Significance: 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.
Aim: Perform controlled nonhuman trials of IRT devices to identify and quantify deviations in the human temperature range.
Approach: 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.
Results: 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.
Conclusion: 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.
Keywords: IRT; NCIT; febrility; pyrometry; screening; thermography.