LABScreen™ Multi for Blood Screening

A multiplex assay for both HLA and HNA screening

Improve the Safety of Transfusions with Screening for HLA and HNA Donor Antibodies

Plasma plays a critical role in supplying patients with trauma, burns, liver or clotting issues many of the proteins that are necessary to support blood clotting and immune system responses. Patients who receive plasma-containing products may be at risk for Transfusion-Related Acute Lung Injury (TRALI), a rare but serious syndrome characterized by sudden acute respiratory distress (ARDS) following transfusion.11

In the majority of cases, TRALI is immune-mediated: an analysis of 36 patients showed that donor anti-HLA or anti-HNA antibodies were present in 89% of cases.”14

TRALI is fatal in 5-10% of all cases.12

Mitigate TRALI Risk With Simultaneous Detection of HLA and HNA Antibodies in a Single Well

Current research suggests that both anti-HLA and anti-HNA antibodies have been implicated in clinical cases of TRALI.14 LABScreen Multi is the only FDA cleared assay for the simultaneous detection of HLA and HNA antibodies.* More specifically, antibodies directed against HNA 1a, 1b and 2a are with severe forms of TRALI, whereas anti-HNS-3a is often associated with fatal TRALI.15,16 Single antigen technology allows for the identification of HLA Class I, HLA Class II, and individual HNA specificities HNA-1, 2, 3, 4, and 5, providing 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.

In addition, research shows that HLA type play an integral role in population level immune monitoring and vaccine development as the COVID-19 pandemic continues to evolve. Convalescent plasma therapy, which is being investigated as a treatment for COVID-19 infection, may increase a patient's risk for TRALI. COVID patients who develop acute respiratory distress syndrome, or who may progress to ARDS, may also face a higher risk of TRALI due to their underlying lung injury.13

Read more about the role HLA play in the SARS disease.

LABScreen Multi Workflow

LABScreen Multi offers an easy, efficient method for donor screening, allowing laboratory professionals to screen up to 96 samples in less than 4 hours with a simple immunoassay protocol.

LABScreen step 1 "Add Sample" graphic

Add Sample

LABScreen step 2 "Wash" graphic

Wash

LABScreen step 3 "Add R-PE Conjugated Anti-IgG" graphic

Add
R-PE Conjugated Anti-lgG

LABScreen step 4 "Wash" graphic

Wash

LABScreen step 5 "Read" graphic

Read

LABScreen graphics key

*LABScreen Multi is not associated with the diagnosis or treatment of TRALI.

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Our Solutions

LABScreen™ Multi
LabScreen Multi, a multiplex assay, is a screening tool for antibodies against both the HLA and Human Neutrophil Antigens (HNA).
References
  1. Casadevall A and Pirofsk, L. “The convalescent sera option for containing COVID-19.” The Journal of Clinical Investigation 130, 4 (March 2020): 1545-1548
  2. 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.
  3. 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).
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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).
  11. 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)
  12. Popovsky MA and Moore SB. “Diagnostic and pathogenetic considerations in transfusion-related acute lung injury.” Transfusion 25, 6 (December 1985): 573-577.
  13. 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).
  14. Popovsky MA, Chaplin HC, Moore SB. “Transfusion-related acute lung injury: a neglected, serious complication of hemotherapy.” Transfusion 32, 6 (August 1992): 589-592.
  15. Stroncek DF. “Pulmonary transfusion reactions.” Seminars in Hematology 44, 1 (January 2007): 2-14.
  16. 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.
  17. 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).
  18. FDA Issued Guidance. “Recommendations for Investigational COVID-19 Convalescent Plasma.” (Content current as of May 2020).
  19. Sher, G and Markowitz, MA. “AABB Association Bulletin #14-02: TRALI Risk Mitigation for Plasma and Whole Blood for Allogeneic Transfusion.” (January 2014).
  20. 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).