L2M NSERC - High Affinity Inhibitors for the Diagnosis of Heparin Induced Thrombocytopenia

肝素诱导的血小板减少症（HIT）是对抗凝剂肝素的抗体介导的药物不良反应。及时诊断和治疗至关重要，因为20 - 50%的HIT患者会出现血栓，30%的患者会致命。然而，医生很难诊断HIT，因为很难在患者体内检测到具有临床意义的抗体。大多数暴露于肝素的患者会产生某种形式的抗体，但这些抗体中只有一小部分会引起HIT。目前，HIT诊断测试受到诊断准确性或性能可行性的限制。免疫分析测试具有很高的假阳性率，并导致许多患者接受不必要的治疗。相反，功能测试是费力的，技术上具有挑战性，并可能延迟诊断。因此，许多医生会在获得实验室确认之前进行治疗，这可能对患者产生不良副作用。对于医院来说，过度诊断和过度治疗HIT也与增加的经济负担有关。为了缓解这一问题，我们设计了一种抑制剂，可以通过在标准免疫测定中竞争它们的结合来检测致病HIT抗体的存在。这些抑制剂可用于改善现有的基于免疫测定的诊断，以提高其当前性能。因此，我们的测试将具有更快的周转时间，并且可以在任何临床实验室轻松进行。该产品还将提供快速且具有成本效益的解决方案，而不会影响患者的治疗效果。

Heparin-induced thrombocytopenia (HIT) is an antibody-mediated adverse drug reaction to the anticoagulant heparin. Immediate diagnosis and treatment is crucial as 20-50% of HIT patients will develop blood clots, which are fatal in 30% of patients. However, doctors struggle to diagnose HIT because it is difficult to detect clinically significant antibodies in patients. Most patients exposed to heparin will produce some form of antibody, but only a small percentage of these antibodies cause HIT. Currently, HIT diagnostic tests are limited by either diagnostic accuracy or performance feasibility. Immunoassay tests have high false-positive rates and cause many patients to receive unnecessary treatment. Conversely, functional tests are laborious, technically challenging, and can delay diagnosis. As such, many physicians will administer treatment before receiving laboratory confirmation, which can have adverse side-effects for patients. For hospitals, the overdiagnosis and overtreatment of HIT is also associated with an increased financial burden. To alleviate this problem, we designed an inhibitor that can be used detect the presence of disease-causing HIT antibodies by competing for their binding in a standard immunoassay. These inhibitors can be used to improve already existing immunoassay-based diagnostics to increase their current performance. Therefore, our test will have faster turn-around times and can be performed with technical ease at any clinical laboratory. This product will also provide a quick and cost-effective solution without compromising patient outcomes.