Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-27 @ 11:26 PM
Study NCT ID:
NCT04529460
Status:
WITHDRAWN
Last Update Posted:
2021-10-14
First Post:
2020-08-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healthy Volunteer COVID-19 Antibody Testing Study
Sponsor:
Royal Free Hospital NHS Foundation Trust
Organization:
Study Overview
Official Title:
Post Market Clinical Study of a Point of Care COVID-19 IgG-IgM Rapid Test in Healthy Volunteers
Status:
WITHDRAWN
Status Verified Date:
2021-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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.
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: