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.

Background The COVID-19 pandemic has spread globally in a short period of time. It is known that antibody (nAb) level can effectively predict vaccine efficacy, which leads to the exploration of vaccine trials for efficacy assessment. Thus, the current study aimed to develop a platform to quantify nAb levels faster, at lower cost, and with better efficiency. Material/Methods A total of 69 sera samples were collected for the research, 28 of which were from unvaccinated participants. The other 27 samples and the remaining 14 samples were from the participants who had received the first and second dose, respectively, of AZ vaccine 1 month before. With cPass assays (Genscript cPass nAb ELISA assay) used as a criterion standard and lateral flow immunoassay kit (Healgen Scientific – LFIA test kit) coupled with a spectrometer (LFIA+S) for checking each specimen, we aimed to detect the presence of neutralizing antibodies in sera and to confirm the relationship between the inhibition rate from cPass assays and the nAb index from the LFIA+S. Results Data analysis of the research were taken from the certified ELISA and LFIA+S, which indicated a high consistency (Pearson’s r=0.864; ICC=0.90138) between the 2 methods. Conclusions The dataset demonstrated that LFIA+S was affordable, had a strong correlation with results of the cPass nAbs detection kit, and has potential clinical applications, with an exclusive feature that allows non-experts to use it with ease. It is believed that the proposed platform can be promoted in the near future.

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