Rapid Antigen and Antibody Microfluidic Immunofluorescence Assays Compared to Culture, PCR, and Laboratory Reference Tests: Performance in a Longitudinal Cohort

Author:

Dalmat Ronit R12ORCID,Hao Linhui34,Prabhu Roshni1,Rechkina Elena1,Hamilton Daphne1,Ikuma Matthew H1,Bauer Marie1,Gale Michael45,Cantera Jason L6,Ball Alexey S6,Grant Benjamin D6,Drain Paul K123ORCID

Affiliation:

1. International Clinical Research Center, Department of Global Health, Schools of Medicine and Public Health, University of Washington , Seattle, Washington , USA

2. Department of Epidemiology, School of Public Health, University of Washington , Seattle, Washington , USA

3. Division of Allergy and Infectious Diseases, Department of Medicine, School of Medicine, University of Washington , Seattle, Washington , USA

4. Department of Immunology, Center for Innate Immunity and Immune Disease, University of Washington , Seattle, Washington , USA

5. Center for Emerging and Re-emerging Infectious Diseases, University of Washington , Seattle, Washington , USA

6. Global Health Labs , Bellevue, Washington , USA

Abstract

Abstract We evaluated the performance of rapid antigen (RAg) and antibody (RAb) microfluidic diagnostics with serial sampling of 71 participants at 6 visits over 2 months following severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Rapid tests showed strong agreement with laboratory references (κAg = 81.0%; κAb = 87.8%). RAg showed substantial concordance to both virus growth in culture and PCR positivity 0–5 days since symptom onset (κAg-culture = 60.1% and κAg-PCR = 87.1%). PCR concordance to virus growth in culture was similar (κPCR-culture = 70.0%), although agreement between RAg and culture was better overall (κAg-culture = 45.5% vs κPCR-culture = 10.0%). Rapid antigen and antibody testing by microfluidic immunofluorescence platform are highly accurate for characterization of acute infection.

Funder

Bill and Melinda Gates Foundation

National Institutes of Health

Publisher

Oxford University Press (OUP)

Subject

Infectious Diseases,Immunology and Allergy

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3. Diagnostics for COVID-19: moving from pandemic response to control;Peeling;Lancet,2022

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