创新背景

新冠疫情以来，无论是核酸检测还是抗原检测，均需要取鼻咽样本，正确取用新的渠道样本进行检测可以提高检测速度，降低检测成本。

创新过程

鼻咽拭子样本和抗原检测在当前都还存在各自的不足之处，InspectIR COVID-19呼吸分析仪可通过呼吸样本在医生办公室、医院和移动检测站点由专业人员直接进行检测，使用气相色谱-气相质谱 (GC-MS) 技术分离和识别化学混合物，并快速检测呼出气中与 SARS-CoV-2 感染相关的五种挥发性有机化合物 (VOC)。

呼吸分析仪检测到 SARS-CoV-2 的 VOC 标记物的存在时，会返回一个假定的（未确认的）阳性检测结果，通过分子检测进行确认。阴性结果会结合患者最近的病史、接触史以及是否存在与 COVID-19 一致的临床体征和症状来考虑。因此不能简单把它当作治疗、患者管理决策或感染控制决策的唯一依据。

其性能在一项包括有症状和无症状的感染者的2409名受试者大型研究中得到验证。该测试显示其测试正确识别的阳性样本的百分比和测试正确识别的阴性样本的百分比分别具有91.2%的灵敏度和99.3%的特异性。该研究还显示，在只有4.2%的人对病毒呈阳性的人群中，该测试的阴性预测值为99.6%，这意味着在低发病率地区，接受阴性测试结果的人可能真的是阴性，准确度颇高。在一项针对omicron变异体的后续临床研究中，该测试具有相似的灵敏度。

美国相关部门已经发布首个COVID-19诊断测试仪的紧急使用授权，专业熟练的人员在可允许范围内使用该设备进行检测，仅需3min就能得到结果。

创新关键点

在已有渠道基础上思考新方法，利用呼吸研发疫情检测新方式。

Detecting the new crown by breathing, the breath analyzer innovates the new crown detection method

Both nasopharyngeal swab samples and antigen testing currently have their own shortcomings. The InspectIR COVID-19 breath analyzer can be tested directly by professionals in doctors' offices, hospitals and mobile testing sites through breath samples, using gas chromatography- Gas mass spectrometry (GC-MS) technology separates and identifies chemical mixtures and rapidly detects five volatile organic compounds (VOCs) associated with SARS-CoV-2 infection in exhaled breath.
When the InspectIR COVID-19 Breath Analyzer detects the presence of VOC markers for SARS-CoV-2, it returns a presumptive (unconfirmed) positive test result, confirmed by molecular testing. Negative results are considered in conjunction with the patient's recent medical history, exposure, and the presence of clinical signs and symptoms consistent with COVID-19. Therefore, it cannot simply be used as the sole basis for treatment, patient management decisions, or infection control decisions.
Its performance was validated in a large study of 2409 subjects including symptomatic and asymptomatic infected individuals. The test showed a sensitivity of 91.2% and a specificity of 99.3% for the percentage of positive samples it tested correctly identified and the percentage of negative samples it tested correctly identified, respectively. The study also showed that the test had a negative predictive value of 99.6 percent in a population where only 4.2 percent of people tested positive for the virus, meaning that in low-incidence areas, people who received a negative test result could actually be negative, Accuracy is quite high. In a follow-up clinical study of omicron variants, the test had similar sensitivity.
The FDA has issued an emergency use authorization for the first COVID-19 diagnostic tester, and professional and skilled personnel can use the device within the allowable range to test, and the results can be obtained in just 3 minutes.