2021 FDA Science Forum
Clinical Assessment of Non-Contact Infrared Thermometers as a Medical Countermeasure
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Contributing OfficeCenter for Devices and Radiological Health
Abstract
Background
Non-contact infrared thermometers (NCITs) are widely used during disease outbreaks as a temperature-measurement tool for screening the general public, travelers at ports of entry, and isolating patients in healthcare and other settings.
Methods
A clinical study was conducted with 1113 adult subjects using six different commercially available NCIT models to assess their temperature measurement accuracy. A total of 60 NCITs were tested with 10 units for each model. The NCIT-measured temperature was compared with the oral reference temperature.
Results
The mean difference between the oral reference thermometer and NCIT measurement (clinical bias) was different for each NCIT model. The clinical bias ranged from just under -0.9 °C (under-reporting) to just over +0.2 °C (over-reporting). The majority of the individual measurement differences ranged between -2 °C and +1 °C with extreme cases ranging from -3 °C to +2 °C. Depending upon the NCIT model, 48% to 88% of the individual temperature measurements were outside the labeled accuracy stated by the manufacturers. The sensitivity, which ranges from 0 (no detection) to 1 (ideal detection), of the NCIT models for detecting a subject’s temperature above 38 °C ranged from 0 to 0.69.
Conclusions
Overall, our results indicated that the tested NCIT devices may not be consistently accurate enough to determine if a subject’s temperature exceeds a specific threshold (e.g., 38 °C). Inter-model variability and intra-model accuracy of the displayed temperature were found to be outside of acceptable limits. Accuracy and credibility of NCITs should be more thoroughly investigated in future studies before considering them as an effective screening tool. The findings and conclusions in this study have not been formally disseminated by the Food and Drug Administration and should not be construed to represent any Agency determination or policy. Funding for this study was provided by FDA’s Medical Countermeasures Initiative.
