Clinical Performance Evaluation of the VitaSIRO Solo™ SARS-CoV-2/Flu/RSV Assay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,268
- 试验地点
- 1
- 主要终点
- Positive percent agreement(PPA) and Negative percent agreement (NPA)
研究概览
简要总结
The purpose of this clinical trial is to demonstrate the clinical performance of the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay in detecting SARS-CoV-2, Flu A, Flu B and RSV in symptomatic population. The primary aim is to determine the PPA/NPA against a comparator assay. The secondary aim is to determine the diagnostic sensitivity, specificity, PPV and NPV against the standard-of-care test. Each subjects will be asked to provide both nasal swab (NS) and nasopharyngeal swab (NPS) for testing purposes.
详细描述
The study is designed as a multisite, observational, prospective study. Subjects will be prospectively recruited from the target population, specifically individuals displaying signs and/or symptoms of respiratory tract infections. Consent for participation will be obtained prior to any eligibility confirmation or sample collection. Subsequently, both nasal swab (NS) and nasopharyngeal swab (NPS) specimens will be collected from each subject. These specimens will be tested using both the VitaSIRO solo™ SARS-CoV-2/Flu/RSV Assay and the Cepheid Xpert Xpress CoV-2/Flu/RSV plus assay (comparator) to determine the Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA).
Subjects will be recruited across up to 20 sites, targeting the following intended user groups:
Trained laboratory professionals in a central laboratory setting Trained healthcare practitioners in a point-of-care (POC) setting under CLIA moderate and high complexity.
If a standard-of-care (SOC) diagnosis is available, the sensitivity, specificity, Positive Predictive Value (PPV), and Negative Predictive Value (NPV) will also be calculated.
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
- •Subject displaying one or more of the following signs and/or symptoms of a respiratory tract infection:
- •Nasal Congestion
- •Shortness of breath
- •Difficulty in breathing
- •Sore throat
- •Muscle pain
- •New loss of taste/smell
- •If age 18 or over, subject is willing and capable of providing written informed consent. If under the age of 18, parent or legal guardian is willing to and capable of providing consent/assent. Assent should be obtained from minor subjects of appropriate intellectual age as defined by the IRB.
排除标准
- •Subject is unable to provide consent and assent (as appropriate) or parental/legal guardian consent permission and assent (as appropriate) cannot be obtained.
- •PI determines that specimen collection represents an unacceptable risk.
- •Subjects who have already been enrolled in the study previously.
研究组 & 干预措施
Symptomatic Cohort
Subjects displaying signs and/or symptoms of respiratory tract infections
干预措施: Credo POCT Device (Device)
结局指标
主要结局
Positive percent agreement(PPA) and Negative percent agreement (NPA)
时间窗: In 7 days after specimen collection
Positive percent agreement(PPA) and Negative percent agreement (NPA) between the VitaSIRO solo™ SARS-CoV-2/Flu/RSV and Cepheid Xpert® Xpress CoV-2/Flu/RSV plus assay
次要结局
- Comparison to SOC testing(In 7 Days after specimen collection)