Prospective In Vitro Diagnostic Clinical Performance Study for an Influenza A+B Point-of-Care Test Kit on Patients Exhibiting Influenza-like Illness
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- The clinical sensitivity and clinical specificity of the investigational devices
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Have had influenza-specific treatment.
Outcomes
Primary Outcomes
The clinical sensitivity and clinical specificity of the investigational devices
Time Frame: 2 Years
Establish clinical sensitivity and specificity of investigational devices by comparing with PCR results using fresh and frozen sample
Secondary Outcomes
No secondary outcomes reported