Evaluation of a Single Use Point of Care Device for the Diagnosis of Influenza and Other Respiratory Pathogens in Clinical Upper Airway Samples Using Isothermal Amplification - a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Assessing the Feasibility of a Single Use Diagnostic Point of Care Test Against Standard Care Testing Methods, in a Real-life Clinical Setting.
研究概览
简要总结
This study evaluates a single use point of care diagnostic test in the diagnosis of influenza and other respiratory viral infections in adults. Participants will have a sample taken from their nose using a swab. The swab will be gently mixed in a liquid solution which will then be transferred into the device for testing.
详细描述
Influenza, commonly known as "the flu", is an infectious disease caused by influenza viruses.
Influenza can contribute towards the development of pneumonia, sinus infections and worsening of previous health problems such as asthma or heart failure. Healthy people can get very sick from the flu and other respiratory viral infections and spread them to others. Therefore, early detection is essential for the effective management of these infections. Infection prevention and control measures including patient isolation, commencing anti-viral treatment and whether or not hospital admission is required can all be positively influenced by the rapid diagnosis of infection.
Current influenza testing can be performed by numerous methods. The gold standard is via molecular assays including rapid molecular assays and reverse transcription polymerase chain reaction (RT-PCR). Serological testing and antigen detection tests including immunofluorescence assays are other methods but the sensitivity and specificity for these tests are variable and tend to be lower than molecular testing methods.
In the United Kingdom (UK), influenza testing relies on clinical suspicion and the use of respiratory viral PCR in the laboratory. The turn-around-time for this can still take upto 48 hours. Point of care (POC) testing has been considered by Public Health England, as platforms with the potential to be used within 20 metres of patients and the results to be available within 10 to 90 minutes. This new device is a true point of care test which can be performed by the bedside with the results available within 10-15 mins.
This is a prospective single centre feasibility study carried out in an acute clinical setting, the Accident and Emergency (A+E) department of Imperial College Healthcare National Health Service (NHS) Trust (ICHNT).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Any adult ≥18 years of age presenting to the A+E department with ILI or a febrile illness associated with symptoms such as cough, sore throat or rhinorrhoea, and for whom a respiratory viral screen is clinically indicated and who is:
- •Able to provide written informed consent, or written informed assent by a relative or carer
- •Recruited during initial medical assessment
- •Able to comply with the study protocol
排除标准
- •Previously recruited within 28 days of the current admission
- •Enrolment in a trial of antimicrobial therapy
- •If patients are unable to understand verbal or written information in English, hospital translation services will be sought but not guaranteed. However, if the team member seeking consent is not satisfied that the potential recruits' English language ability is sufficient to completely understand the study protocol and requirements (despite use of hospital translation services) then they will not be recruited to the study.
结局指标
主要结局
Assessing the Feasibility of a Single Use Diagnostic Point of Care Test Against Standard Care Testing Methods, in a Real-life Clinical Setting.
时间窗: through study completion, an average of 1.5 years
The primary outcome will be to review the feasibility and the diagnostic accuracy for viral respiratory pathogens in this novel device using fresh patients' samples in a real-life clinical setting compared to the standard diagnostic testing of a respiratory viral PCR in the laboratory and/or rapid flu swab (Cepheid, Sunnyvale, CA, USA) using sensitivity, specificity, positive predictive value and negative predictive values. A minimum of 50 devices will be tested with fresh patient samples in a real life clinical setting.
次要结局
- To Compare the Results Obtained in a Clinical Setting to the Analytical Study Data and Laboratory Tests on Stored Samples.(through study completion, an average of 1.5 years)