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1.
JAMA Netw Open ; 4(10): e2128615, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1453504

ABSTRACT

Importance: The number of clinics marketing stem cell products for joint diseases, chronic pain, and most recently, COVID-19, has increased despite warnings from the US Food and Drug Administration that stem cell products for these and other indications have not been proven safe or effective. Objective: To examine bacterial infections in 20 patients who received umbilical cord blood-derived products marketed as stem cell treatment. Design, Setting, and Participants: This case series is a national public health investigation including case-finding, medical record review and abstraction, and laboratory investigation, including sterility testing of products and whole-genome sequencing of patient and product isolates. Participants included patients who developed bacterial infections following administration of umbilical cord blood-derived products marketed as stem cell treatment during August 2017 to September 2018. Data analysis was performed from March 2019 to September 2021. Exposures: Umbilical cord blood-derived products marketed as stem cell treatment. Main Outcomes and Measures: Data were collected on patient infections and exposures. The Centers for Disease Control and Prevention performed sterility testing on undistributed and distributed vials of product marketed as stem cell treatment and performed whole-genome sequencing to compare patient and product bacterial isolates. Results: Culture-confirmed bacterial infections were identified in 20 patients (median [range] age, 63 [2-89] years; 13 male patients [65%]) from 8 US states who sought stem cell treatment for conditions including pain, osteoarthritis, rheumatoid arthritis, and injury; all but 1 required hospitalization. The most frequently isolated bacteria from patients with infections were common enteric species, including Escherichia coli (14 patients) and Enterobacter cloacae (7 patients). Of unopened, undistributed products sampled for testing, 65% (22 of 34 vials) were contaminated with at least 1 of 16 bacterial species, mostly enteric. A patient isolate from Arizona matched isolates obtained from products administered to patients in Florida, and patient isolates from Texas matched undistributed product sent from the company in California. Conclusions and Relevance: Unapproved stem cell products can expose patients to serious risks without proven benefit. Sequencing results suggest a common source of extensive contamination, likely occurring during the processing of cord blood into product. Patients and health care practitioners who are considering the use of unapproved products marketed as stem cell treatment should be aware of their unproven benefits and potential risks, including serious infections.


Subject(s)
Bacterial Infections/etiology , Blood Safety/statistics & numerical data , Cord Blood Stem Cell Transplantation/adverse effects , Disease Outbreaks , Adolescent , Adult , Aged , Aged, 80 and over , Bacterial Infections/epidemiology , Bacterial Infections/prevention & control , Blood Safety/standards , Centers for Disease Control and Prevention, U.S. , Child , Child, Preschool , Cord Blood Stem Cell Transplantation/standards , Female , Humans , Male , Marketing , Middle Aged , Outcome Assessment, Health Care , Public Health Surveillance , United States/epidemiology , United States Food and Drug Administration , Young Adult
4.
Pharmaceut Med ; 35(5): 281-286, 2021 09.
Article in English | MEDLINE | ID: covidwho-1397080

ABSTRACT

Traditional approaches to blood regulation emphasise the precautionary principle and pursue zero-risk for viral transmission; these traditional approaches have usually followed tragedy, such as the HIV and hepatitis C infections that followed the use of factor VIII concentrates. However, a much more haphazard haemovigilance system operates for general adverse events. Such imprecise assessment of hazards prevents sound benefit-risk assessment, and for blood products this is further confounded by the fact that their efficacy has attracted little systematic study. The ongoing COVID-19 pandemic has now prompted the proposal of a convalescent plasma (CP) blood product. Clearly, mere freedom from infectious agents will not suffice in assessing CP, and an objective measure of efficacy, so as to permit formal benefit-risk analysis, is essential. This is both a scientific and an ethical demand, as has been the case for other experimental COVID-19 treatments. With special reference to COVID-19 CP, the well-recognized adverse events of transfusion-associated lung injury (TRALI) and transfusion-associated circulatory overload (TACO) will be important. Furthermore, not only efficacy but also product quality attributes (e.g., antibody titre) will have to be defined. Both of these are outside the traditional regulatory philosophy for blood products and are needed to truly assess the benefit-risk of this putative therapeutic product.


Subject(s)
Blood Safety , COVID-19/therapy , COVID-19/blood , COVID-19/immunology , COVID-19/virology , Humans , Immunization, Passive/adverse effects , Patient Safety , Risk Assessment , Risk Factors , Treatment Outcome
6.
Transfusion ; 60(6): 1119-1122, 2020 06.
Article in English | MEDLINE | ID: covidwho-1388414

ABSTRACT

Oral swabs, sputum, and blood samples from 18 asymptomatic and symptomatic patients with SARS-CoV-2 infection were examined using RT-PCR testing in order to assess the risk of transfusion-related transmission. In asymptomatic patients as well as patients with flu-like symptoms and fever, no SARS-CoV-2 RNA could be detected in the blood or serum despite a clearly positive result in all throat swabs. As patients with symptoms of infectious disease will not be admitted to blood donation, the risk for transfusion transmission of SARS-CoV-2 seems to be negligible.


Subject(s)
Asymptomatic Infections , Betacoronavirus/isolation & purification , Blood Donors , Blood Safety , Coronavirus Infections/transmission , Donor Selection , Pneumonia, Viral/transmission , Transfusion Reaction/prevention & control , Adolescent , Adult , Aged , COVID-19 , Coronavirus Infections/blood , Coronavirus Infections/diagnosis , Female , Germany , Humans , Male , Middle Aged , Pandemics , Pneumonia, Viral/blood , Pneumonia, Viral/diagnosis , SARS-CoV-2 , Transfusion Reaction/virology , Young Adult
7.
Transfusion ; 61 Suppl 2: S36-S43, 2021 09.
Article in English | MEDLINE | ID: covidwho-1358634

ABSTRACT

INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic has disrupted healthcare services worldwide. However, little has been reported regarding the impact on blood utilization. We quantified the impact of COVID-19 on blood utilization and discards among facilities reporting to the National Healthcare Safety Network Hemovigilance Module. METHODS: Facilities continuously reporting data, during January 2016-June 2020, on transfused and discarded blood components, stratified by component type (red blood cells [RBC], platelets, and plasma), were included. Interrupted time-series analysis with generalized estimating equations, adjusting for facility surgical volume and seasonality, was used to quantify changes in blood utilization and discards relative to a Centers for Medicare & Medicaid Services notification delaying nonessential medical procedures (March 2020). RESULTS: Seventy-two facilities included in the analyses, on average, transfused 44,548 and discarded 2,202 blood components monthly. Following the March 2020 notification and after multivariable adjustment, RBC and platelet utilization declined, -9.9% (p < .001) and -13.6% (p = .014), respectively. Discards increased for RBCs (30.2%, p = .047) and platelets (60.4%, p = .002). No statistically significant change in plasma was found. Following these abrupt changes, blood utilization and discards rebounded toward baseline with RBC utilization increasing by 5.7% (p < .001), and platelet and RBC discards decreasing -16.4% (<0.001) and -12.7 (p = .001), respectively. CONCLUSION: Following notification delaying elective surgical procedures, blood utilization declined substantially while blood discards increased, resulting in substantial wastage of blood products. Ongoing and future pandemic response efforts should consider the impact of interventions on blood supply and demand to ensure blood availability.


Subject(s)
Blood Safety , Blood Transfusion/statistics & numerical data , COVID-19/epidemiology , Blood Component Transfusion/statistics & numerical data , COVID-19/pathology , COVID-19/virology , Data Collection , Delivery of Health Care , Elective Surgical Procedures/statistics & numerical data , Facilities and Services Utilization/statistics & numerical data , Humans , Interrupted Time Series Analysis , Pandemics , SARS-CoV-2/isolation & purification , United States/epidemiology
8.
Transfus Apher Sci ; 60(4): 103207, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1336983

ABSTRACT

Blood transfusions come with risks and high costs, and should be utilized only when clinically indicated. Decisions to transfuse are however not always well informed, and lack of clinician knowledge and education on good clinical transfusion practices contribute to the inappropriate use of blood. Low and middle-income countries in particular take much strain in their efforts to address blood safety challenges, demand-supply imbalances, high blood costs as well as high disease burdens, all of which impact blood usage and blood collections. Patient blood management (PBM), which is a patient-focused approach aimed at improving patient outcomes by preemptively diagnosing and correcting anaemia and limiting blood loss by cell salvage, coagulation optimization and other measures, has become a major approach to addressing many of the challenges mentioned. The associated decrease in the use of blood and blood products may be perceived as being in competition with blood conservation measures, which is the more traditional, but primarily product-focused approach. In this article, we hope to convey the message that PBM and blood conservation should not be seen as competing concepts, but rather complimentary strategies with the common goal of improving patient care. This offers opportunity to improve the culture of transfusion practices with relief to blood establishments and clinical services, not only in South Africa and LMICs, but everywhere. With the COVID-19 pandemic impacting blood supplies worldwide, this is an ideal time to call for educational interventions and awareness as an active strategy to improve transfusion practices, immediately and beyond.


Subject(s)
Blood Banks/organization & administration , Blood Transfusion , Bloodless Medical and Surgical Procedures , Anemia/therapy , Blood Banks/economics , Blood Loss, Surgical , Blood Safety , Blood Transfusion/economics , Blood-Borne Infections/prevention & control , Bloodless Medical and Surgical Procedures/economics , COVID-19 , Clinical Decision-Making , Developing Countries , Donor Selection/economics , Evidence-Based Medicine , Female , HIV Infections/epidemiology , HIV Infections/prevention & control , Health Services Needs and Demand , Humans , Male , Pandemics , Postpartum Hemorrhage/therapy , Practice Guidelines as Topic , Pregnancy , Prevalence , Procedures and Techniques Utilization , SARS-CoV-2 , South Africa/epidemiology , Transfusion Medicine/education
10.
BMC Infect Dis ; 21(1): 357, 2021 Apr 16.
Article in English | MEDLINE | ID: covidwho-1315854

ABSTRACT

BACKGROUND: In 2020, a new coronavirus, SARS-CoV-2, quickly spread worldwide within a few months. Although coronaviruses typically infect the upper or lower respiratory tract, the virus RNA can be detected in plasma. The risk of transmitting coronavirus via transfusion of blood products remains. As more asymptomatic infections are identified in COVID-19 cases, blood safety has become particularly important. Methylene blue (MB) photochemical technology has been proven to inactivate lipid-enveloped viruses with high efficiency and safety. The present study aimed to investigate the SARS-CoV-2 inactivation effects of MB in plasma. METHODS: The SARS-CoV-2 virus strain was isolated from Zhejiang University. The live virus was harvested from cultured VERO-E6 cells, and mixed with MB in plasma. The MB final concentrations were 0, 1, 2, and 4 µM. The "BX-1 AIDS treatment instrument" was used at room temperature, the illumination adjusted to 55,000 ± 0.5 million Lux, and the plasma was irradiated for 0, 2, 5, 10, 20, and 40 mins using light at a single wavelength of 630 nm. Virus load changes were measured using quantitative reverse transcription- PCR. RESULTS: BX-1 could effectively eliminate SARS-CoV-2 within 2 mins in plasma, and the virus titer declined to 4.5 log10 TCID50 (median tissue culture infectious dose)/mL. CONCLUSION: BX-1 is based on MB photochemical technology, which was designed to inactivate HIV-1 virus in plasma. It was proven to be safe and reliable in clinical trials of HIV treatment. In this study, we showed that BX-1 could also be applied to inactivate SARS-CoV-2. During the current outbreak, this technique it has great potential for ensuring the safety of blood transfusions, for plasma transfusion therapy in recovering patients, and for preparing inactivated vaccines.


Subject(s)
Blood Safety , COVID-19/prevention & control , COVID-19/therapy , Methylene Blue/pharmacology , SARS-CoV-2/drug effects , Virus Inactivation , Animals , Blood Transfusion , Chlorocebus aethiops , Humans , Immunization, Passive , Plasma/virology , RNA, Viral , Vero Cells
11.
Transfusion ; 61(9): 2668-2676, 2021 09.
Article in English | MEDLINE | ID: covidwho-1297942

ABSTRACT

BACKGROUND: Although the safety and therapeutic efficacy of COVID-19 convalescent plasma (CCP) has been extensively evaluated, the safety of CCP donation has not been explored in a multi-institutional context. STUDY DESIGN AND METHODS: Nine blood collection organizations (BCOs) participated in a multi-institutional donor hemovigilance effort to assess the safety of CCP donation. Donor adverse events (DAEs) were defined according to the Standard for Surveillance of Complications Related to Blood Donation, and severity was assessed using the severity grading tool. Multivariate analysis was performed to determine attributes associated with DAE severity. RESULTS: The overall DAE rate was 37.7 per 1000 donations. Repeat apheresis and apheresis-naïve donors experienced adverse event rates of 19.9 and 49.8 per 1000 donations, respectively. Female donors contributed 51.9% of CCP donations with a DAE rate of 49.4 per 1000 donations. The DAE rate for male donors was 27.4 per 1000 donations. Vasovagal reactions accounted for over half of all reported DAEs (51.1%). After adjustment, volume of CCP donated was associated with vasovagal reaction severity (odds ratio [OR] 6.5, 95% confidence interval [CI] 2.5-17.1). Donor age and donation history were also associated with DAE severity. Considerable differences in DAE types and rates were observed across the participating BCOs despite the use of standardized hemovigilance definitions. CONCLUSION: The safety of CCP donation appears comparable to that of conventional apheresis plasma donation with similar associated risk factors for DAE types and severity.


Subject(s)
Blood Donors , Blood Safety , COVID-19/blood , COVID-19/immunology , SARS-CoV-2/immunology , Adolescent , Adult , Aged , Aged, 80 and over , COVID-19/diagnosis , COVID-19/epidemiology , Female , Humans , Male , Middle Aged , Odds Ratio , Public Health Surveillance , Retrospective Studies , Severity of Illness Index , United States/epidemiology , Young Adult
13.
Transfusion ; 61(8): 2384-2391, 2021 08.
Article in English | MEDLINE | ID: covidwho-1247294

ABSTRACT

BACKGROUND: SARS-CoV-2 RNA prevalence in blood donors from large geographic areas of high community transmission is limited. We tested residual donor plasma minipools (MPs) to determine SARS-CoV-2 RNAemia prevalence in six United States areas. STUDY DESIGN/METHODS: Blood donations collected from 7 March 2020 to 25 September 2020 were tested for SARS-CoV-2 RNA (vRNA) in MP of 6 or 16 donations using the Grifols Procleix SARS-CoV-2 research-use only (RUO) transcription-mediated amplification (TMA) assay. Reactive results were confirmed using an alternate target region TMA assay. Reactive MPs were tested by TMA after serial dilution to estimate viral load. Testing for anti-SARS-CoV-2 antibodies and infectivity was performed. RESULTS: A total of 17,995 MPs corresponding to approximately 258,000 donations were tested for vRNA. Three confirmed reactive MP16 were identified. The estimated prevalence of vRNA reactive donations was 1.16/100,000 (95% CI 0.40, 3.42). The vRNA-reactive samples were non-reactive for antibody, and the estimated viral loads of the (presumed single) positive donations within each MP ranged from <1000 to <4000 copies/ml. When tested, no infectivity was observed in inoculated permissive cell cultures. DISCUSSION: Blood donation MP-nucleic acid testing (NAT) indicated that SARS-CoV-2 RNAemia is infrequent and, when detected, the vRNA was at low concentrations. Only one RNA-reactive MP could be tested for infectivity for operational reasons and was not infectious in cell culture. These findings support current recommendations from international and national regulatory agencies to not screen donors by NAT.


Subject(s)
Blood Donors , Blood Safety , COVID-19 Nucleic Acid Testing , COVID-19/diagnosis , RNA, Viral/analysis , SARS-CoV-2/isolation & purification , Humans , United States
15.
Vox Sang ; 116(5): 497-503, 2021 May.
Article in English | MEDLINE | ID: covidwho-1241034

ABSTRACT

INTRODUCTION: Numerous concerns regarding maintenance of blood inventory have been raised after SARS-CoV-2 pandemic outbreak. These concerns were based on the experience of blood centres in previous pandemics where shortage of blood components was reported. The present study had tried to understand the impact of SARS-CoV-2 pandemic on blood collection and demand as well as the impact of disaster planning in maintaining an adequate inventory. METHODS: Data related to blood supply and demand were collected retrospectively using blood bank management software for pre-COVID-19 and COVID-19 time period and compared. Strategies adopted and effects of changes in existing disaster plans to maintain an adequate inventory were studied. RESULTS: A drastic fall in the red cell inventory was observed as compared to pre-COVID-19 time period was observed due to disproportionate decrease in blood collection (1/6 to 1/9 of the previous collection) and demand (1/2 of the previous demand). The buffer stock fell gradually over a period of three weeks with cancellation of planned blood donation drives. A buffer stock equivalent to 2-week inventory led to adequate inventory in the initial lockdown periods. Similar fall was observed in the platelet inventory with reduction in the blood collection but almost a proportionate reduction in the platelet demand led to adequate inventory. No increase in wastage was observed for both red cells and platelets during this period. DISCUSSION: A buffer stock of blood and blood components, strict adherence to the transfusion triggers, good coordination with the clinical staff and a prospective review of blood transfusion requests to ensure rational blood transfusion were some of the steps which helped us to successfully maintain transfusion requirements in the initial phases of the COVID-19 pandemic. Use of first-in-first-out policy prevented any wastage due to outdating of blood.


Subject(s)
Blood Banks/organization & administration , Blood Safety/standards , COVID-19/epidemiology , Blood Banks/standards , Blood Donors/supply & distribution , Blood Safety/methods , Hospitals/standards , Humans
16.
Transfus Apher Sci ; 60(4): 103154, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1230803

ABSTRACT

BACKGROUND: Convalescent plasma (CP) has been used in the past in various pandemics, in particular in H1N1, SARS and MERS infections. In Spring 2020, when ongoing the SARS-CoV-2 pandemics, the Veneto Region (V-R) has proposed setting-up an anti-SARS-CoV-2 CP (CCP) Bank, with the aim of preparing a supply of CCP immediately available in case of subsequest epidemic waves. MATERIALS AND METHODS: Key-points to be developed for a quick set-up of the V-R CCP Bank have been recruitment of donors recovered from COVID-19 infection, laboratory analysis for the biological qualification of the CCP units, including titre of neutralizing antibodies and reduction of pathogens, according to National Blood Centre (CNS) Directives, adaptation of the V-R Information Technology systems and cost analysis. Some activities, including diagnostic and viral inactivation processes, have been centralized in 2 or 3 sites. Laboratory analysis upon preliminary admission of the donor included all tests required by the Italian laws and the CNS directives. RESULTS: From April to August 2020, 3,298 people have contacted the V-R Blood Transfusion Services: of these, 1,632 have been evaluated and examined as first time donors and those found to be suitable have carried out 955 donations, from which 2,626 therapeutic fractions have been obtained, at a cost around 215,00 Euro. Since October 2020, the number of COVID-19 inpatients has had a surge with a heavy hospital overload. Moreover, the high request of CCP therapy by clinicians has been just as unexpected, showing a wide therapeutic use. CONCLUSIONS: The organizational model here presented, which has allowed the rapid collection of a large amount of CCP, could be useful when facing new pandemic outbreaks, especially in low and middle income countries, with generally acceptable costs.


Subject(s)
Blood Banks/organization & administration , COVID-19/therapy , Civil Defense/organization & administration , Pandemics , Antibodies, Neutralizing/blood , Antibodies, Viral/blood , Blood Banks/economics , Blood Donors , Blood Safety/methods , Blood-Borne Infections/prevention & control , Costs and Cost Analysis , Donor Selection/legislation & jurisprudence , Humans , Immunization, Passive/statistics & numerical data , Italy , Models, Organizational , Plasma , SARS-CoV-2/immunology , Virus Inactivation
17.
Transfus Clin Biol ; 28(3): 308-309, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1221045

ABSTRACT

Clinical management protocols for COVID-19 are evolving rapidly as more information about the epidemiology and pathophysiological changes in COVID-19 become available. However, no definite treatment of COVID-19 has been found till date. The COVID-19 convalescent plasma (CCP) therapy has emerged as an important investigational therapy in the management of COVID-19 patients. Additionally, the regulatory agencies, in particular, the Indian blood transfusion council must release some interim recommendations for the blood centres on the CCP blood donor eligibility criteria after COVID-19 vaccination. More clinical trials are needed to know the efficacy of the CCP harvested from COVID-19 recovered individuals who have been vaccinated against those COVID-19 recovered individuals who are not vaccinated to understand the vaccine impact on the IgG titres of anti-SARS-CoV-2 antibodies.


Subject(s)
Antibodies, Viral/therapeutic use , Blood Safety , COVID-19 Vaccines , COVID-19/therapy , Donor Selection/standards , Immunoglobulin G/therapeutic use , Pandemics , SARS-CoV-2/immunology , Antibodies, Viral/blood , Antibodies, Viral/immunology , COVID-19/blood , COVID-19/immunology , Human Experimentation , Humans , Immunization, Passive/ethics , Immunization, Passive/standards , Immunoglobulin G/blood , Immunoglobulin G/immunology , Informed Consent , Viral Proteins/immunology
18.
Transfus Apher Sci ; 60(4): 103129, 2021 Aug.
Article in English | MEDLINE | ID: covidwho-1195468

ABSTRACT

Call back as a procedure to report post donation symptoms or illness by donors has been established since 2009 in Iranian Blood Transfusion Organization (IBTO). During the first phase of COVID-19 outbreak, all blood donors were requested to report any respiratory infection symptoms after donation. The study investigated the callback data of COVID-19 in Tehran Blood Center during the first 3 months of the outbreak in Iran. The purpose of this study was to estimate the frequency of post donation COVID-19 related call back reports and determine its implications for blood donors and patients. A telephone interview was conducted with donors who had reported COVID-19 symptoms. Some questions were asked to evaluate donor's health at the time of blood donation. The donors categorized into three groups: laboratory-confirmed, suspected, and COVID-19 irrelevant based on their answers. In cases that the blood component obtained from a laboratory-confirmed donor had been released, the hospital was notified and asked to follow up the recipient for COVID-19. The results showed 30 donors (0.08 %) had callback related to COVID-19 and 76.63 % of the obtained component was disposed. The results also showed that only one donor had a laboratory-confirmed result with the RBC unit processed from her whole blood released for transfusion. The RBC unit recipient did not show any signs or symptoms of infection during a 46-day follow-up. Concluded that callback system was effective to remove most of the components obtained from the donors who reported to be COVID-19 suspected or confirmed. Moreover, the result did not support virus transmission through blood transfusion.


Subject(s)
Blood Donors , Blood Safety , Blood-Borne Infections/prevention & control , COVID-19/prevention & control , Donor Selection , Pandemics , SARS-CoV-2 , Transfusion Reaction/prevention & control , Adult , Aged , Blood Component Transfusion/adverse effects , Blood Component Transfusion/statistics & numerical data , COVID-19/blood , COVID-19/diagnosis , COVID-19/transmission , COVID-19 Nucleic Acid Testing , Erythrocyte Transfusion/adverse effects , Female , Follow-Up Studies , Humans , Infant, Newborn , Interviews as Topic , Iran/epidemiology , Male , Middle Aged , Pulmonary Valve Stenosis/surgery , Symptom Assessment , Young Adult
19.
BMC Infect Dis ; 21(1): 357, 2021 Apr 16.
Article in English | MEDLINE | ID: covidwho-1190056

ABSTRACT

BACKGROUND: In 2020, a new coronavirus, SARS-CoV-2, quickly spread worldwide within a few months. Although coronaviruses typically infect the upper or lower respiratory tract, the virus RNA can be detected in plasma. The risk of transmitting coronavirus via transfusion of blood products remains. As more asymptomatic infections are identified in COVID-19 cases, blood safety has become particularly important. Methylene blue (MB) photochemical technology has been proven to inactivate lipid-enveloped viruses with high efficiency and safety. The present study aimed to investigate the SARS-CoV-2 inactivation effects of MB in plasma. METHODS: The SARS-CoV-2 virus strain was isolated from Zhejiang University. The live virus was harvested from cultured VERO-E6 cells, and mixed with MB in plasma. The MB final concentrations were 0, 1, 2, and 4 µM. The "BX-1 AIDS treatment instrument" was used at room temperature, the illumination adjusted to 55,000 ± 0.5 million Lux, and the plasma was irradiated for 0, 2, 5, 10, 20, and 40 mins using light at a single wavelength of 630 nm. Virus load changes were measured using quantitative reverse transcription- PCR. RESULTS: BX-1 could effectively eliminate SARS-CoV-2 within 2 mins in plasma, and the virus titer declined to 4.5 log10 TCID50 (median tissue culture infectious dose)/mL. CONCLUSION: BX-1 is based on MB photochemical technology, which was designed to inactivate HIV-1 virus in plasma. It was proven to be safe and reliable in clinical trials of HIV treatment. In this study, we showed that BX-1 could also be applied to inactivate SARS-CoV-2. During the current outbreak, this technique it has great potential for ensuring the safety of blood transfusions, for plasma transfusion therapy in recovering patients, and for preparing inactivated vaccines.


Subject(s)
Blood Safety , COVID-19/prevention & control , COVID-19/therapy , Methylene Blue/pharmacology , SARS-CoV-2/drug effects , Virus Inactivation , Animals , Blood Transfusion , Chlorocebus aethiops , Humans , Immunization, Passive , Plasma/virology , RNA, Viral , Vero Cells
20.
Vox Sang ; 116(3): 296-304, 2021 Mar.
Article in English | MEDLINE | ID: covidwho-1171213

ABSTRACT

BACKGROUND AND OBJECTIVES: While coronavirus (COVID-19) is not transfusion-transmitted, the impact of the global pandemic on blood services worldwide is complex. Convalescent plasma may offer treatment, but efficacy and safety are not established. Measuring seroprevalence in donors would inform public health policy. Here, we survey blood services around the world to assess the different research programmes related to COVID-19 planned or in progress. MATERIALS AND METHODS: Blood collection services were surveyed in June 2020 to determine whether they were participating in serosurveys or convalescent plasma collection and clinical trials. RESULTS: A total of 48 countries (77% of those contacted) responded. Seroprevalence studies are planned or in progress in 73% of countries surveyed and in all continents, including low- and middle-income countries. Most aimed to inform public health policy. Convalescent plasma programmes have been initiated around the globe (79% of surveyed), about three quarters as clinical trials in high-, middle- and low-income countries. CONCLUSION: Blood services around the world have drawn upon their operational capacity to provide much-needed seroprevalence data to inform public health. They have rapidly implemented preparation of potential treatment when few treatments are available and mostly as clinical trials. At the same time, they must continue to provide blood products for recipients despite challenges of working in a state of emergency. It is important to track and coordinate research efforts across jurisdictions to gain a composite evidence-based view that will influence future practice and preparative strategies.


Subject(s)
Blood Banks/organization & administration , Blood Safety , COVID-19/blood , COVID-19/therapy , COVID-19/transmission , Blood Donors , COVID-19/prevention & control , Geography , Health Policy , Humans , Immunization, Passive/methods , Pandemics , Phlebotomy , Public Health , Seroepidemiologic Studies , Surveys and Questionnaires
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