A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 3
- 主要终点
- Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
研究概览
简要总结
The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens.
The objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.
详细描述
The ARIES Flu Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.
The objective is to establish the diagnostic accuracy of ARIES Flu Assay through a multi-site, method comparison on prospectively collected, left-over, and de-identified, nasopharyngeal swab specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
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
- •The specimen is from a patient suspected of having respiratory tract infection for whom a requisition has been made for viral testing
- •The specimen is from a male of female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.
- •The specimen is a nasopharyngeal swab
排除标准
- •The specimen is NOT a nasopharyngeal swab
- •The specimen was not properly collected, transported or stored according to the instructions provided by the sponsor.
结局指标
主要结局
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
时间窗: Within the first year of sample collection
Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by ARIES Flu assay.
次要结局
未报告次要终点