Evaluating home antibody test kits for the detection of coronavirus (COVID-19) antibodies
- Conditions
- COVID-19 (SARS-CoV-2 infection)Infections and Infestations
- Registration Number
- ISRCTN56609224
- Lead Sponsor
- Public Health England
- Brief Summary
2021 Preprint results in https://doi.org/10.1101/2021.01.30.21250777 comparing AbC-19™ Rapid Test, OrientGene COVID IgG/IgM Rapid Test Cassette, SureScreen COVID-19 Rapid Test Cassette, and Biomerica COVID-19 IgG/IgM Rapid Test (added 13/08/2021) 2020 Results article in https://pubmed.ncbi.nlm.nih.gov/33177070/ AbC-19 Rapid Test (added 13/08/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36135374/ (added 29/09/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 4842
1. Currently working on-site at their place of work
2. Aged =18 years
3. Able to read English
4. Has an in-use personal email address and mobile phone
1. Is currently experiencing COVID-19 compatible symptoms
2. Has experienced COVID-19 compatible symptoms in the last seven days
3. Meets the definition of exceptionally vulnerable” on medical grounds, including immunosuppression, previous oncological treatments – these people should not be at work anyway
4. Unable to read normal-sized print with glasses
5. Taking part in vaccine studies
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Sensitivity, specificity, positive and negative predictive values of home testing kits (HTKs) for previous SARS-CoV-2 infection measured through patient-reported results when using HTKs observed by research staff compared to results from a gold standard” reference test (laboratory immunoassay) of venous samples between baseline and 1 year
- Secondary Outcome Measures
Name Time Method