Clinical Evaluation of Non-Contact Infrared Thermometers

dc.contributor.authorSullivan, Stacey J.L.
dc.contributor.authorRinaldi, Jean E.
dc.contributor.authorHariharan, Prasanna
dc.contributor.authorCasamento, Jon P.
dc.contributor.authorBaek, Seungchul
dc.contributor.authorSeay, Nathanael
dc.contributor.authorVesnovsky, Oleg
dc.contributor.authorTopoleski, Timmie
dc.date.accessioned2021-09-15T17:04:04Z
dc.date.available2021-09-15T17:04:04Z
dc.date.issued2021-08-18
dc.description.abstractBackground: Non-contact infrared thermometers (NCITs) are being widely used during the COVID-19 pandemic as a temperature-measurement tool for screening and isolating patients in healthcare settings, travelers at ports of entry, and the general public. Methods: To understand the accuracy of NCITs, a clinical study was conducted with 1113 adult subjects using six different commercially available NCIT models. A total of 60 NCITs were tested with 10 units for each model. The NCIT-measured temperature was compared with the oral temperature obtained using a reference oral thermometer. Results: The mean difference between the 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 individual differences ranged from -3 °C to +2 °C in extreme cases, with the majority of the differences between -2 °C and +1 °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 of the NCIT models for detecting subject’s temperature above 38 °C ranged from 0 to 0.69. Conclusions: Overall, our results indicate that some NCIT devices may not be consistently accurate enough to determine if subject’s temperature exceeds a specific threshold of 38 °C. Model-to-model variability and individual model accuracy in the displayed temperature were found to be outside of acceptable limits. Accuracy and credibility of the NCITs should be thoroughly evaluated before using them as an effective screening tool.en_US
dc.description.sponsorshipThe authors gratefully acknowledge the contributions of Dr. Quanzeng Wang (FDA/CDRH), who organized and led the clinical study; Dr. Pejman Ghassemi (FDA/CDRH), who helped with the oral thermometer evaluation and clinical data collection; Dr. David McBride, former director of the University Health Center of the University of Maryland and his staff for their outstanding cooperation, especially Peter Tan, Monica Chu, Peter Chin, Pooneh Azadikhah, Oluwatobi Fagbohun, Shira Winston, Jacqueline Dempsey, Muzammil Quadir, Madison Varvaris and Raqel Pryor for their assistance with data collection.en_US
dc.description.urihttps://www.researchsquare.com/article/rs-802048/v1en_US
dc.format.extent16 pagesen_US
dc.genrejournal articlesen_US
dc.genrepreprintsen_US
dc.identifierdoi:10.13016/m2ginl-enoo
dc.identifier.citationSullivan, Stacey J.L. et al.; Clinical Evaluation of Non-Contact Infrared Thermometers; Scientific Reports, 18 August, 2021; https://doi.org/10.21203/rs.3.rs-802048/v1en_US
dc.identifier.urihttps://doi.org/10.21203/rs.3.rs-802048/v1
dc.identifier.urihttp://hdl.handle.net/11603/22986
dc.language.isoen_USen_US
dc.publisherResearch Squareen_US
dc.relation.isAvailableAtThe University of Maryland, Baltimore County (UMBC)
dc.relation.ispartofUMBC Mechanical Engineering Department Collection
dc.relation.ispartofUMBC Faculty Collection
dc.relation.ispartofUMBC Student Collection
dc.relation.ispartofUMBC Mathematics and Statistics Department
dc.rightsThis item is likely protected under Title 17 of the U.S. Copyright Law. Unless on a Creative Commons license, for uses protected by Copyright Law, contact the copyright holder or the author.en_US
dc.rightsAttribution 4.0 International (CC BY 4.0)*
dc.rights.urihttps://creativecommons.org/licenses/by/4.0/*
dc.titleClinical Evaluation of Non-Contact Infrared Thermometersen_US
dc.typeTexten_US

Files

Original bundle

Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
34c8e96d-ecbf-431f-8307-33527f1e916a.pdf
Size:
633.26 KB
Format:
Adobe Portable Document Format
Description:

License bundle

Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
license.txt
Size:
2.56 KB
Format:
Item-specific license agreed upon to submission
Description: