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

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.