Problem: Detecting and quantifying Anti-ABO antibodies is essential for some medical procedures, such aswhole blood transfusion and ABO-incompatible solid organ transplant and could greatly impact patient care forother indications, such as hemolytic disease of the fetus and newborn. However, current testing methods areencumbered by the need for large blood samples, transportation to centralized laboratories, time to centrifugeand perform testing of serial dilutions, specialized reagents and technical training needs, and technical variabilitybetween users and sites. Thus, there is a need for antibody detection and quantification that is standardized,multiplexed, and automated while simultaneously providing for speed and lower cost. Solution: SiDx hasdemonstrated the promise of our technology in proof-of-concept studies to detect A, B, RhD (D), C, E, and Kellblood group antigens in small volume blood samples and is working to multiplex these assays forcommercialization. However, detection and quantification of anti-ABO antibodies presents further technicalchallenges. This SBIR application is seeking SBIR support to determine the feasibility of detecting and semi-quantitatively characterizing isotype-specific anti-ABO antibodies using silicon photonic biosensors. We proposeto do this in two aims: In Aim 1, we propose developing proof-of-concept assays for IgG, IgM, and total anti-ABO antibodies. In Aim 2, we propose detecting and semi-quantitatively characterizing anti-ABO IgG antibodiesin O-type samples over a physiologic range of titers. This work will provide data to support a SBIR phase IIapplication in which we will propose optimization of the assays developed in phase I and quantitative analysis ofIgG and IgM antibodies as well as providing a road map for future work on detection and quantification of otherantibodies on our platform. Impact: This silicon photonic blood typing platform holds the promise to modernizeblood group testing with simple, fast, fully automated, multiplexed blood group testing in small volume bloodsamples. The addition of quantitative and isotype-specific information about anti-ABO antibodies will increasethe value of the SiDx platform by providing more actionable information in an easy to use automated test. Wepredict that this product will transform both blood group testing and transfusion medicine through small samplevolume, fully automated testing, and rapid time to results.
Public Health Relevance Statement: NARRATIVE
Anti-ABO antibody detection and quantification is necessary in multiple medical indications, including ABO-
incompatible transplantation and whole blood transfusion, and could be used to screen for pregnancies at risk
for ABO-mediated hemolytic disease of the fetus and newborn if it were not cost-prohibitive. However, current
antibody isotype identification and quantification methods require large volume blood samples, must be sent to
a specialized laboratory where processing and testing is performed by trained laboratory staff, and have a great
deal of technical variability between measurements. We propose to determine the feasibility of using a silicon
photonic blood group testing chip assay that can detect and quantify isotype-specific anti-ABO antibodies using
a small sample quickly, easily, and near the patient, without the need for specialized laboratory methods.
Project Terms: ABO blood group system ; ABH Blood Group ; ABO blood groups ; ABO(H) blood groups ; H Blood Group ; H Blood Group System ; Algorithms ; Antibodies ; Antigens ; immunogen ; Biological Assay ; Assay ; Bioassay ; Biologic Assays ; Blood ; Blood Reticuloendothelial System ; Blood Banks ; Blood Group Antigens ; blood group ; Blood Transfusion ; Blood typing procedure ; Blood Grouping ; Blood Typing ; Blood Volume ; Chemistry ; Disease ; Disorder ; Enzyme-Linked Immunosorbent Assay ; ELISA ; Fetus ; Future ; Patient Care ; Patient Care Delivery ; Geography ; Health Personnel ; Health Care Providers ; Healthcare Providers ; Healthcare worker ; health care personnel ; health care worker ; health provider ; health workforce ; healthcare personnel ; medical personnel ; treatment provider ; Immunoglobulin G ; 7S Gamma Globulin ; IgG ; Immunoglobulin M ; 19S Gamma Globulin ; IgM ; Immunoglobulins ; Immune Globulins ; Newborn Infant ; 0-4 weeks old ; Newborns ; newborn child ; newborn children ; Laboratories ; Maps ; Methods ; Military Personnel ; Armed Forces Personnel ; Military ; military population ; Modernization ; Organ Transplantation ; Grafting Procedure ; Organ Transplants ; organ allograft ; organ graft ; organ xenograft ; Patients ; Polysaccharides ; Glycans ; Pregnancy ; Gestation ; Reagent ; Research ; Risk ; Sensitivity and Specificity ; Silicon ; Si element ; sound ; Standardization ; Technology ; Testing ; Time ; Transplantation ; transplant ; Transportation ; Universities ; Washington ; Work ; Walking ; Diagnostic tests ; Mediating ; Blood specimen ; Blood Sample ; sensor ; improved ; Procedures ; Transfusion ; Site ; Area ; Surface ; Solid ; Phase ; Physiological ; Physiologic ; Medical ; Training ; Measurement ; Whole Blood ; Event ; Protocol ; Protocols documentation ; System ; experience ; success ; biological sensor ; Biosensor ; Speed ; Structure ; Devices ; Manpower ; personnel ; Human Resources ; Nervous System Injuries ; Nervous System damage ; Neurological Damage ; Neurological Injury ; Neurological trauma ; neurotrauma ; Nervous System Trauma ; Sampling ; photonics ; ChIP assay ; chromatin immunoprecipitation ; Data ; Detection ; Reproducibility ; Small Business Innovation Research Grant ; SBIR ; Small Business Innovation Research ; Monitor ; Preparation ; Development ; developmental ; neonate ; cost ; Consumption ; innovation ; innovate ; innovative ; commercialization ; adverse outcome ; adverse consequence ; mass casualty ; laboratory experience ; lab experience ; lab training ; laboratory training ; treatment optimization ; therapy optimization ; transfusion medicine ; antibody detection ; antibody based detection ; detect antibodies ; detection test ; detection tests ; detection method ; detection procedure ; detection technique ; multiplex assay ;
