The need for large-scale testing for COVID-19 has been highlighted by both the World Health Organization (WHO) and the UK government. Immunity to coronavirus 2019 (COVID-19) infection can be determined by detecting the presence of antibodies to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Immunoglobulins (Ig) to the SARS-CoV-2 develop during the second and third week of COVID-19 disease and can be detected by analyses conducted using laboratory tests. Accurate and scalable point-of-care testing (POCT) for the diagnosis of COVID-19 immunity would allow community diagnostic to be upscaled enormously. POCT for COVID-19 antibodies is possible using small disposable kits. POCT immunity testing using disposable kits will be imperative for effective surveillance and vaccinations programmes. The study aims to test a novel, rapid antibody testing kit (IgG and IgM) in order to confirm its accuracy in a healthy volunteer population. The antibody testing kit intended for use in the study has already been CE marked for this purpose.
This is a commercially funded prospective observational, cohort study of healthy volunteers
to assess the sensitivity and specificity of a point of care antibody assay for COVID-19 (the
ARIA COVID-19 IgG/IgM Rapid Test. The test is a disposable lateral flow chromatographic
cassette (CTK Biotech, Inc., USA). The kit is CE approved for its intended purpose.
200 healthy volunteers will be enrolled into one of two cohorts:100 who have been confirmed
to have had COVID-19 in the past (either by previous positive PCR swab or positive antibody
test) and 100 thought not to have been affected by COVID-19. Once they have provided written
informed consent to participate, volunteers will be invited to attend a 30 minutes
appointment for testing. Prior to testing they will be asked to complete a short
questionnaire to collect demographic information and details about previous symptoms of
COVID-19.
A finger prick blood sample will be taken from the patient and then tested in the ARIA
antibody kit. Afterwards, a routine blood sample (10 ml) will then be taken from the
participant. The blood sample will be used in three separate ways:
1. A small sample of blood will be immediately removed from the sample bottle and placed
into an ARIA antibody test kit.
2. One blood tube will be immediately centrifuged and a sample of plasma removed for use in
the ARIA antibody testing kit.
3. One tube will be sent to the designated laboratory for formal COVID-19 ELISA antibody
testing.
The ARIA antibody kit will be used to identify the presence of COVID-19 antibodies. The
results will be compared to a laboratory enzyme-linked immunosorbent assay (ELISA) for
COVID-19 antibodies. Once samples have arrived at the designated study laboratory they will
undergo a specified ELSIA test for COVID-19 antibodies conducted according to the laboratory
standard operating procedure for that test. For each sample type analysed (finger prick
blood, venous blood, and plasma) the sensitivity and specificity of the test will be
calculated against the results of the laboratory ELISA test.
Afterwards a brief exit questionnaire will be completed by the participant to document their
experience of the study.
Recruitment is expected to be completed within six months of commencing the study.
Diagnostic Test: COVID-19 antibody point of care test kit
A disponible point of care test that identifies the presence of antibodies to COVID-19
Inclusion Criteria:
- Adult (aged ≥ 18 years) healthy volunteers.
- For the positive group: PCR confirmed COVID-19 infection and/or positive antibodies
test in the past six months,
- For the negative group: Never had symptoms of COVID-19
- Able to attend hospital for a blood and finger-prick test
Exclusion Criteria:
- Current symptoms of COVID-19
- Positive COVID-19 test result in the last 14 days
- Receiving or have received immunosuppression (including systemic corticosteroids) in
the last 12 months
- Children (aged < 18years)
- Pregnancy
- Prisoners
Daniel Martin, MB ChB, Principal Investigator
Royal Free Hospital NHS Foundation Trust