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FDA通知内容公开有关雅培的ID现在点护理测试可能的准确性问题

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ID现在

周三,5月14日,FDA提醒公众暗示使用雅培ID现在点护理测试来诊断covid-19潜在的不准确的结果早期数据。具体而言,测试可以返回假阴性结果。

“我们仍在评估有关结果不准确的信息,并与雅培这个重要问题进行直接沟通。We will continue to study the data available and are working with the company to create additional mechanisms for studying the test,” said Tim Stenzel, MD, PhD, director of the Office of In Vitro Diagnostics and Radiological Health in FDA’s Center for Devices and Radiological Health. “This test can still be used and can correctly identify many positive cases in minutes. Negative results may need to be confirmed with a high-sensitivity authorized molecular test.”

FDA正在共享可用约在透明的精神潜能的结果不准确的早期信息。The agency has been working with Abbott to analyze the information gathered to date and has worked with the company on a customer notification letter to alert users that any negative test results that are not consistent with a patient’s clinical signs and symptoms or necessary for patient management should be confirmed with another test.

FDA查看各种来源,以确定和了解潜在的模式或使用雅培试验的重大问题。由于性能特征、样本处理或用户错误,没有任何诊断测试是100%准确的,这就是为什么研究模式和确定可疑错误结果的原因很重要,这样任何重大问题都可以快速得到解决。

该机构意识到,已经确定了与雅培ID现在的精度问题,正在调查他们是否可能是由于该类型的使用棉签或病毒传输介质的类型,一些科学研究(材料用于运送病人的标本)。While there is important information to gather from these studies, it should be noted these studies have limitations, including small sample size, potential design biases, or tests that may not have been executed according to the manufacturer’s instructions for use, an important part of scientific research. This is why external scientific studies are one part of FDA’s overall evaluation of a diagnostic’s performance.

FDA已收到的有关雅培ID现在设备15个的不良事件报告,提出了一些用户收到不准确的阴性结果。该机构正在审查这些报告。It’s important to note that the adverse event reports FDA receives from manufacturers, healthcare providers, healthcare facilities, and patients can be incomplete, inaccurate, or unverified, so agency staff must meticulously comb through the reports to identify crucial data to support any signals or patterns about device use.

展望未来,雅培公司已同意开展上市后研究的ID现在设备,每个将包括至少150 covid-19在各种临床设置阳性患者。FDA将继续审查在现有基础上临时数据。从上市后研究中收集的信息可以进一步帮助该机构了解的任何准确性问题的原因或模式,并告知其他任何操作,该公司或FDA应该采取。

FDA将继续与雅培公司合作,以进一步评估这些准确性问题,将公开交流的任何更新。

消费者或医疗保健提供者可以直接在(224)667-6100,或通过电子邮件,在达到雅培www.abbott.com/contactus.html

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