SpotLight-19 Research & Development Study

Study Overview
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Brief Summary
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In this study, we will use the SpotLight-19 device in patients presenting to a coronavirus disease (COVID-19) Assessment Centre for polymerase chain reaction (PCR) testing. Consenting patients will undergo a Spotlight-19 scan. We will link the scan to PCR results, age, vaccination status, and COVID-19 symptoms in order to calibrate the SpotLight-19 prediction algorithm of a state of COVID-19 infection.

Detailed Description
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Implementation of rapid, accessible, and accurate COVID-19 testing is a cornerstone of public health efforts to contain and respond to the spreading virus. To respond to this need, ISBRG Corp is applying its SpotLight-19 device to the challenge of developing a non-invasive screening test for COVID-19. The SpotLight-19 device is designed to use non-invasive visible and near-infrared (NIR) spectroscopic measurements of an individual's fingertip and an artificial intelligence technology platform calibrated using viral diagnostic measurements to identify and recognize a spectral fingerprint specific to COVID-19. All individuals (3yrs or older) presenting to designated hospital COVID-19 Assessment Centres in Ottawa will be recruited to participate. Only people with extreme fingertip scarring will be excluded. Consenting participants will undergo a scan using the SpotLight-19 device - this includes a Fitzpatrick Skin Assessment and 10-20 second scans of the fingertip with the SpotLight-19 device. Following the scan participants will undergo a PCR test as per usual care. The PCR result, participant age, COVID-19 vaccination status, and presence of COVID-19 symptoms will be collected from the medical record and shared with ISBRG Corp. A minimum of 250 COVID-19 positive and a minimum of 250 COVID-19 negative as determined by PCR will be sought. The number of enrolled participants to achieve the sample size will depend on the COVID-19 positivity rate.

Official Title
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SpotLight-19 Research and Development Study

Conditions
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Screening

Intervention / Treatment
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* Device: Spectral scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Qualifies for COVID-19 testing as per Assessment Site protocol; or Is capable of cooperating with testing Is clinically stable such that the testing protocol may be completed safely Exclusion Criteria: Extreme fingertip scarring or other physical condition that prevents use of the device

Ages Eligible for Study
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Minimum Age: 3 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Spectral scan (All participants)<br>Fitzpatrick skin assessment. Fingertip scanned using the SpotLight-19 device. The scan is approximately 10-20 seconds. Participants will not feel any sensation from the device, i.e., no heat, no pain, no cold, no vibration or pressure. Information collected from the medical record regarding participant age, COVID-19 vaccination status, presence of COVID-19 symptoms, and PCR test result. | Device: Spectral scan<br>* Consenting participants will have a SpotLight-19 scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| spectra indicative of COVID-19 infection | specific wavelengths of light that correlate with COVID-19 infection | immediate upon scan |