Development of a novel, rapid and safe neutralising antibody diagnostic kit by The Native Antigen Company

诊断测试是疾病诊断和疫苗研究的重要组成部分。对于任何测试，重要的参数是灵敏度（即测试正确识别阳性样本的能力）和特异性（即正确区分不同疾病的能力）。大多数诊断测试是简单的基于板的测定或妊娠试验类型的测定-便宜且易于在大多数实验室或GP手术中运行，但通常具有较差的灵敏度和特异性。例如，如果存在生殖道沙眼衣原体，则肺炎衣原体检测可能呈假阳性，而登革热病毒检测对西尼罗河病毒和蜱传脑炎呈阳性。空斑减少中和试验（PRNT）解决了这些交叉反应性问题，目前是诊断试验的金标准，但它们使用的活病原体通常非常危险，需要长达10天的时间才能完成。这意味着它们只能在罕见的专业实验室中进行，并且测试成本很高。PRNT也用于疫苗研究，其中中和抗体的数量被用作衡量疫苗有效性的指标。必须在高生物防护设施中进行这些测试，这增加了疫苗研究的成本和开发有效疫苗的速度。我们的新测试旨在提供aPRNT的特异性和灵敏度，但使用100%安全的试剂，仅需1天即可完成。我们相信，这将极大地有助于改善对许多人类和动物疾病的诊断，并促进对危险病原体的疫苗研究。

Diagnostic tests are a vital component of disease diagnosis and vaccine research. For any test,the important parameters are sensitivity (i.e. the ability of the test to correctly identify apositive sample) and specificity (i.e. its ability to discriminate correctly between differentdiseases). Most diagnostic tests are simple plate-based assays or pregnancy test-type assays –cheap and easy to run in most labs or GP surgeries, but often suffer from poor sensitivity andspecificity. For example, tests for Chlamydia pneumonia can be false positive if genitalChlamydia trachomatis is present, and dengue virus tests come up positive for West Nile virusand tick-borne encephalitis. Plaque reduction neutralisation tests (PRNTs) get around thesecross-reactivity problems, and are currently the gold standard diagnostic test, but they use livepathogens that are often extremely hazardous to handle and can take up to 10 days to perform.This means they can only be done in rare specialised laboratories and have a high cost pertest. PRNTs are also used in vaccine research, where the number of neutralising antibodies isused as a measure for how efficacious a vaccine is. Having to perform these tests in highbiocontainment facilities raises the cost of vaccine research and the speed to develop asuccessful vaccine. Our novel test is designed to provide the specificity and sensitivity of aPRNT, but with 100% safe reagents and taking only 1 day to perform. We believe this wouldbe of great help to improve diagnosis for many human and animal diseases and to enable andenhance vaccine research into hazardous pathogens.