IPVM, Bethlehem, Pennsylvania, United States.
Infrared Thermography for Febrile Screening in Public Health - ISBN-13: 978-3659263194.
J Biomed Opt. 2021 Mar;26(4). doi: 10.1117/1.JBO.26.4.043009.
The need for regulatory review of infrared thermographs (IRTs) used on humans was removed in response to the unique circumstances of the SARS-CoV-2 pandemic (a.k.a., COVID-19). The market for these devices has since expanded considerably. This evaluation of IRT performance may have significant implications for febrility screening worldwide.
Perform controlled nonhuman trials of IRT devices to identify and quantify deviations in the human temperature range.
We compared IRT readings of a temperature-controlled non-human subject with one FDA-cleared IRT and one FDA-cleared handheld NCIT. In individual trials for each device, the subject was measured between 35°C and 40°C at 0.25°C increments.
The IRT device measurements were consistently normalized around the human mean (∼37 ° C). Temperatures were decremented as they approached the febrile range, and systematically reported as normal across all seven devices. This effect does not appear to be explained by a fixed offset or any known approach to estimating body temperature, or by random error.
The IRTs in this study generated human temperature measurements that were systematically biased to the mean human temperature. Given that these devices are utilized for sentinel detection of possible infectious disease transmission, and are now globally employed, the implications for reduced detection of febrility are a widespread false sense of security. This vulnerability must be considered with respect to facility access control, clinical applications, and travel screening in the context of the ongoing COVID-19 pandemic response.
针对 SARS-CoV-2 大流行(又称 COVID-19)的特殊情况,取消了对人体红外热像仪(IRT)的监管审查要求。自此,这些设备的市场规模大幅扩大。这项对 IRT 性能的评估可能对全球发热筛查产生重大影响。
对 IRT 设备进行非人体受控试验,以确定和量化人体温度范围内的偏差。
我们将经过温度控制的非人体试验对象的 IRT 读数与一个获得 FDA 批准的 IRT 和一个获得 FDA 批准的手持 NCIT 进行了比较。在每个设备的单独试验中,在 0.25°C 的增量下,将试验对象在 35°C 至 40°C 之间进行测量。
IRT 设备的测量值始终围绕人体平均值(约 37°C)进行归一化。当接近发热范围时,温度会降低,并且所有七台设备均系统地报告为正常。这种效应似乎不是由固定偏移或任何已知的体温估计方法或随机误差引起的。
本研究中的 IRT 生成的人体温度测量值存在系统偏差,偏向于人体平均温度。鉴于这些设备用于探测可能的传染病传播的哨点,并且现在在全球范围内使用,因此降低对发热的检测可能会导致广泛的虚假安全感。在当前 COVID-19 大流行应对期间,必须考虑设施准入控制、临床应用和旅行筛查方面的这种脆弱性。