Mitigate TRALI risk with simultaneous detection of HLA and HNA antibodies in a single well
Convalescent plasma therapy’s potential role in COVID-19
The rise of the severe acute respiratory syndrome coronavirus 2 (SARS–CoV-2), the cause of coronavirus disease 2019 (COVID-19), has spurred a global health crisis. Although many treatments are in rapid development, to date there are no drugs, vaccines, or options for prophylaxis. Human convalescent plasma has been shown to have a positive impact on COVID-19 patients and could become available when a sufficient number of people have recovered and can donate blood containing neutralizing antibodies1.
Research indicates convalescent plasma therapy may help fight viral infections
Collected from patients who have recovered from COVID-19, convalescent plasma contains SARS-Cov-2 specific neutralizing antibodies. Passive antibody administration through transfusion of convalescent plasma may be the only short-term strategy for providing immediate immunity to susceptible individuals2. This treatment has been studied in outbreaks of numerous respiratory infections3 including the 2003 SARS-Cov-1 epidemic4, 2009 H1N1 influenza pandemic5, and 2012 MERS-Cov epidemic6. These studies as well as recent data on SARS-Cov-27, 8, 9 suggest that convalescent plasma therapies have the potential to reduce the severity or shorten the length of illness caused by COVID-19.
TRALI is a significant barrier to the potential of convalescent plasma therapy for COVID-19
Transfusion-related acute lung injury (TRALI) is a serious pulmonary syndrome that, if not recognized and treated, can lead to death10. Patients who receive plasma-containing products may be at risk for TRALI; it is consistently a leading cause of transfusion-related mortality11 and has been found to be fatal in 5-10% of all cases12. COVID-19 patients with acute respiratory distress syndrome (ARDS), or who may progress to ARDS, may have a higher risk of TRALI due to their underlying lung injury13.
Donor anti-HLA and anti-HNA antibodies are associated with TRALI
The cause of TRALI may be attributed to either anti-HLA or anti-HNA antibodies considering that 89% of cases involve donors who have one or both antibody types present14. Reports show that antibodies directed against HNA 1a, 1b and 2a are associated with severe forms of TRALI15. Anti-HNA-3a is believed to cause significant morbidity and is most often associated with fatal TRALI16.
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LABScreen™ Multi — HLA and HNA antibody detection test to efficiently stratify the risk of TRALI
Advanced TRALI Mitigation through HNA and HLA Detection
Fast and effective antibody screening is critical to improving the safety of plasma therapies and increasing the potential pool of eligible donors. All LABScreen tests are cleared for in vitro diagnostic use and follow a streamlined workflow for processing up to 96 samples per run on both the LABScan™ 100 and LABScan3D™ platforms.
One Lambda’s LABScreen Multi is the only HLA and HNA antibody detection test available to efficiently stratify the risk of TRALI
LABScreen Multi is the only FDA cleared assay for the simultaneous detection of HLA and HNA antibodies. Single antigen technology allows for the identification of individual HNA specificities HNA-1, 2, 3, 4, and 5. Coverage that meets international recommendations and exceeds standards set by the FDA and AABB. Optimized for the transfusion medicine community, the LABScreen Multi assay can maximize your pool by retaining more donors without compromising patient safety.
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The Importance of HLA and HNA Antibody Screening: International Donor Eligibility Guidelines
Guidelines for the Blood Transfusion Services from the Joint United Kingdom Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee
17.4: HNA antibody detection methods
Laboratories should use tests with adequate sensitivity for the detection and identification of HNA-reactive antibodies. It is recommended that more than one technique is used to detect HNA-specific antibodies. The combination of chosen technique(s)…must ensure:
- The detection of clinically significant HNA-reactive alloantibodies to the antigens of the HNA-1, HNA-2, HNA-3, HNA-4 and HNA-5 systems.
- The detection and identification of HNA-reactive antibodies in samples containing a mixture of both HNA and HLA-reactive antibodies, including antibodies to HNA-3 system antigens, which is expressed on both granulocytes and lymphocytes.
- The identification of the individual HNA specificities in samples containing mixtures of alloantibodies against several HNA antigens (e.g. masking of certain HNA specificities by composition of the panel).17
FDA Recommendations for Investigational COVID-19 Convalescent Plasma and American Association of Blood Banks (AABB) Transfusion Service Standards
Collection of COVID-19 Convalescent Plasma, Section 1. Donor Eligibility
COVID-19 convalescent plasma is collected from individuals who meet the following qualifications:
- Male donors, or female donors who have not been pregnant, or female donors who have been tested since their most recent pregnancy and results interpreted as negative for HLA antibodies.18,19
International Society of Blood Transfusion (ISBT) Working Party on Global Blood Safety
Points to consider in the preparation and transfusion of COVID-19 convalescent plasma
Eligibility of convalescent COVID-19 patients to donate whole blood or plasma should be based on:
- To avoid the risk of Transfusion Related Acute Lung Injury (TRALI) preference should be given to use of plasma from male donors or from female donors who have never been pregnant including abortions. This measure lowers the possibility of presence in the plasma of the antibodies to HLA or granulocyte antigens that cause TRALI. TRALI occurs within 6 hours after transfusion of implicated plasma and can be severe.20
- Casadevall A and Pirofsk, L. “The convalescent sera option for containing COVID-19.” The Journal of Clinical Investigation 130, 4 (March 2020): 1545-1548
- Bloch E et al. “Deployment of convalescent plasma for the prevention and treatment of COVID-19.” The Journal of Clinical Investigation 130, 6 (June 2020): 2757-2765.
- WHO Blood Regulators Network (BRN). “Position Paper on Use of Convalescent Plasma, Serum or Immune Globulin Concentrates as an Element in Response to an Emerging Virus.” (September 2017).
- Cheng Y et al. “Use of convalescent plasma therapy in SARS patients in Hong Kong.” European Journal of Clinical Microbiology and Infectious Diseases 24 (December 2004): 44-46.
- Hung I et al. “Convalescent Plasma Treatment Reduced Mortality in Patients With Severe Pandemic Influenza A (H1N1) 2009 Virus Infection.” Clinical Infectious Diseases 54, 4 (February 2011): 447-456.
- Arabi YM et al. “Feasibility of Using Convalescent Plasma Immunotherapy for MERS-CoV Infection, Saudi Arabia.” Emerging Infectious Diseases 22, 9 (September 2016): 1554-1561.
- Duan K et al. “Effectiveness of convalescent plasma therapy in severe COVID-19 patients.” PNAS: Proceedings of the National Academy of Sciences of the United States of America 117, 17 (April 2020): 9490-9496.
- Shen C et al. “Treatment of 5 Critically Ill Patients With COVID-19 With Convalescent Plasma.” JAMA: The Journal of the American Medical Association 323, 16 (March 2020): 1582-1589.
- Roback, JD and Guarner J. “Convalescent Plasma to Treat COVID-19, Possibilities and Challenges” JAMA: The Journal of the American Medical Association 323, 16 (March 2020): 1561-1562.
- Zoon, KC. “Transfusion Related Acute Lung Injury (TRALI)” Department of Health and Human Services, Public Health Service, Food and Drug Administration Communication. (October 2001, Content current as of March 2018).
- FDA Center for Biologics Evaluation and Research (CBER). “Fatalities Reported to FDA Following Blood Collection and Transfusion Annual Summary for Fiscal Year 2018.” (Content current as of April 2020)
- Popovsky MA and Moore SB. “Diagnostic and pathogenetic considerations in transfusion-related acute lung injury.” Transfusion 25, 6 (December 1985): 573-577.
- Joyner MJ et al. “Early safety indicators of COVID-19 convalescent plasma in 5,000 patients.” The Journal of Clinical Investigation Online ahead of print (June 2020).
- Popovsky MA, Chaplin HC, Moore SB. “Transfusion-related acute lung injury: a neglected, serious complication of hemotherapy.” Transfusion 32, 6 (August 1992): 589-592.
- Stroncek DF. “Pulmonary transfusion reactions.” Seminars in Hematology 44, 1 (January 2007): 2-14.
- Reil A et al. “Specificities of leucocyte alloantibodies in transfusion-related acute lung injury and results of leucocyte antibody screening of blood donors.” Vox Sanguinis 95, 4 (November 2008): 313-317.
- JPAC Joint United Kingdom (UK) Blood Transfusion and Tissue Transplantation Services Professional Advisory Committee. “HNA antibody detection methods.” Guidelines for the Blood Transfusion Services (Accessed July 2020).
- FDA Issued Guidance. “Recommendations for Investigational COVID-19 Convalescent Plasma.” (Content current as of May 2020).
- Sher, G and Markowitz, MA. “AABB Association Bulletin #14-02: TRALI Risk Mitigation for Plasma and Whole Blood for Allogeneic Transfusion.” (January 2014).
- Epstein J and Burnouf T, on behalf of the ISBT Working Party on Global Blood Safety. “Points to consider in the preparation and transfusion of COVID-19 convalescent plasma therapy.” (Accessed July 2020).