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Zeteo Tech's test would collect breath samples from a ventilator such as the one above to detect respiratory infections.
Zeteo Tech的测试将从上述呼吸机中采集呼吸样本,以检测呼吸道感染。
NEW YORK – By capturing and identifying biological particles in exhaled breath, Zeteo Tech plans to bring to market tests to identify within about two hours whether patients have lower respiratory tract infections and aid decisions whether to start antimicrobial treatments.
纽约——Zeteo Tech计划通过捕获和识别呼出气中的生物颗粒,在大约两小时内将测试推向市场,以确定患者是否患有下呼吸道感染,并帮助决定是否开始抗菌治疗。
The Maryland-based biodefense and medical device firm has been developing a testing system that uses breath samples that are collected from a ventilator or CPR-type mask. Then leveraging mass spectrometry, a user can identify protease biomarkers of infections including early-stage infections in asymptomatic patients.
这家总部位于马里兰州的生物防御和医疗设备公司一直在开发一种测试系统,该系统使用从呼吸机或CPR型面罩收集的呼吸样本。然后利用质谱法,用户可以识别感染的蛋白酶生物标志物,包括无症状患者的早期感染。
Company officials recently reported in PNAS Nexus that they used the techniques in a proof-of-concept study to detect the increased release of human neutrophil elastase (HNE) from intubated patients who had ventilator-associated pneumonia..
公司官员最近在PNAS Nexus上报道称,他们在一项概念验证研究中使用了该技术,以检测呼吸机相关性肺炎插管患者的人中性粒细胞弹性蛋白酶(HNE)释放增加。。
While the company's initial tests will not be used to identify the type of pathogen that is causing an infection, company officials said that clinicians can still use the results to aid decisions whether to begin antibiotic treatments by helping them to determine earlier whether a patient has an active infection.
虽然该公司的初步检测不会用于确定引起感染的病原体类型,但该公司官员表示,临床医生仍然可以通过帮助他们尽早确定患者是否患有活动性感染来帮助决定是否开始抗生素治疗。
They noted that ventilator-associated infections, for example, are likely to be caused by bacteria..
他们指出,例如,呼吸机相关感染很可能是由细菌引起的。。
In an award abstract for a $967,000 Small Business Innovation Research grant from the National Science Foundation, the company said that short-course antibiotic therapies are typically used to treat patients following the diagnosis of lower respiratory tract infection, but current tests, including PCR assays, are unable to distinguish between colonization and infection.
在美国国家科学基金会(National Science Foundation)967000美元小企业创新研究资助的奖项摘要中,该公司表示,短程抗生素疗法通常用于治疗诊断为下呼吸道感染的患者,但目前的检测,包括PCR检测,无法区分定植和感染。
The company intends to use its technologies to aid the diagnosis of infections as well as predict the risk that patients will develop infections..
该公司打算利用其技术来帮助诊断感染,并预测患者感染的风险。。
'Our work would largely assist decision-making for clinicians regarding antibiotic treatment and dramatically improve patients' clinical outcomes by limiting antibiotic treatments and minimizing harmful exposure to unnecessary antibiotic treatment,' the company said in the SBIR grant.
该公司在SBIR拨款中表示:“我们的工作将在很大程度上帮助临床医生做出抗生素治疗的决策,并通过限制抗生素治疗和最大程度地减少不必要的抗生素治疗的有害暴露,大大改善患者的临床结果。”。
In the PNAS Nexus article, the authors reported that their quantitative test for HNE as a biomarker of lower respiratory tract infection achieved area under the receiver operating characteristic curve of 0.987 with a sensitivity of 1 and a specificity of 0.867.
在PNAS Nexus文章中,作者报告说,他们对HNE作为下呼吸道感染生物标志物的定量测试在受试者工作特征曲线下的面积为0.987,灵敏度为1,特异性为0.867。
Mike McLoughlin, Zeteo Tech chief technology officer, said the company's BreathBiomics sample collection device is used to capture proteins and peptides from the breath of intubated patients in about one hour. The same device, however, also could be used to collect samples from patients in an ambulance in about five to 10 minutes because of the higher flow rate of patient breaths under those conditions..
。然而,同样的设备也可以用于在大约5到10分钟内从救护车上的患者身上采集样本,因为在这种情况下患者的呼吸流速更高。。
'It's well established that earlier intervention with antibiotics is helpful. However, there's great concern over overuse of antibiotics,' McLoughlin said. 'So, what they're really looking for is a better tool set so that they can, number one, detect an active infection early.'
“众所周知,早期使用抗生素干预是有帮助的。然而,麦克劳林说,抗生素的过度使用令人担忧因此,他们真正想要的是一个更好的工具集,以便他们能够尽早发现活动性感染。”
The sample collection system leverages chemical affinity to capture biological targets. In the recent study, the collection column was attached to the ventilator exhaust tubing of critical care patients at Johns Hopkins Hospital in Baltimore and integrated into a CPR-use face mask for the collection of samples from healthy volunteers.
样品采集系统利用化学亲和力捕获生物靶标。在最近的研究中,收集柱连接到巴尔的摩约翰·霍普金斯医院重症监护患者的呼吸机排气管上,并集成到CPR使用面罩中,用于从健康志愿者收集样本。
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McLoughlin said that the company extracted the captured particulate from a filter and mixed it with a sensor molecule. HNE was detected through a distinctive mass shift after a reaction between HNE and the sensor molecule caused the release of a reporter molecule, he said.
McLoughlin说,该公司从过滤器中提取捕获的颗粒,并将其与传感器分子混合。他说,在HNE和传感器分子之间的反应导致报告分子释放后,通过独特的质量变化检测到HNE。
The researchers reported that their approach allowed the detection of ultralow protease concentrations through mass spectrometry, while McLoughlin noted that the methods used in the study also could be applied to the development of multiplex tests with sensor molecules for multiple proteases.
研究人员报告说,他们的方法可以通过质谱法检测超低蛋白酶浓度,而McLoughlin指出,该研究中使用的方法也可以应用于开发多种蛋白酶传感器分子的多重测试。
While the company's focus has been on lower respiratory tract infections, he said that the technology has the potential for a wider range of applications.
虽然该公司专注于下呼吸道感染,但他表示,该技术具有更广泛应用的潜力。
'Even if you're not on a ventilator, you're still going to be expressing those molecules, so we think that there's great applicability for not only detecting lung infections but, ultimately, for things like managing [chronic obstructive pulmonary disease], asthma, and other chronic lung diseases where inflammation response is a major indicator that there's a potential issue,' he said..
他说:“即使你没有使用呼吸机,你仍然会表达这些分子,因此我们认为,不仅可以检测肺部感染,而且最终可以用于治疗(慢性阻塞性肺病)、哮喘和其他炎症反应是潜在问题的主要指标的慢性肺病。”。。
Zeteo Tech CEO Wayne Bryden said the firm plans to assess which of the dozens of other proteases that are expelled in breath could be used to assess the response to infection or provide more information about the health of a patient's lungs. Dapeng Chen, principal investigator on the recent study, said that some of those proteases may help to differentiate between viral, bacterial, and fungal infections, while Bryden said that some could be used to distinguish between infections with Gram-positive and Gram-negative bacteria, identify bacterial species, or provide information that could be used to predict drug resistances..
Zeteo Tech首席执行官韦恩·布莱登(WayneBryden)表示,该公司计划评估呼吸中排出的数十种其他蛋白酶中,哪些可用于评估对感染的反应或提供有关患者肺部健康的更多信息。最近这项研究的首席研究员陈大鹏(Dapeng Chen)表示,其中一些蛋白酶可能有助于区分病毒,细菌和真菌感染,而布莱登(Bryden)表示,一些蛋白酶可用于区分革兰氏阳性菌和革兰氏阴性菌的感染,鉴定细菌种类,或提供可用于预测耐药性的信息。。
Meanwhile, Bryden said that the confirmation that a patient has an infection also could trigger the use of a PCR assay or culture-based test to determine the causes of infection.
与此同时,布莱登说,确认患者感染也可能引发使用PCR检测或基于培养的检测来确定感染原因。
Albert Rizzo, chief medical officer of the American Lung Association, said that a diagnosis of lower respiratory tract infection is typically reached through the assessment of clinical presentation such as coughing, sputum production, and shortness of breath along with physical examination and, often, a chest X-ray.
美国肺协会首席医疗官阿尔伯特·里佐(AlbertRizzo)表示,下呼吸道感染的诊断通常是通过评估临床表现,如咳嗽、痰液产生和呼吸急促,以及体格检查和胸部X光检查来实现的。
While monitoring intubated patients in an ICU, doctors may have to decide whether the shadows and other visual changes that they see on radiographs are infections that require treatment, and he noted that the recent study results suggest that elevated HNE release is correlated with active infection..
在ICU监测插管患者时,医生可能必须确定他们在X光片上看到的阴影和其他视觉变化是否是需要治疗的感染,他指出,最近的研究结果表明,HNE释放升高与活动性感染有关。。
Rizzo, who is not connected with Zeteo Tech or the company's research, said that tests that can help to more closely determine the cause of the infection are going to help healthcare providers to tailor antibiotic treatments to patients earlier rather than after starting them on empirical treatments.
Rizzo与Zeteo Tech或该公司的研究无关,他说,可以帮助更密切地确定感染原因的测试将有助于医疗保健提供者尽早为患者量身定制抗生素治疗,而不是在开始经验性治疗后。
He noted that treatment plans are typically developed through the evaluation of a combination of factors including whether the patient is in an outpatient or inpatient setting, whether they are hospitalized in the ICU, the severity of disease, and their recent medical history. Diagnostic tests may be used to distinguish whether a patient who develops pneumonia during cold and flu season, for example, has a viral or bacterial infection..
他指出,治疗计划通常是通过评估多种因素制定的,这些因素包括患者是在门诊还是住院,他们是否在ICU住院,疾病的严重程度以及他们最近的病史。例如,诊断测试可用于区分在感冒和流感季节患肺炎的患者是否患有病毒或细菌感染。。
McLoughlin said that Zeteo Tech has requested a pre-submission meeting with the US Food and Drug Administration, although the company remains early in its regulatory and commercialization processes. He said the company, though, is already experienced at building small and robust mass spectrometers and tests through its prior biodefense contracts..
McLoughlin表示,Zeteo Tech已要求与美国食品和药物管理局举行提交前会议,尽管该公司仍处于监管和商业化进程的早期阶段。他说,尽管如此,该公司已经通过其先前的生物防御合同在制造小型和强大的质谱仪和测试方面拥有丰富经验。。
Zeteo Tech announced late last year that the US Department of Homeland Security had awarded the company an SBIR Phase III contract for at least $1.9 million and up to $5.9 million for the development and testing of its DigitalMALDI sensor technology that is used for the detection of dangerous aerosolized biological agents including bacteria, viruses, and toxins..
Zeteo Tech去年年底宣布,美国国土安全部已授予该公司SBIR第三阶段合同,合同金额至少为190万美元,最高为590万美元,用于开发和测试其DigitalMALDI传感器技术,该技术用于检测危险的雾化生物制剂,包括细菌、病毒和毒素。。
Bryden noted that the company's previous work also includes Bill and Melinda Gates Foundation-funded research in South Africa on the use of the company's technology to detect tuberculosis through breath samples and mass spectrometry.
布莱登指出,该公司之前的工作还包括比尔和梅琳达·盖茨基金会在南非资助的研究,该研究利用该公司的技术通过呼吸样本和质谱检测结核病。
As for the company's BreathBiomics technology, Bryden said that the firm's analysis so far suggests that its breath-based tests have promising market potential, and it is gathering additional data to continue developing its commercialization plans.
至于该公司的呼吸生物技术,布莱登表示,该公司迄今为止的分析表明,其基于呼吸的测试具有广阔的市场潜力,并且正在收集更多数据,以继续制定其商业化计划。
'We are working as hard as we can to try to figure that out and to move forward,' he said.
他说,我们正在尽最大努力解决这个问题并取得进展。