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

诊断试验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）。大多数诊断测试都是简单的平板检测或妊娠试验类型的检测——在大多数实验室或全科医生手术中便宜且易于操作，但往往灵敏度和特异性较差。例如，如果生殖器沙眼衣原体存在，肺炎衣原体检测可能会出现假阳性，而登革热病毒检测西尼罗河病毒和蜱传脑炎可能呈阳性。斑块减少中和试验（prnt）绕过了这些交叉反应性问题，是目前的金标准诊断试验，但它们使用的活病原体通常处理起来非常危险，可能需要长达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，而且成本很高。prnt也被用于疫苗研究，在疫苗研究中，中和抗体的数量被用作衡量疫苗有效性的一个指标。必须在高度生物防护的设施中进行这些测试，提高了疫苗研究的成本和开发成功疫苗的速度。我们的新测试旨在提供aPRNT的特异性和敏感性，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帮助改善许多人类和动物疾病的诊断，并促进和加强针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.