Respiratory Syncytial Virus Infections Clinical Trial
Official title:
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
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.
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).
The primary objective is to assess the feasibility of this novel single use product for the
diagnosis of influenza and other respiratory pathogens in upper airway samples at the POC in
acute clinical settings and compare the results against the conventional diagnostic methods
of PCR testing in the laboratory and or rapid flu testing (Cepheid, Sunnyvale, CA, USA).
While the secondary objective is to compare the results obtained in a clinical setting to the
analytical study data and laboratory test on stored samples. A further objective is to
develop a bank of research samples for further testing of the device in laboratory
conditions. Sensitivity, specificity, positive predictive value and negative predictive value
of the new POC device in fresh samples will be calculated and compared to the results on
stored samples.
The patient will be seen in the clinical setting on a one off visit. Any adult presenting
with Influenza Like Illness or a febrile illness associated with symptoms such as cough, sore
throat or rhinorrhoea, and for whom a respiratory viral screen is clinically indicated will
be recruited if they meet the eligibility criteria.
Consent will be taken by a qualified doctor, member of the local clinical care team, a
research nurse or clinical fellow.
Participants will also be provided with contact details of the study co-ordination centre for
future queries.
One nasal swab will be taken per patient recruited in addition to the swab(s) (nasal,
nasopharyngeal or throat swab) taken for standard care. The routine screening sample(s)
(Sample A) will be processed for standard PCR testing in the laboratory and/or rapid flu
testing (Cepheid, Sunnyvale, CA, USA) as per standard clinical screening. The test sample
(Sample B) will be taken for evaluation under the study and either: (i) transferred to the
new device buffer tube and promptly tested in a test device or (ii) if no device is available
for prompt testing, the swab will be transferred to a viral storage/transport buffer tube as
per standard procedures and frozen for long-term storage and testing at a later date.
The swab will be rotated up to 5 times and held in place for 5-10 seconds. The swab will then
be inserted into the single-use elution buffer tube containing the elution buffer and stirred
5 times. The swab will then be safely discarded in clinical waste. A volume of 200ul of
buffer will then be transferred to the sample chamber of the device using the fixed volume
pipette provided. The assay will be performed according to the 'Instructions for Use'
provided with the device. Results require no calibration, interpretation, or calculation. The
total time to result is expected to be approximately 10 minutes. The pathogens which will be
tested in the test device include one or more of the following: influenza A, influenza B,
respiratory syncytial virus, human rhinovirus/enterovirus, human metapneumovirus and
parainfluenza viruses.
All tests performed on the device will be performed 'blinded', i.e. the operator will be
unaware of the diagnostic standard of care result to ensure reading of results are not based
upon results obtained with standard tests. The test result will not be disclosed to either
the patient or the clinician. Each patient will be expected to participate for a total of 30
minutes.
As this is a feasibility study, diagnostic standard of care tests will be performed as per
the clinical pathway with routine sample(s) (A) and the results of the test devices will not
affect clinical decisions.
A minimum of 50 devices will be tested with fresh patient samples in a real life clinical
setting. Opportunistic patient samples will be collected and banked throughout the study
period. The aim will be to recruit as many patients as possible. A target of 200 patients has
been set based on 1600 viral PCRs taken at ICHNT last year over the influenza period and a
realistic estimate was made for the sample size for patients who may be willing to
participate in the study presenting with Influenza Like Illness, with consideration of time
and resource constraints. This data will be analysed to review the feasibility of this new
device.
Medical and demographic data will be collected during the study and documented on the
following case report forms (CRFs).
- Baseline CRF - Including demographic information, medical history, symptoms, signs and
observations at the time of recruitment
- Results CRF - Including results from the POC device, how many devices were required to
obtain a results, any issues with the device, results of the standard viral PCR results,
patient outcomes and use of anti-viral treatment.
Additional data will be collected where required using the following CRFs:
- Adverse Events/Serious Adverse Events CRF.
- Withdrawal CRF - to be completed if patient withdraws consent. This data will be
collected by a clinical research fellow or research nurses using participant hospital
records or from the participant directly. In addition, pseudo-anonymised test results
and imaging reports maybe collected. This could include but will not be limited to X-ray
reports, CT scan reports, and pathology reports.
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