Orient Gene 5in1: SARS-CoV-2, influenza A&B, RSV and ADV Antigen Test
Research type
Research Study
Full title
Performance and Usability Evaluation of OrientGene 5 in 1 SARS-CoV-2, influenza A, influenza B, Respiratory Syncytial Virus (RSV) and Adenovirus (ADV) Antigen Self-Test (product code: GCFCRA-T525a) Performance and Usability Evaluation
IRAS ID
325511
Contact name
Tara Moore
Contact email
Sponsor organisation
Accubio
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary:
According to the World Health Organisation (WHO), lower respiratory tract infections are the third greatest cause of mortality worldwide, accounting for 6.1% of total deaths.The Orient Gene 5 in 1 SARS-CoV-2, influenza A, influenza B, Respiratory Syncytial Virus (RSV) and Adenovirus (ADV) Antigen Self-Test is a qualitative assay (lateral flow test) for the detection of SARS-CoV-2, influenza A, influenza B, Respiratory Syncytial Virus (RSV) and Adenovirus (ADV) antigens in nasal swab specimens from symptomatic individuals within the first seven days of symptom onset. This is key in the current climate as it allows the differentiation of patients with COVID-19 from other infections.
This study will recruit participants from Belfast and Liverpool who display symptoms of acute respiratory infection (ARI) (a cough or at least two new or worsening ARI symptoms ie, feeling feverish, headache, chills or shivering, sore throat, nausea or vomiting, runny or stuffy nose, malaise, muscle or body aches, trouble breathing, diarrhoea, rash, ear pain, or discharge in the previous 72 hours). Study participants will be recruited via a number of sources, including, but not limited to, social media, email, flyers, local GP clinics, work place, students and Covid clinics. The study is designed to test the ability of non-trained operators to read and understand the instructions for use such that they can collect a sample, perform the test and interpret the results. Therefore, training in the use of the Orient Gene 5 in 1 COVID-19, influenza A, influenza B, Respiratory Syncytial Virus (RSV) and Adenovirus (ADV) Antigen Self-Test will not be carried out, however, each study participant will be given an Instructions For Use (IFU) Results will be compared to a currently available RT-PCR (Reverse transcription-polymerase chain reaction) test results, taken by the study participant at the same time.
Study participants will be recruited as follows according to three age ranges:
• Adults over the age of 18 years old can do a self-test.
• Adolescents 12-17 years old can do a test under the supervision of an adult.
• Children under 12 years old should be tested by an adult.Target recruitment is anticipated to be approximately 3,000 to ensure that sufficient positives for each virus are obtained as follows [1] Flu A n= 26, [2] Flu B n= 35, [3] RSV n =18, [4] Adeno n= 18, [5] Covid n= 100.
Study participants (or, in the case of a child, a parent / guardian) will be asked to perform the lateral flow test. Each study participant will be asked to conduct a video recording whilst undertaking the lateral flow test, this will be available to review, if required, during the analysis of the data to determine whether the lateral flow has been conducted correctly. Any deviations from the correct procedure will be recorded in a Case Report Form (CRF). The video will only record the procedure, and will not record the study participant’s face. The study participant can decline to participate in this part of the study.
A subset of at least 100 (70 negatives, 30 positives) participants will be closely observed in a user experience (UX) study whilst carrying out the sample collection and testing. During this subset study any use difficulties or use errors will be documented by the investigator. The study will assess the usability / user experience of the test by asking each participant in this subset to complete a usability questionnaire. This information will be analysed and an assessment made whether any further action such as an update to the product labelling or IFU are required.
No study procedures will occur without full written informed consent / assent.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0079
Date of REC Opinion
1 Jun 2023
REC opinion
Further Information Favourable Opinion