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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
257
Undergo collection of nasopharyngeal, oral, saliva, and nasal samples
Demographic information, sample collection type preferences; clinical outcome information
Lyndon Baines Johnson General Hospital
Houston, Texas, United States
M D Anderson Cancer Center
Houston, Texas, United States
Sensitivity of diagnostic test
Will use the standard-of-care (real time polymerase chain reaction \[RT-PCR\]) coronavirus disease 19 (COVID-19) test at the MD Anderson Molecular Diagnostic Lab result for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as the true result to estimate sensitivity with 95% confidence intervals. Estimates of sensitivity and specificity of the novel point-of-care diagnostic test will be provided separately for the provider-collected nasopharyngeal samples, the self-collected nasal swab, and the self-collected cheek swab.
Time frame: Up to 1 year
Specificity of diagnostic test
Will use the standard-of-care (RT-PCR) COVID-19 test at the MD Anderson Molecular Diagnostic Lab result for SARS-CoV-2 as the true result to estimate specificity with 95% confidence intervals. Estimates of sensitivity and specificity of the novel point-of-care diagnostic test will be provided separately for the provider-collected nasopharyngeal samples, the self-collected nasal swab, and the self-collected cheek swab.
Time frame: Up to 1 year
Concordance of the novel point-of-care diagnostic test
Will be estimated with 95% confidence intervals.
Time frame: Up to 1 year
Positive predictive value (PPV) of the novel point-of-care diagnostic test
Will be estimated with 95% confidence intervals.
Time frame: Up to 1 year
Negative predictive value (NPV) of the novel point-of-care diagnostic test
Will be estimated with 95% confidence intervals.
Time frame: Up to 1 year
Viral load metrics
Will use descriptive statistics to summarize viral load metrics from the standard-of-care (RT-PCR) SARS-CoV-2 test and from each of the point-of-care tests.
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Time frame: Up to 1 month
Disease progression
Will use logistic regression methods to model progression to severe disease (defined as hospitalization) as a function of viral load, age, gender, smoking history, comorbidities, and symptoms for each of these tests.
Time frame: Up to 1 month