Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Test Results Comparison Between LumiraDx and GenScript
研究概览
简要总结
EPOC is designed to examine the feasibility of conducting two point-of-care (POC) tests the LumiraDx SARS-CoV-2 Antibody Test and the RightSign COVID-19 IgG/IgM Rapid Test for SARS-CoV-2 antibodies and compare the reproducibility of these tests to tests run at a central laboratory on specimens obtained from the same study participants at the same time.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Informed consent by the patient or the patient's legally authorized representative (LAR) for up to 4 fingersticks for POC testing and a blood draw for stored blood samples.
- •SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing within 3 days prior to consent OR documented by NAT or equivalent testing more than 3 days prior to consent AND progressive disease suggestive of ongoing SARS-CoV-2 infection per the responsible investigator. (For non-NAT tests, only those deemed with equivalent specificity to NAT by the protocol team will be allowed. A central list of allowed non-NAT tests is maintained for TICO and that list will also be used for this protocol.)
- •Duration of symptoms attributable to COVID-19 ≤ 12 days per the responsible investigator.
- •Requiring admission for inpatient hospital acute medical care for clinical manifestations of COVID-19, per the responsible investigator, and NOT for purely public health or quarantine purposes.
排除标准
- •Prior receipt of SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from COVID-19, or SARS-CoV-2 nMAb within 6 months of the blood draws for testing as part of this protocol.
- •Disease severity beyond that of stratum 1 in the TICO trial. This includes the following conditions:
- •encephalitis
- •myocardial infarction
- •myocarditis
- •pericarditis
- •symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] class III-IV)
- •arterial or deep venous thrombosis or pulmonary embolism
- •Current requirement for any of the following:
- •high-flow supplemental oxygen
- •non-invasive ventilation
- •invasive mechanical ventilation
- •extracorporeal membrane oxygenation
- •mechanical circulatory support
- •vasopressor therapy
- •commencement of renal replacement therapy at this admission (i.e., not patients on chronic renal replacement therapy).
- •In the opinion of the responsible investigator, any condition for which, participation would not be in the best interest of the participant or that could limit protocol specified assessments.
结局指标
主要结局
Test Results Comparison Between LumiraDx and GenScript
时间窗: an average of 1 day
LumiraDx test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.
Comparison of Results Obtained by RightSign and GenScript
时间窗: an average of 1 day
RightSign test and GenScript assay are two ways to determine the presence of antibodies to SARS-CoV-2. This measure is a comparison to check agreement between the two tests' results. This is a comparison of the proportion of the positive tests. The comparison is made by looking at the difference of the two proportions obtained by the two tests, so the measure is unitless.
次要结局
- LumiraDx Valid Test Frequency(an average of 1 day)
- RightSign Valid Test Frequency(an average of 1 day)