Prospective Clinical Evaluation of the BioFire Emerging Coronavirus Panel - Sponsor's Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,091
- 试验地点
- 12
- 主要终点
- Device Performance
研究概览
简要总结
The Biomedical Advanced Research and Development Authority (BARDA) has contracted BioFire Defense (BFDf) to develop the BioFire Emerging Coronavirus (ECoV) Panel, a nucleic acid test capable of detecting coronaviruses from nasopharyngeal swab (NPS) in transport medium.
This study aims to evaluate the diagnostic accuracy of the assays comprising the BioFire ECoV Panel. It is hypothesized that the BioFire ECoV Panel assays will be highly sensitive and specific for the detection of the coronaviruses included on the panel.
详细描述
The primary objective of this observational, non-interventional study is to evaluate the diagnostic accuracy of the assays comprising the BioFire ECoV Panel when used to test NPS obtained from individuals with signs and/or symptoms of respiratory infection. Multiple geographically distinct clinical sites in the U.S. will participate in testing. Enrollment will consist of residual, coded NPS specimens leftover from standard of care testing for a suspected respiratory infection as determined by a health care provider. Concordance between the BioFire ECoV Panel assays and comparator methods will be measured using positive and negative percent agreement (PPA and NPA).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Specimen is residual NPS in transport medium (VTM or UTM) left over from standard of care testing under clinician order for respiratory pathogen analysis.
- •Specimen has been held at room temperature for less than or equal to 4 hours or 4°C for less than or equal to 72 hours before enrollment.
- •At least 1.7 mL of specimen is remaining after standard of care testing and available for use in the study
排除标准
- •Specimen is unable to be tested within the defined storage parameters
- •Insufficient specimen volume for testing
- •Transport medium type is unknown
结局指标
主要结局
Device Performance
时间窗: Through study completion; September 2025-August 2026
Positive Percent Agreement and Negative Percent Agreement for Panel Targets
次要结局
未报告次要终点