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

肝素诱导的血小板减少症（HIT）是一种抗体介导的抗凝药物肝素的不良反应。立即诊断和治疗至关重要，因为20-50%的HIT患者会形成血栓，其中30%的患者是致命的。然而，医生很难诊断HIT，因为很难在患者身上检测到具有临床意义的抗体。大多数接触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，并且可能延迟诊断。因此，许多医生会在得到实验室确认之前进行治疗，这可能会对患者产生不利的副作用。对于医院来说，HIT的过度诊断和过度治疗也与财政负担增加有关。为了缓解这个问题，我们设计了一种抑制剂，可以通过在标准免疫测定中竞争HIT抗体的结合来检测其存在。这些抑制剂可用于改善现有的基于免疫测定的诊断，以提高其当前的性能。因此，我们的测试将有更快的周转时间，并且可以在任何临床实验室轻松地进行技术操作。该产品还将在不影响患者预后的情况下提供快速且具有成本效益的解决方案。

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.