COVID-19 (SARS-CoV-2 infection) past exposure Infections and Infestations
Conditions
Interventions
All participants provided a fingerstick capillary whole blood sample for testing with the Panbio™ professional use test by a study staff member. All participants also provided a venous EDTA whole bloo
Sponsors
Abbott Rapid Diagnostics (Germany)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participant is 16 years of age (UK) / 18 years of age (Spain) or older. 2. Only Self-testers and those being tested by another lay user: Individuals with a prior suspected or confirmed COVID-19 infection with prior COVID-19 symptoms with symptom onset > 21 days prior to the study (n=at least 200) or symptom onset 14-21 days prior to the study (n=up to 30) or with a past asymptomatic infection (n= up to 30) or individuals having received COVID-19 vaccine, 30 days or more after they have received their second dose of the BNT162b2 (Pfizer) or of the mRNA-1273 (Moderna) vaccine, or a single dose of the Janssen COVID-19 Vaccine (Johnson & Johnson). (n=at least 30). These participants could be invited to the study based on a positive SARS-CoV-2 PCR result or vaccination in their medical records, and be confirmed to be study reference positive using study reference testing. The asymptomatic participants could be enrolled also through the presumed reference-negative cohort. or 3. Evaluable individuals not suspected to have had a COVID-19 infection (n=at least 200) 4. Participant agrees to complete all aspects of the study. 5. In addition, "care-giver” testing will also be included in the self-test validation, where one lay user tests another lay user. This is intended to simulate testing in a care-giver situation; the study does not require one lay user to be the real-life care-giver for the other. No vulnerable population will be included in this study. Furthermore, lay user individuals will be enrolled to interpret the self-tester results. These individuals will be classified as “readers.” One reader may interpret up to three test results. A participant may be enrolled both as a self-tester or a “care-giver” or a person being tested and as a reader of another person’s test result. This will allow the self-test result interpretation to remain blinded.
Exclusion criteria
Exclusion criteria: 1. Participant has already participated in this study on a previous occasion. 2. Only self-testers or those being tested by another lay user: Participant is enrolled in a study to evaluate a new drug. 3. Participant has a visual impairment that cannot be restored using glasses or contact lenses. 4. Participant is unable or unwilling to provide informed consent. 5. Participant is a vulnerable person as deemed unfit for the study by the Principal Investigator. 6. Participant has a condition deemed unfit by the investigator to safely perform or receive the test. 7. Participant is a practicing healthcare professional or laboratory scientist/technician (self-testers, “care-givers” and readers).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The diagnostic sensitivity and specificity of the Panbio™ COVID-19 Antibody Self-Test using fingerstick capillary whole blood, when the test is performed by lay users, in comparison with the SARS-CoV-2 IgG II Quant assay, performed on the Abbott Architect® platform. 2. Diagnostic sensitivity and specificity of the Panbio™ COVID-19 IgG Rapid Test using fingerstick capillary whole blood and venous plasma, when the test is performed by professional users, in comparison with the SARS-CoV-2 IgG II Quant assay, performed on the Abbott Architect® platform. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluated qualitative data from lay users on the test usability. Mock devices will also be used for the lay user usability and result interpretation evaluation at a single time point. 2. Matrix equivalence (% positive, negative and overall agreement) of fingerstick capillary whole blood compared to venous plasma for use with the Panbio™ COVID-19 IgG Rapid Test, when the Panbio™ test is performed by a professional user. 3. Diagnostic sensitivity, specificity, and overall agreement of the Panbio™ COVID-19 Antibody Self-Test as performed by lay users using fingerstick samples, in comparison with the Panbio™ COVID-19 IgG Rapid Test as performed by professional non-laboratory staff, also using fingerstick samples. | — |
Countries
England, Spain, United Kingdom
Outcome results
None listed