Evaluation of the Feasibility and Reproducibility of 2 Point-of-Care Tests for SARS-Co-V-2 Antibodies (INSIGHT 017)

This study was designed to examine the feasibility of conducting point-of-care (POC) tests for SARS-CoV-2 antibodies and compare the reproducibility of these tests to tests run at a central laboratory on specimens obtained from the same study participants at the same time. In addition to this cross-sectional study (field test), a nested case-control study utilizing specimens already collected from participants in the Therapeutics for Inpatients with COVID-19 (TICO) trial was conducted.

The primary objective of the field test was to test for an association between the outcome of the locally obtained POC test and the centrally obtained result from the GenScript assay on a blood sample obtained at the same time as the sample for the POC tests.

The primary objective of the nested case-control study was to test for an association between the POC test result on stored baseline specimens and the primary efficacy outcome in TICO on a subset of specimens from TICO participants for whom the GenScript assay result has already been determined.

The planned study sample size was 375 participants.

For further details about the study, please go to ClinicalTrials.gov.