Novel Point-of-Care Diagnostic Test for SARS-CoV-2 (COVID-19)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2

Conditions
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COVID-19 Infection

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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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
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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (biospecimen collection)<br>Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples. | Procedure: Biospecimen Collection<br>* Undergo collection of nasopharyngeal, oral, saliva, and nasal samples<br>Other: Questionnaire Administration<br>* Demographic information, sample collection type preferences; clinical outcome information<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 1 year | 
| Concordance of the novel point-of-care diagnostic test | Will be estimated with 95% confidence intervals. | Up to 1 year | 
| Positive predictive value (PPV) of the novel point-of-care diagnostic test | Will be estimated with 95% confidence intervals. | Up to 1 year | 
| Negative predictive value (NPV) of the novel point-of-care diagnostic test | Will be estimated with 95% confidence intervals. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | Up to 1 month |