Development of an instrument-free molecular diagnostic test for Influenza and RSV

影响患者呼吸的感染，如流感和呼吸道合胞病毒（RSV），每年在全球造成600多万人住院，70万人死亡。它们尤其影响65岁以上、5岁以下和慢性疾病患者，如慢性阻塞性肺病。有必要改进呼吸道疾病的诊断和治疗，包括允许在最有效的时候使用抗病毒药物，并在不需要时减少抗生素的使用。用于检测病毒遗传物质的流感和RSV实验室诊断测试非常准确，但需要复杂的设备，这需要一个中央测试地点和相关的操作系统，这增加了成本并造成延误。快速的即时检测，类似于妊娠试验，可用于流感和RSV，自20世纪90年代初以来一直在美国使用。它们既便宜又方便，但遗漏了许多感染病例，而且不可靠。我们开发了一种一次性分子测试设备，将实验室机器测试的金标准性能带入快速，一次性，即时测试格式。该产品具有高度的灵活性，可以在中心实验室之外随时采用。我们的测试的好处包括改善病人的治疗，减少住院，更好地使用抗生素，减少死亡和显著降低总体医疗成本。未来在医院、全科医生和养老院使用也将使感染预防和控制更加有效。

Infections that affect patients breathing, such as influenza and respiratory syncytial virus (RSV), cause over 6 million hospital admissions and c.700,000 deaths globally each year. They particularly impact over 65s, under 5s and patients with chronic disease, e.g. COPD. There is an important need to improve the diagnosis and treatment of respiratory illnesses, including permitting antiviral drugs to be used when they are most effective and cutting the use of antibiotics when they are not required. Laboratory diagnostic tests for influenza and RSV which detect the genetic material of the viruses are very accurate but need complex equipment, which necessitates a central testing location and the associated operating systems which add costs and cause delays. Rapid point-of-care tests, similar to a pregnancy test, are available for influenza and RSV and have been used in the USA since the early 1990s. They are cheap and convenient but miss many cases of infection and are unreliable. We have developed a single-use molecular test device that brings the gold standard performance of laboratory machine tests into a rapid, disposable, point-of-care test format. The product is highly flexible and may be readily adopted outside of central laboratories. The benefits of our test include improved treatment of patients, fewer hospitalisations, better use of antibiotics, fewer deaths and significantly lower overall healthcare costs. Future use by hospitals, GPs and nursing homes would also enable more effective infection prevention and control.