Development of a rapid diagnostic test for the detection of antibodies or antigens to Coronavirus (COVID-19)

Abstract

Theglobal health crisis caused by COVID-19 has overwhelmed both healthcaresettings and economies globally. Whilst mass population testing has improveddrastically, recent reviews of existing methods have highlighted variousshortcomings with these methods. Theaim of this project was to investigate whether the LAA could be modified andutilised as rapid detection test which either matched or exceeded the existingsensitivity and specificity values.   TheLAA investigated whether the COVID-19 spike protein could be detected insamples. COVID-19 specific IgM and IgG were used in conjunction with a seriesof non-specific antigens. Control or AG containing samples weremixed with AB-microsphere complexes on glass microscope slides. Manualvisualisation identified various levels of agglutination. Light microscopy andspectrophotometry at 405nm determined that the LAA could detect at least 2.3ngof spike protein.  Theparticle counting tool of ImageJ was utilised to obtain a dataset which wassubjected to statistical analysis which indicated that there was a significantdifference between control samples and live tests, P = 0.000102 for the spikeprotein assay and P = 0.254 for the non-specific assay respectively. Theresults obtained fell in line with a similar study conducted by Buffin et al in2018. Theanalytical methods used in this project twinned with data obtained in previousstudies supports the significant difference between control values and livetest values. The LAA is easier, quicker to use (results in ≤ 30 minutes) andcheaper, with potentially better sensitivity to existing methods. This couldbenefit high and low-income countries alike upon further research andoptimisation.