Healthy Volunteer COVID-19 Antibody Testing Study

Post Market Clinical Study of a Point of Care COVID-19 IgG-IgM Rapid Test in Healthy Volunteers

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.

Study Overview

• Status: Withdrawn
• Conditions: Covid19
• Intervention / Treatment: Diagnostic test: COVID-19 antibody point of care test kit

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.

• Study Type: Observational

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Healthy volunteers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Previously COVID-19 positive; Previously confirmed PCR positive for COVID-19 And/or positive COVID-19 antibody test in the past six months	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
Previously COVID19 negative; No previous symptoms of COVID-19	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity and specificity of the COVID-19 antibody testing kit	Immediate

Collaborators and Investigators

• Sponsor: Royal Free Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Daniel Martin, MB ChB, Royal Free Hospital NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2020
• Primary Completion (ANTICIPATED): January 29, 2021
• Study Completion (ANTICIPATED): April 30, 2021

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: August 26, 2020
• First Posted (ACTUAL): August 27, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Immunologic Factors; Antibodies
• Other Study ID Numbers: 134035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO