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BinaxNOW™ COVID-19 IgG Rapid / BinaxNOW™ COVID-19 Antibody Self Test Study

Abbott Rapid Diagnostics Jena GmbH is recruiting patients for the clinical trial of BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test.

Performance evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device (Professional Use) and with BinaxNOW™ COVID-19 Antibody Self Test wehn used with fingerstick capillary whole blood and plasma samples. The BinaxNOW™ Antibody Tests are lateral flow tests that measure SARS-CoV-2 IgG antibodies.

Operator of the device will be blinded to the outcome.

The researchers plan that June 3, 2021 will be the study start date. The indicative completion of the clinical trial will be expected in August 31, 2021.

Among primary outcome measures are the Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test and to evaluate the clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test when used by a lay person.

The page dedicated to this clinical trial can be found here: https://ichgcp.net/clinical-trials-registry/NCT04959760.

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