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Clinical evaluation of non-contact infrared thermometers.
Sullivan, Stacey J L; Rinaldi, Jean E; Hariharan, Prasanna; Casamento, Jon P; Baek, Seungchul; Seay, Nathanael; Vesnovsky, Oleg; Topoleski, L D Timmie.
  • Sullivan SJL; Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
  • Rinaldi JE; Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
  • Hariharan P; Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA. Prasanna.hariharan@fda.hhs.gov.
  • Casamento JP; Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
  • Baek S; University of Maryland Baltimore County, Baltimore, MD, USA.
  • Seay N; University of Maryland Baltimore County, Baltimore, MD, USA.
  • Vesnovsky O; Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
  • Topoleski LDT; Division of Applied Mechanics, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, United States Food and Drug Administration, 10903 New Hampshire Ave, Silver Spring, MD, 20993, USA.
Sci Rep ; 11(1): 22079, 2021 11 11.
Article in English | MEDLINE | ID: covidwho-1510625
ABSTRACT
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. 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. 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 to + 2 °C in extreme cases, with the majority of the differences between - 2 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. 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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thermometers / Fever / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Adult / Female / Humans / Male / Young adult Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-99300-1

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Thermometers / Fever / COVID-19 Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Adult / Female / Humans / Male / Young adult Language: English Journal: Sci Rep Year: 2021 Document Type: Article Affiliation country: S41598-021-99300-1