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. 2023 Oct 18;228(8):1066-1070.
doi: 10.1093/infdis/jiad231.

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

Ronit R Dalmat  1   2 , Linhui Hao  3   4 , Roshni Prabhu  1 , Elena Rechkina  1 , Daphne Hamilton  1 , Matthew H Ikuma  1 , Marie Bauer  1 , Michael Gale Jr  4   5 , Jason L Cantera  6 , Alexey S Ball  6 , Benjamin D Grant  6 , Paul K Drain  1   2   3
Affiliations

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

Ronit R Dalmat et al. J Infect Dis. .

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.

Keywords: COVID-19; SARS-CoV-2; antigen test; infectivity; longitudinal; rapid diagnostic test; serial testing.

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Conflict of interest statement

Potential conflicts of interest. P. K. D. reports having received research grants from the US National Institutes of Health, the US Centers for Disease Control and Prevention, the US Department of Defense, the Bill and Melinda Gates Foundation, and Abbott Diagnostics, all outside of the submitted work. All other authors report no potential conflicts. All authors have submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Conflicts that the editors consider relevant to the content of the manuscript have been disclosed.

Figures

Figure 1.
Figure 1.
Results of coincident test types over time since symptom onset. A, Positivity of tests (PCR, RDT Ag, viral growth in culture, RDT Ab) over time since symptom onset. B, Individual patterns of RDT Ag and RDT Ab test results, and symptoms over time since symptom onset. Abbreviations: Ab, antibody; Ag, antigen; PCR, polymerase chain reaction; RDT, rapid diagnostic tests.
See this image and copyright information in PMC

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