SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), has negatively impacted global health and requires more research to develop better tests and to improve disease treatment. The purpose of this research is to aid in the testing effort by collecting samples from people who have been diagnosed with COVID-19 or are suspected of having COVID-19. Samples you provide will be used investigationally by INanoBio to develop a test to determine when antibodies against various SARS-CoV-2 proteins are detectable. Up to approximately 80 subjects of all ages with either a suspected or lab-confirmed diagnosis of COVID-19 will take part in this research.
A longitudinal, non-randomized study to evaluate the utility of the INanoBio's protein arrays
in detecting unique antibodies in COVID-19 patients. To study the feasibility of utilizing a
viral proteome microarray for evaluating exposure status, immunity status, diagnosis, and
prognosis of SARS-CoV-2 infections during and after the course of disease. The sample size is
to include 80 subjects: 40 diagnosed with COVID-19 and 40 suspected to have COVID-19. The
goal will be to assess antibodies throughout the subject's disease course compared to
controls.
Diagnostic Test: Sampling
Test is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins.
Inclusion Criteria:
Subject must meet all of the following criteria to be eligible for treatment in the study:
1. Subject or legal representative understands the nature of the procedure and has signed
the Subject Informed Consent Form prior to study procedures
2. For the COVID-19 Cohort
- Subject has lab-confirmed diagnosis of COVID-19 by RT-PCR
3. For the PUI Cohort
- Subject has suspected COVID-19 according to medical evaluation, but does not yet
have lab-confirmed diagnosis of COVID-19 (results outstanding, or has tested
negative by RT-PCR)
Exclusion Criteria:
- Subject or legal representative not willing to consent
TMC HealthCare
Tucson, Arizona, United States
Investigator: Natalia Elias Calles, MPH
Natalia Elias Calles, MPH
5203275461
Research@tmcaz.com
Katherine Scott, Principal Investigator
TMC HealthCare