Magnetofluidic immuno-PCR for point-of-care COVID-19 serological testing
Pengfei Zhang1, Liben Chen2, Jiumei Hu2
1Department of Biomedical Engineering, Johns Hopkins University, Baltimore, MD, 21218, USA.
Insights
A new magnetofluidic immuno-PCR platform offers rapid and sensitive detection of COVID-19 antibodies. This point-of-care test provides accurate results in about 30 minutes, addressing limitations of current serological assays.
Area of Science:
- Biotechnology
- Immunology
- Medical Diagnostics
Background:
- Serological tests are crucial for COVID-19 management, including immune response monitoring and infection tracking.
- Conventional immunoassays offer sensitivity but lack speed and point-of-care suitability, while rapid tests compromise sensitivity.
Purpose of the Study:
- To develop a novel magnetofluidic immuno-PCR platform for rapid and sensitive point-of-care COVID-19 serological testing.
Main Methods:
- Development of a palm-sized magnetofluidic device automating magnetic bead-based immuno-PCR.
- Integration of a programmable magnetic arm, pre-loaded reagent cartridges, miniaturized thermocycler, and fluorescence detection.
- Assay performance evaluated using 108 clinical serum/plasma samples.
Main Results:
- The magnetofluidic immuno-PCR platform delivered results in approximately 30 minutes.
- Achieved a sensitivity of 93.8% (45/48) and specificity of 98.3% (59/60) in clinical sample testing.
Conclusions:
- The developed magnetofluidic immuno-PCR platform demonstrates significant potential as a rapid and sensitive point-of-care diagnostic tool for COVID-19 serology.
Abstract:
Serological tests play an important role in the fight against Coronavirus Disease 2019 (COVID-19), including monitoring the dynamic immune response after vaccination, identifying past infection and determining community infection rate. Conventional methods for serological testing, such as enzyme-linked immunosorbent assays and chemiluminescence immunoassays, provide reliable and sensitive antibody detection but require sophisticated laboratory infrastructure and/or lengthy assay time. Conversely, lateral flow immunoassays are suitable for rapid point-of-care tests but have limited sensitivity. Here, we describe the development of a rapid and sensitive magnetofluidic immuno-PCR platform that can address the current gap in point-of-care serological testing for COVID-19. Our magnetofluidic immuno-PCR platform automates a magnetic bead-based, single-binding, and one-wash immuno-PCR assay in a palm-sized magnetofluidic device and delivers results in ∼30 min. In the device, a programmable magnetic arm attracts and transports magnetically-captured antibodies through assay reagents pre-loaded in a companion plastic cartridge, and a miniaturized thermocycler and a fluorescence detector perform immuno-PCR to detect the antibodies. We evaluated our magnetofluidic immuno-PCR with 108 clinical serum/plasma samples and achieved 93.8% (45/48) sensitivity and 98.3% (59/60) specificity, demonstrating its potential as a rapid and sensitive point-of-care serological test for COVID-19.
