Self- and Parent/Guardian-Collection of Specimens for Rapid Influenza Nasal Swab Home Collection Kit (NSHC Kit) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,181
- 试验地点
- 2
- 主要终点
- Diagnostic specificity of self-collected to technician collected nasal swab samples
研究概览
简要总结
The purpose of this study is to demonstrate that persons over the age of 13 years can obtain a self-collected nasal swab reliably and safely for subsequent use in the diagnosis of influenza. Similarly, the purpose is to demonstrate that parents or guardians can safely and effectively collect nasal swab specimens from children, ages 0 through 12 years, and others needing assistance in doing so, and that these parent/guardian-collected nasal swabs can also be used in the diagnosis of influenza. Clinical performance of the swabs will be based on the comparison of the performance of the nasal swab that is self- or parent/guardian-collected to one collected from the same specimen donor by a skilled clinical coordinator and used in CLIA (Clinical Laboratory Improvement Amendments)-waived, rapid diagnostic test called Sofia Influenza A+B FIA (fluorescence immunoassay analyzer).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Nasal Congestion
- •Rhinorrhea
- •Sore Throat
排除标准
- •Unable to read and understand or refusal to sign the appropriate informed consent/assent forms
- •Refusal to complete the patient's demographic and medical history
- •Treatment with anti-influenza antivirals within the previous 7 days
- •Vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
结局指标
主要结局
Diagnostic specificity of self-collected to technician collected nasal swab samples
时间窗: 1 day (Participant); 17 weeks (Study length)
Hypothesis tested is that self-collected nasal swab are as accurate as nasal swabs collected by a trained healthcare worker for the diagnosis of influenza by CLIA-waived, rapid diagnostic test called Quidel Sofia Influenza A+B Fluorescent Immunoassay. The investigators will specifically measure the specificity of self-collected specimens as compared to the clinical standard (trained healthcare worker collected specimen), estimating it using standard methods along with 95th% confidence intervals.
Diagnostic sensitivity of self-collected to technician collected nasal swab samples
时间窗: 1 day (Participant); 17 weeks (Study length)
Hypothesis tested is that self-collected nasal swab are as accurate as nasal swabs collected by a trained healthcare worker for the diagnosis of influenza by CLIA-waived, rapid diagnostic test called Quidel Sofia Influenza A+B Fluorescent Immunoassay. The investigators will specifically measure the sensitivity of self-collected specimens as compared to the clinical standard (trained healthcare worker collected specimen), estimating it using standard methods along with 95th% confidence intervals.
次要结局
未报告次要终点