Performance Evaluation of the Lucira COVID-19 & Flu Test Versus FDA Authorized SARS-CoV-2 and Influenza A&B Assays
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,361
- 试验地点
- 12
- 主要终点
- Confirmation That the Lucira COVID-19 & Flu Test Provides Similar Performance to a High Complexity Lab Molecular Diagnostic RT-PCR Assay(s) With Known High Sensitivity
研究概览
简要总结
The Lucira COVID-19& Flu Test is a single use (disposable) RT-LAMP test kit intended for the simultaneous rapid in vitro qualitative detection and differentiation of SARS-CoV-2, Influenza A, and Influenza B viral RNA in anterior nasal swab specimens.
The test consists of a nasal swab, a sample vial the nasal swab sample is placed in the sample vial, containing the sample buffer, and the test unit, which detects whether SARS-CoV-2, Influenza A, and Influenza B virus is present within the specimen during an acute infection. The Lucira test uses a proprietary, molecular based process to detect the presence of SARS-CoV-2, Influenza A, or Influenza B virus. The purpose of this study is to investigate the Lucira COVID-19 & Flu Test for the in vitro qualitative detection and differentiation of RNA from SARS-CoV-2, Influenza A, and Influenza B in nasal swab specimens from patients suspected of COVID-19 or Influenza A or Influenza B. The primary objective is to test at least 1000 self-collected nasal swab samples and to confirm the Lucira COVID-19 & Flu Test provides similar accuracy to a high complexity lab molecular diagnostic RT-PCR assay(s) with known high sensitivity for detecting SARS-CoV-2, Influenza A, and Influenza B virus.
详细描述
The study is a prospective study with seven (7) sites in the U.S. participating in the study. The Investigational device was tested on-site, and the comparator samples were sent to reference laboratories in the U.S. Reference testing was performed by trained laboratory personnel. This investigational device testing was performed in a simulated-home environment with medical staff on site and included nasal swabs self-collected by study subjects per the quick reference instructions (QRI).
A qualified research person was designated as the Investigator at each site with the responsibility for oversight of the study in accordance with Good Clinical Practice (GCP) and regulatory requirements.
The protocol and subject informed consent were reviewed by an Institutional Review Board (IRB) and written IRB approval was issued prior to enrollment of subjects into the study at that site.
A subject's participation in this study consisted of a single visit. Following completion of the informed consent process and a review of Inclusion/Exclusion criteria to determine eligibility, each subject then received a unique study identification number. Subject demographics including age, sex, race, ethnicity, education level, employment status, and income was also collected at that time.
Two (2) swabs were collected for this study: One (1) nasal swab for the Lucira COVID-19 & Flu Test and one (1) nasal swab for reference testing. These two study swabs were both collected similarly as directed in the Lucira COVID-19 & Flu Test QRI. Any swab specimens required for routine standard of care testing were collected prior to the specimens collected for this investigation.
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
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 14 years and older (self-collected) or individuals less than 14 years old but ≥ 2 years old (collected by an adult)
- •Human subjects suspected of respiratory viral infection consistent with COVID-19 or Influenza by their healthcare provider within 4 days of symptom onset
- •Must be willing to try Lucira COVID-19 & Flu test with an anterior nasal (nasal) swab specimen collected from both nostrils
- •Subject information shall include: gender, age, collection date, collection time, race, ethnicity, temperature, signs/symptoms, date of symptom onset, symptom severity, vaccination status, household income, education status, employment status, routine test data (results, methodology, date of collection, if available)
排除标准
- •Currently suffering from nasal trauma such as a nosebleed
- •Received a nasal rinse/wash/aspirates for standard of care testing
- •The subject is undergoing treatment for COVID-19 or Flu currently and/or within the past 14 days of the study visit, including but not limited to: inhaled influenza vaccine (FluMist®) or flu antiviral medication, which may include but is not limited to Amantadine (Symmetrel®), Rimantadine (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir marboxil (Xofluza®).
- •The subject is currently receiving or has received within the past 30 days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
- •The subject has previously participated in this research study
- •Incorrect comparator swab type or transport media
- •Incorrect specimen handling
- •Subjects not consented
结局指标
主要结局
Confirmation That the Lucira COVID-19 & Flu Test Provides Similar Performance to a High Complexity Lab Molecular Diagnostic RT-PCR Assay(s) With Known High Sensitivity
时间窗: Day 1
The sensitivity and specificity endpoint are Percent Positive Agreement (PPA) ≥80%/Negative Positive Assessment (NPA) ≥98% for COVID-19 and PPA ≥90%/NPA ≥95% for Flu A\&B as compared to FDA emergency use authorized SARS-CoV-2 and FDA cleared Influenza A+B Assays. Two (2) swabs were collected for this study: One (1) anterior nasal swab (NS) for the Lucira COVID-19 and Flu Test and one (1) NS for reference testing. Reference testing characterized specimens as negative or positive for SARS-CoV-2 and Influenza A and B. Therefore, PPA and NPA of the Lucira COVID-19 and Flu Test were calculated by comparison with the respective reference methods. The data were analyzed via comparison to the comparator method in this protocol in a standard 2x2 table, with PPA and NPA calculated against the comparator. The percentage of the expected result was computed individually along with the associated 95% Wilson Score Confidence Interval \[1\] for each panel.
次要结局
未报告次要终点