ABSTRACT
The lateral flow immunoassay (LFIA) is a paper-based platform with extensive application in point-of-care (POC) testing and many fields. However, its clinical application is severely limited due to the lack of quantitative ability of standard LFIA tests; this augmentation provides the system with quantifying the signal from magenta-colored AuNPs. To address this issue, we proposed an ultra-compact optical system that allowed LFIAs to be performed more accurately and objectively. The experimental setup consisted of multiple optical accessories manufactured by 3D printing (STEP files were included). A high-resolution printer was used to print out a magenta card model for the LFIA, whose color code, ranging from 255, 255, 255 to 255, 0, 255 in the RGB (red, green, blue) format, represents different levels of magenta color intensity (from 0% to 100%) and thus the results of LFIA test strips. A mathematical model was built using a calibration curve to describe the relationship between magenta color value and reflectance spectrum. In addition, a spectrum module was integrated into the proposed system to identify and quantify LFIA results. This integration represents a pioneering step in developing portable detection techniques that facilitate quantifying LFIA results. Finally, we expect this ultra-compact optical spectroscopy system to have great potential for novel clinical applications.
ABSTRACT
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 AND 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.
