Evaluation of a Novel Point-of-Care Diagnostic Test for SARS-CoV-2
试验速览
- 阶段
- 不适用
- 入组人数
- 257
- 试验地点
- 2
- 主要终点
- Sensitivity of diagnostic test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Patient or provider decision not to perform SARS-CoV-2 testing
研究组 & 干预措施
Diagnostic (biospecimen collection)
Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples.
干预措施: Biospecimen Collection (Procedure)
Diagnostic (biospecimen collection)
Participants undergo collection of nasopharyngeal (back of the nose) samples by a medical provider and self-collection of oral, saliva, and nasal samples.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Sensitivity of diagnostic test
时间窗: Up to 1 year
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.
Specificity of diagnostic test
时间窗: Up to 1 year
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.
Concordance of the novel point-of-care diagnostic test
时间窗: Up to 1 year
Will be estimated with 95% confidence intervals.
Positive predictive value (PPV) of the novel point-of-care diagnostic test
时间窗: Up to 1 year
Will be estimated with 95% confidence intervals.
Negative predictive value (NPV) of the novel point-of-care diagnostic test
时间窗: Up to 1 year
Will be estimated with 95% confidence intervals.
次要结局
- Viral load metrics(Up to 1 month)
- Disease progression(Up to 1 month)