Evaluation of near patient testing for influenza using Alere vs RTPCR
Research type
Research Study
Full title
Clinical evaluation of near patient testing for influenza A and B using the ALERE™ rapid nucleic amplification technique compared to standard laboratory based real time PCR.
IRAS ID
142754
Contact name
Mohammad Raza
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Research summary
Influenza or ’flu’ is a respiratory illness associated with infection by influenza virus. There is a wide spectrum of severity of illness ranging from minor symptoms through to pneumonia and death. There are 2 common types of influenza virus – A and B. Influenza A tends to cause more severe disease, and is usually implicated in pandemics.
Often, influenza is diagnosed clinically, upon recognition of the pattern of symptoms. However, influenza may also present in unusual ways, for example: bronchitis, secondary bacterial pneumonia, gastroenteritis or, in children, ear infections, which can make it more difficult to diagnose.
Apart from influenza, a number of other infections can cause a similar illness. Although there are some important features which differentiate influenza from the rest, due to significant overlap in symptoms and signs, diagnostic laboratory tests are important to confirm the diagnosis.
Alere™ diagnostics have developed a rapid near patient test (NPT) for influenza which can give a result in 15 mins. Currently, we use a real time polymerase chain reaction (RTPCR) test in the Sheffield Teaching Hospitals NHS Foundation Trust laboratories which takes 5-7 hours. However, further delays can occur due to transport delay to the laboratory and the time of day the sample arrives in the laboratory. The average time for a valid result from the time the sample was taken last winter was 24-72 hours. We would therefore like to evaluate if the Alere™ near patient test is as accurate as our standard laboratory test and could be used in the future to provide rapid results for patients who may have influenza.It is important to identify influenza accurately for three reasons: 1) Anti-viral treatment is available for influenza, but is most effective if started within 24 hours of symptom onset; 2) Influenza is a highly infectious virus and can cause outbreaks amongst vulnerable patients within the hospital setting; 3) Influenza can cause more severe disease and significant mortality. Confirmation of the cause of the illness allows medical teams to predict the natural history of the presenting illness, to use anti-viral drugs safely, to ensure appropriate infection control measures are in place and may allow more rapid discharge of patients.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
13/YH/0404
Date of REC Opinion
10 Dec 2013
REC opinion
Favourable Opinion