The early detection of immunoglobulins via optical-based lateral flow immunoassay platform in COVID-19 pandemic

PLoS One. 2021 Jul 20;16(7):e0254486. doi: 10.1371/journal.pone.0254486. eCollection 2021.

Abstract

The coronavirus disease (COVID-19) is the global public health challenge currently persisting at a grand scale. A method that meets the rapid quantitative detection of antibodies to assess the body's immune response from natural COVID-19 illness or vaccines' effects is urgently needed. In the present study, an attempt was made to integrate a newly designed spectrometer to the COVID-19 test strip procedure; this augmentation provides the quantitative capacity to a lateral flow immunoassay (LFIA). Optical interpretation of results by quantitative α index, rather than visual qualification, can be done quickly, in 5-10 minutes. The developed product was compared with several other serological IgM/IgG antibody reagents on the market by recruiting 111 participants suspected of having COVID-19 infection from March to May 2020 in a hospital. Taking RT-PCR as the diagnostic gold standard, the quantitative spectral LIFA platform could correctly detect all 12 COVID-19 patients. Concerning RT-PCR negative patients, all three antibody testing methods found positive cases. The optical-based platform exhibited the ability of early detection of immunoglobulins of RT-PCR negative patients. There was an apparent trend that elevation of IgM levels in the acute phase of infection; then IgG levels rose later. It exhibited the risk of a false-negative diagnosis of RT-PCR in COVID-19 testing. The significant detection ability of this new optical-based platform demonstrated clinical potential.

Publication types

  • Research Support, Non-U.S. Gov't

Grant support

This research was funded by SpectroChip Inc., Taipei Hospital Ministry of Health and Welfare, and the Ministry of Science and Technology in Taiwan (MOST 109-2628-B- 192-001 and MOST 110-2218-E-011-008). The staff of SpectroChip Inc. mainly provides some experimental technical support in this research. In addition, SpectroChip Inc. provides some rapid screening reagents of Covid-19 for experimental use. SpectroChip Inc. has no other direct or indirect financial sponsorship in the study.