COVID-19 SARS-CoV-2 Antibody Testing Study

• Conditions: Healthy

• Registration Number: NCT05009888
• Lead Sponsor: King's College London

Brief Summary

SATS is a single site feasibility study to assess the practical and psychological feasibility of using rapid COVID antibody testing of blood obtained from fingertip pin-pricks.

Detailed Description

SATS is a feasibility study conducted at a single site - King's College London and South London and Maudsley staff working at the Institute of Psychiatry, Psychology and Neuroscience (IoPPN) at Denmark Hill, London, England. The practical and psychological feasibility of using rapid COVID antibody testing of blood obtained from fingertip pin-pricks will be assessed.

Study Timeline

• Status Verified: 2021-08
• Study Start: 2021-08
• Study First Submitted: 2021-08-12
• Study First Submitted QC: 2021-08-17
• Last Update Submitted: 2021-08-17
• Study First Posted: 2021-08-18
• Last Update Posted: 2021-08-18
• Primary Completion: 2022-08
• Study Completion: 2022-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• King's College Staff member
• Aged 18 years or over
• Able to freely give informed consent

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

• known to have an infectious disease including a current SARS-CoV-2 infection.

• Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the research study, or may influence the result of the research study, or the participant's ability to participate in the research study. Examples of disorders or diseases which would be excluded include:

  • Medically diagnosed bleeding disorder;
  • Medically diagnosed platelet disorder;
  • Anticoagulant medication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Test validity of the antibody tests that are performed	1 Year	the number of completed tests that are valid with a positive/negative IgG/IgM result and confirmed with a positive control line compared with invalid test results as confirmed with a negative control result.
Acceptability of performing antibody testing procedures involving a capillary blood sample collected via finger-prick	1 Year	o Acceptability would be represented by the number of participants who consent to and complete the antibody testing procedure.

Secondary Outcome Measures

Name	Time	Method
o Representativeness of participants psychological and behavioural reaction to the testing procedure, their test results, and their willingness to be re-tested.	1 Year	Assessed by psychometric testing using visual analogue scales
o Representativeness of participants sampled	1 Year	This would be assessed using demographic data collected from participant