Evaluation of a COVID-19 antibody test: What is the performance of the Panbio™ COVID-19 IgG/IgM rapid test device in fingerstick blood, venous whole blood, serum and plasma in adult participants?

Panbio™ COVID-19 IgG/IgM rapid test device matrix equivalence study: evaluating test performance in comparison with a laboratory reference method using venous whole blood, serum and plasma as well as capillary whole blood from adult participants

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN60400862

Enrollment

206

Registered

2020-06-22

Start date

2020-05-15

Completion date

Unknown

Last updated

2022-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19 (SARS-CoV-2 infection) past exposure Infections and Infestations

Interventions

All participants provided a fingerstick capillary whole blood sample as well as a venous blood sample. All participants had a fingerstick capillary whole blood sample, a venous EDTA whole blood sample

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Aged 18 years or older 2. Known to have been infected with SARS-CoV-2, or who have not been infected with SARS-CoV-2 3. Agrees to complete all aspects of the study

Exclusion criteria

Exclusion criteria: 1. Belongs to a study group that has been filled 2. Has already participated in this study on a previous occasion 3. Is enrolled in a study to evaluate a new drug 4. Unable or unwilling to provide informed consent 5. Is a vulnerable person as deemed unfit for the study by the Principal Investigator

Design outcomes

Primary

Measure	Time frame
User’s test result interpretation of the Panbio™ COVID-19 IgG/IgM rapid test device at 10 minutes and at 20 minutes after sample application, using fingerstick whole blood, venous whole blood and venous serum, in comparison with venous plasma	—

Secondary

Measure	Time frame
1. User’s test result interpretation of the Panbio™ COVID-19 IgG/IgM rapid test device at 10 minutes and at 20 minutes after sample application using fingerstick whole blood, venous whole blood, venous serum and venous plasma, in comparison with laboratory reference tests 2. Prevalence of COVID-19 antibodies in all participants at the time of enrolment, as determined by a laboratory-based test	—

Measure

Time frame

1. User’s test result interpretation of the Panbio™ COVID-19 IgG/IgM rapid test device at 10 minutes and at 20 minutes after sample application using fingerstick whole blood, venous whole blood, venous serum and venous plasma, in comparison with laboratory reference tests 2. Prevalence of COVID-19 antibodies in all participants at the time of enrolment, as determined by a laboratory-based test

—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026