and 2021 were used and incorporated the incidence of parasitaemia, Plasmodium species and the malaria enzyme immunoassay test's failure rate. Donor and donation loss or gain and an operational assessment were performed. RESULTS: The current model's estimated risk of TTM is 1 in 67.9 million transfused units. Testing residents with a 120-day plasma restriction for visitors without testing was found to have the same estimated risk, with an expected increase of 342 donations per year, significant cost savings and a 62% reduction in the number of donors requiring assessment. CONCLUSION: A strategy that involves testing residents of malaria areas only and a 120-day plasma travel restriction would not significantly increase the risk of TTM, is operationally simpler, costs less and results in a small increase in donations.

Notification and follow-up of blood donors reactive for transfusion-transmitted infections: A narrative review of the literature from India.

BACKGROUND AND OBJECTIVES: Notifying blood donors of their reactive status for transfusion-transmitted infections (TTIs) plays a vital role in enabling early diagnosis and management while also preventing these donors from making future donation and transmission of the infectious agent. Given the limited data on donor notification processes in India, a narrative review was conducted to assess the existing notification process and identify areas requiring enhancement. MATERIALS AND METHODS: We conducted literature searches using PubMed, Google Scholar and Scopus, employing various keywords. The review included data on the year of the study, study design, donor numbers, TTI screening methods, sero-reactive donor confirmation, notification frequency and methods, donor responses, post-test counselling and risk factor assessment. RESULTS: Out of the 29 identified articles, 16 studies were included in the analysis. Repeat testing for initially reactive results was conducted in nine studies for 24.3% reactive donors. Phone calls were the primary notification method in most studies (8; 50%), with letters sent in cases of no response. Only 12 studies provided data on notified donors, revealing a notification rate of 71.2%. Of all initially reactive donors, 33.3% sought post-test counselling. Data from six studies indicated that 74.3% of responsive donors had identifiable TTI risk factors. CONCLUSION: Our review revealed significant variability in the notification processes across different studies. To enhance the management of TTI-reactive donor notifications and responses, we recommend the establishment of universal protocols encompassing pre-donation counselling, repeat/confirmatory testing, notification methods and comprehensive follow-up and treatment.

Dose-dependent inactivation of Plasmodium falciparum in red blood cell concentrates by treatment with short-wavelength ultraviolet light.

BACKGROUND AND OBJECTIVES: Plasmodium species are naturally transmitted by Anopheles mosquitos. The parasite infects red blood cells (RBCs) and can be transfused with blood products. In non-endemic areas, the main risk of infection arises from travellers coming back and people immigrating from malaria-endemic regions. Endemic countries face a permanent risk of infection from transfusion-transmitted malaria (TTM). TTM may cause life-threatening complications in patients dependent on blood donations. This study aimed to investigate the efficacy of Plasmodium falciparum inactivation in RBC units by treatment with short-wavelength ultraviolet C (UVC) light in the absence of photochemical additives. MATERIALS AND METHODS: RBC units were spiked with P. falciparum to a parasite density of 0.1%-1% and irradiated with up to 4.5 J/cm2 UVC. The parasite density of UVC-treated dilution series and untreated controls were compared over 3 weeks after irradiation. RESULTS: The lowest dose of 1.5 J/cm2 UVC led to a 3.1 log reduction in parasite load compared with the untreated control. The inactivation capacity was dose-dependent. Strikingly, 4.5 J/cm2 led to ≥5.3 log unit reduction, which was equivalent to a complete inactivation in two out of three experiments. CONCLUSION: Pathogen reduction with UVC light was previously shown to be effective for different bacteria and viruses, but the inactivation of parasites in RBC concentrates was not addressed until now. The present study provides evidence for significant inactivation of P. falciparum-infected RBCs by UVC light.

Deferral of blood donors who have ever stayed in a Trypanosoma cruzi endemic area: An international survey.

BACKGROUND AND OBJECTIVES: Trypanosoma cruzi is the etiologic agent of Chagas disease (CD), an anthropozoonosis from the American continent that progresses from an acute phase to an indeterminate phase, followed by a chronic symptomatic phase in around 30% of patients. In countries where T. cruzi is not endemic, many blood transfusion services test blood donors who have stayed in an endemic country ('at-risk stay')-even if they do not present with other risk factors. However, the efficiency of this approach has been questioned. MATERIALS AND METHODS: On 18 September 2023, a worldwide survey was distributed among employees of blood transfusion services. The questions mainly pertained to CD's endemicity in the blood services' region, the current testing policy for T. cruzi and the number of confirmed positive results among donors with a prior at-risk stay alone (i.e., without other risk factors for T. cruzi infection). RESULTS: Twenty-six recipients completed the survey. Of the 22 (84.6%) blood services that operated in a non-endemic region, 9 (42.9%) tested donors for T. cruzi, including 8 (88.9%) that considered the travel history or the duration of the stay (alone) in their testing algorithm ('study blood services'). Over 93 years of observation among all study blood services, 2 donations from donors with an at-risk stay alone and 299 from those with other risk factors were confirmed positive for T. cruzi. CONCLUSION: The study findings question the utility of testing blood donors who have stayed in an endemic country without other risk factors.

Seroreactivity of antibodies to hepatitis B core antigen among hepatitis B surface antigen-screened negative blood donors and its implications for blood safety in a resource-constrained country.

BACKGROUND AND OBJECTIVES: Transfusion-related hepatitis B infections have been reduced significantly with the implementation of blood screening using both serology and nucleic acid amplification technology (NAT) in developed countries. However, in resource-constrained countries, where NAT is inaccessible, the risk persists from early acute and occult cases. This study aimed to determine the antibodies to hepatitis B core antigen (anti-HBc) reactive rate among hepatitis B surface antigen (HBsAg)-screened negative blood donors and its impact on blood safety in the Philippines. MATERIALS AND METHODS: A total of 1602 HBsAg-negative samples, randomly collected from nine leading blood service facilities representative of each region in the Philippines, were tested for anti-HBc immunoglobulin M (IgM), Total and antibodies to HBsAg (anti-HBs) using the Architect i2000SR Immunoassay Analyser (Abbott Laboratories, IL). Anti-HBc IgM and/or Total repeat reactive were further tested for hepatitis B virus (HBV) NAT using the Cobas TaqScreen MPX v2.0 (Roche Diagnostics, Basel). RESULTS: Overall, 19.16% HBsAg-negative samples (n = 307/1602) were reactive for either anti-HBc IgM or Total or a combination of both, of which 1.3% (n = 4/307) had detectable HBV-DNA and 80.5% (n = 247/307) were anti-HBs positive. About the anti-HBs titres, 30.27% (n = 485/1602) were positive (≥10 IU/L) with 55.67% (n = 270/485) having titres ≥100 IU/L. Anti-HBs-only-positive samples were 14.85% (n = 238/1602). CONCLUSION: We observed a high anti-HBc reactive rate (19.16%) with 3.7% anti-HBc-only reactive (anti-HBs negative) and 1.3% HBV-DNA positive. This warrants the need to reconsider existing screening practices to improve blood safety in the country.

Impact of blood donation biovigilance and transfusion-transmitted infections on organ transplantation.

Over 118 million blood donations are collected globally each year. Recipients of blood products include those who experience major trauma or surgery, have acute blood loss and anemia, or impaired bone marrow function. Solid organ transplant recipients often require transfusion of blood products which places them at risk of transfusion-associated adverse events including transfusion-transmitted infection. National hemovigilance networks have documented low rates of transfusion-transmitted infection in the general population. Incidence transfusion-transmitted infection continues to occur in solid organ transplant patients and arises mainly from existing gaps in blood donor biovigilance processes. Emerging infectious diseases have highlighted existing gaps in the donor-recipient pathway to administering safe blood products. This article reviews the current process and regulatory oversight of blood donor biovigilance, including donor screening and microbiological testing, highlights cases of transfusion-transmitted infection documented in the literature, and addresses ways in which biovigilance may be improved, with a focus on the impact of solid organ transplantation.

Insight into hazards and control of transfusion-transmitted infections in Egypt: A narrative review.

Blood transfusion is a critical life-saving medical intervention, but it carries the risk of transfusion-transmitted infections (TTIs) that can lead to serious consequences. TTIs include viral, bacterial, parasitic, and prion infections, transmitted through asymptomatic donor blood, contamination of stored blood products, or transfusion-related immunosuppression. Recognized global agents posing challenges to blood safety include human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), Syphilis, etc. Emerging pathogens like SARS-CoV-2, hepatitis E, and others present additional risks. The residual risk of TTIs, representing the likelihood of infected donations passing screening tests, varies globally. High-income countries generally show lower prevalence rates than low-income countries. In Egypt, the estimated prevalence rates for HIV, HBV, HCV, and syphilis markers among the donors are 0.23 %, 0.76 %, 2.33 %, and 0.24 %, respectively. In Egypt, specific residual risk estimates are scarce, but prevalence rates for key infections highlight existing challenges. The World Health Organization promotes a global blood safety strategy, advocating for national blood systems, voluntary non-remunerated donors, and quality-assured testing. Despite these measures, the establishment of a haemovigilance system which is critical for monitoring and preventing adverse events, including TTIs, is reported as lacking in Egypt. This highlights the importance of comprehensive surveillance and safety measures in the blood donation process to ensure universal access to safe blood. Primary health care can play a pivotal role in preventing TTIs.

New threats from an old foe: Evaluating the risk to the blood supply due to increasing incidence and endemicity of leprosy in the United States.

Leprosy (i.e., Hansen's disease) is a chronic disease secondary to infection with either Mycobacterium leprae or M. lepromatosis. While the incidence of this disease is decreasing across the world, there is mounting evidence that it might be increasing, and becoming endemic, in the United States. Leprosy was once considered a potential threat to the blood supply, and while this threat has not borne out, it is worth revisiting the available data to assess whether it may pose a threat in the future. Herein, we discuss the evidence for and against the potential for transfusion-transmission of leprosy, and highlight future areas of research to further elucidate this possibility.

Transfusion-Transmitted Cache Valley Virus Infection in a Kidney Transplant Recipient With Meningoencephalitis.

BACKGROUND: Cache Valley virus (CVV) is a mosquito-borne virus that is a rare cause of disease in humans. In the fall of 2020, a patient developed encephalitis 6 weeks following kidney transplantation and receipt of multiple blood transfusions. METHODS: After ruling out more common etiologies, metagenomic next-generation sequencing (mNGS) of cerebrospinal fluid (CSF) was performed. We reviewed the medical histories of the index kidney recipient, organ donor, and recipients of other organs from the same donor and conducted a blood traceback investigation to evaluate blood transfusion as a possible source of infection in the kidney recipient. We tested patient specimens using reverse-transcription polymerase chain reaction (RT-PCR), the plaque reduction neutralization test, cell culture, and whole-genome sequencing. RESULTS: CVV was detected in CSF from the index patient by mNGS, and this result was confirmed by RT-PCR, viral culture, and additional whole-genome sequencing. The organ donor and other organ recipients had no evidence of infection with CVV by molecular or serologic testing. Neutralizing antibodies against CVV were detected in serum from a donor of red blood cells received by the index patient immediately prior to transplant. CVV neutralizing antibodies were also detected in serum from a patient who received the co-component plasma from the same blood donation. CONCLUSIONS: Our investigation demonstrates probable CVV transmission through blood transfusion. Clinicians should consider arboviral infections in unexplained meningoencephalitis after blood transfusion or organ transplantation. The use of mNGS might facilitate detection of rare, unexpected infections, particularly in immunocompromised patients.