Fever
Conditions
Brief summary
This study evaluates the clinical accuracy of the welloStationX, an automated non-touch self-service electronic thermometer using an infrared sensor of the surface of the forehead to screen for fever.
Detailed description
Traditionally, body temperature is measured using a contact thermometer placed on the forehead, in the mouth, ear, armpit or rectum. Non-contact thermometers allow a person's temperature to be taken with no contact with the person, reducing the discomfort of having to sit still for several minutes. Additionally, there is no need for disinfection between patients to occur, allowing for easier and faster use when screening large numbers of people. This study is to evaluate the clinical accuracy of the welloStationX, a non-contact thermometer by comparing its measurements with that of the gold standard Welch Allyn SureTemp oral thermometer.
Interventions
DIAGNOSTIC_TESTwelloStationX
welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.
DIAGNOSTIC_TESTSureTemp
SureTemp is an oral thermometer to measure human body skin temperature.
Sponsors
Wello Inc.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
5 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Male or female. * 5 years and up. * Signed informed consent form.
Exclusion criteria
* Use of medications known to affect body temperature (for example, antipyretics, barbiturates, thyroid preparations, antipsychotics, etc.) within 3 hours of the test. * immunization within seven days of the test
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Agreement Through Clinical Bias Evaluation | one day | Agreement through clinical bias evaluation was calculated as the Mean Bias ± Standard Deviation (SD) by subtracting the first output measurement recorded with the welloStationX thermometer (DUT) from the corresponding output measurement recorded with the Welch Allyn SureTemp oral thermometer for each subject, and then calculating the Mean Bias ± SD of the biases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Repeatability | one day | Clinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Temperature Measurement welloStationX: welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.
SureTemp: SureTemp is an oral thermometer to measure human body skin temperature. | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Temperature Measurement |
|---|---|
| Age, Continuous | 44.78 years STANDARD_DEVIATION 16.14 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 54 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| febrility afebrile subjects (temperature < 99.5 deg. C) | 77 Participants |
| febrility febrile subjects (temperature >=99.5 deg. C) | 33 Participants |
| Region of Enrollment United States | 110 Participants |
| Sex: Female, Male Female | 74 Participants |
| Sex: Female, Male Male | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 110 |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
Clinical Agreement Through Clinical Bias Evaluation
Agreement through clinical bias evaluation was calculated as the Mean Bias ± Standard Deviation (SD) by subtracting the first output measurement recorded with the welloStationX thermometer (DUT) from the corresponding output measurement recorded with the Welch Allyn SureTemp oral thermometer for each subject, and then calculating the Mean Bias ± SD of the biases.
Time frame: one day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Temperature Measurement | Clinical Agreement Through Clinical Bias Evaluation | 0.04 degrees Farehheit | Standard Deviation 0.42 |
Secondary
Clinical Repeatability
Clinical Repeatability was calculated using the pooled standard deviations of the triplicate measurements recorded by the welloStationX.
Time frame: one day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Temperature Measurement | Clinical Repeatability | 0.062 degrees Farehheit |