Prospective In Vitro Diagnostic Clinical Performance Study for an Influenza A+B Point-of-Care Test Kit on Patients Exhibiting Influenza-like Illness
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- The clinical sensitivity and clinical specificity of the investigational devices
研究概览
简要总结
Prospective clinical study on the performance of an Influenza A+B rapid test kit. The main goal is to establish the sensitivity and specificity (i.e. how accurate the test is) when compared to a gold standard.
Option of participating in this clinical study will be presented to patients displaying influenza-like illness. Informed consent will be collected from patients or patient's next of kin/guardian before samples (nasopharyngeal swab) are taken from the patient.
Nasopharyngeal swabs are tested using both the investigational test kit and a predicate fluorescence immunoassay test kit. All samples will be tested using a molecular-based PCR test kit as a confirmatory test.
The results will be analysed statistically and the performance of the Influenza A+B test kit can be evaluated.
详细描述
Influenza is an acute respiratory infection caused by influenza viruses which circulate in all parts of the world. Influenza viruses are causative agents of highly contagious, acute, viral infections of the respiratory tract. Influenza viruses are immunologically diverse, single-stranded RNA viruses.
There are 3 types of seasonal influenza viruses, types A, B, and C. Influenza A+B and B viruses circulate and cause outbreaks and epidemics. Influenza type C virus is detected much less frequently and usually causes mild infections, thus presents less significant public health implications.
Seasonal influenza has an incubation period of approximately 2 days and is characterized by a sudden onset of fever, cough, headache, muscle and joint pain, severe malaise, sore throat and a runny nose. Most people recover within a week without requiring medical attention but influenza can cause severe illness or death especially in vulnerable populations such as children, pregnant women and elderlies. Seasonal influenza causes public health concerns as it spreads easily, with rapid transmission in crowded areas including schools and nursing homes.
Antiviral drugs for Influenza A and Influenza B are available in some countries and may reduce severe complications and deaths. Ideally these antiviral drugs need to be administered within 48 hours of onset of symptoms and hence rapid diagnosis of influenza in patients displaying influenza-like Illness can reduce the number of severe complications and deaths associated with influenza.
Fluorescent Immunoassay is a biochemical technique used for detecting the binding of the "detection" antibody and the analyte molecule. The advantages of a fluorescent detection system have been known for many years. These include higher sensitivity detection of the analyte, simplified reagents and simpler assay designs. Several breakthroughs have occurred over the past few years that have enabled the implementation of a fluorescent based immunoassay system at the point of care.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is having NPA collected by the hospital as routine testing
- •Patient or patient's next of kin/guardian is willing and able to give informed consent for participation in the trial.
- •Patients presented with influenza-like illness, i.e. fever and cough, with onset of illness within 7 days of hospital admission
- •Male or Female, 18 years of age or above.
排除标准
- •Have had influenza-specific treatment.
结局指标
主要结局
The clinical sensitivity and clinical specificity of the investigational devices
时间窗: 2 Years
Establish clinical sensitivity and specificity of investigational devices by comparing with PCR results using fresh and frozen sample
次要结局
未报告次要终点