CSP0010 FINDER® Instrument and FINDER® FLU A/B, RSV, SARS-CoV-2 Test Clinical Evaluation Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes)
研究概览
简要总结
The goal of this observational study is to compare the FINDER FLU A/B, RSV, SARS-CoV-2 Test to an FDA-cleared device. The study will utilize prospectively collected de-identified nasopharyngeal samples obtained from both pediatric and adult populations from subjects presenting with symptoms of respiratory illness.
The main question it aims to answer are:
• the study is to validate that the device intended use in terms that the device's performance meets the criteria for substantial equivalence with a predicate and satisfies the statutory criteria for Clinical Laboratory Improvement Amendments (CLIA) waiver.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Nasopharyngeal samples will be collected using swabs and placed in liquid transport media.
- •The samples are obtained from individuals exhibiting respiratory signs and symptoms.
- •These samples are collected as part of standard differential diagnostic procedures.
- •A minimum sample volume of 1.5 mL is required for testing purposes.
排除标准
- •de-identified samples that have not been stored in accordance with CDC recommendations for nasopharyngeal (NP) sample storage.
- •Samples obtained from subjects who do not exhibit signs or symptoms of respiratory illness.
- •The sample with a volume is less than 1.5 mL
结局指标
主要结局
Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes)
时间窗: within 72 hours of collection of NP swab
Qualitative detection of viral RNA from Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2), Influenza A (H1N1 and H3N2 subtypes), Influenza B (Victoria and Yamagata strains), and Respiratory Syncytial Virus (A and B subtypes) in nasopharyngeal (NP) specimens from individuals suspected of respiratory tract infection by their healthcare provider.for adults and pediatrics when compared to a known FDA cleared assay/ instrument combination.
次要结局
- CLIA Waived results and clinical laboratory result(within 72 hours of collection of NP swab)