Journal of Clinical Trials
Open Access
ISSN: 2167-0870
+44 1478 350008
ISSN: 2167-0870
+44 1478 350008
Department of Pediatrics, University of California San Francisco, San Francisco, USA
Research Article
Clinical Evaluation of a COVID-19 Antibody Lateral Flow Assay using Point of Care Samples
Author(s): Won Lee, Steven Straube, Ryan Sincic, Jeanne A. Noble, Juan Carlos Montoy, Aaron E. Kornblith, Arun Prakash, Ralph Wang, Roland J. Bainton and Philip A. Kurien*
Introduction: The SARS-CoV-2 pandemic has spurred the development of numerous Point of Care (POC)
immunoassays. Previous studies assessing performance of these available kits occurred in a laboratory setting, raising
concerns of translating findings for POC use. We aim to assess the performance of a lateral flow immunoassay for the
detection of SARS-CoV-2 antibodies using samples collected at POC.
Method: One lateral flow immunoassay (Humasis® COVID-19 IgG/IgM) was tested. Fifty PCR RT-PCR positive and
52 RT-PCR negative samples were collected at POC. Fifty Pre-Covid serum specimens were used as controls. Clinical
data including symptom onset date was collected from patient history and the medical record.
Results: The overall sensitivity for the kit was 74% (95% CI: 59.7%-85.4%). The sensi.. View More»
DOI:
10.4172/2167-7964.1000324