This study investigates a new diagnostic test in detecting SARS-CoV-2, the virus that causes the disease COVID-19. This may help to improve testing for COVID-19.
PRIMARY OBJECTIVE:
I. To evaluate the clinical performance of a novel point-of-care diagnostic test for
detecting severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes
the disease called coronavirus disease 19 (COVID-19).
SECONDARY OBJECTIVES:
I. To compare the clinical performance of provider-collected nasopharyngeal samples with
self-collected nasal swab, cheek swab, and saliva sample using the novel SARS-CoV-2
diagnostic test.
II. To measure viral load and evaluate the role of viral load in COVID-19 severity.
OUTLINE:
Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical
provider and self-collection of oral, saliva, and nasal samples.
After completion of study, participants are followed up at 1 month.
Procedure: Biospecimen Collection
Undergo collection of nasopharyngeal, oral, saliva, and nasal samples
Other: Questionnaire Administration
Demographic information, sample collection type preferences; clinical outcome information
Inclusion Criteria:
- Qualifies for SARS-CoV-2 testing at MD Anderson, Lyndon B. Johnson (LBJ) hospital, or
affiliated sites (may include MD Anderson and LBJ patients and employees) according to
institutional criteria at time of enrollment
- Willing and able to provide informed consent
- Ability to perform protocol-required activities
- Able to speak and read English or Spanish
Exclusion Criteria:
- Patient or provider decision not to perform SARS-CoV-2 testing
Lyndon Baines Johnson General Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Kathleen M Schmeler, Principal Investigator
M.D. Anderson Cancer Center