జర్నల్ ఆఫ్ క్లినికల్ ట్రయల్స్
అందరికి ప్రవేశం

నైరూప్య

Clinical Evaluation of a COVID-19 Antibody Lateral Flow Assay using Point of Care Samples

Won Lee, Steven Straube, Ryan Sincic, Jeanne A. Noble, Juan Carlos Montoy, Aaron E. Kornblith, Arun Prakash, Ralph Wang, Roland J. Bainton, 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 sensitivity for IgM and IgG detection >14 days after date of onset was 88% (95% CI: 68.8%-97.5%) and 84% (95% CI: 63.9%-95.5%), with a Negative Predictive Value (NPV) of 94% for IgM (95% CI: 83.5%-98.8%) and 93% for IgG (95% CI: 81.8%-97.9%). The overall specificity was 94% (95% CI: 83.5%-98.8%). The Immunoglobulin specific specificity was 94% for IgM (95% CI: 83.5%-98.8%) and 98% for IgG (95% CI: 89.4%-100.0%).

Discussion and Conclusion: Humasis^® COVID-19 IgG/IgM LFA demonstrates greater than 90% NPV for samples collected 14 days after the onset of symptoms using samples collected at POC.