Background:The Boditech iCHROMA™ point of care immunoassay analyser has a Covid-19 antibody assay for the qualitative determination of IgG/IgM antibodies in human whole blood/serum/plasma. It is helpful as an aid in the screening of early mild asymptomatic or acute patients for identifying Covid-19 infection with high sensitivity.Objectives: To determine the clinical agreement (sensitivity and specificity) of the Boditech iCHROMA™ Covid-19 antibody assay and the Abbott Architect SARS-CoV-2 IgG assay for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma.Results: Of the 50 plasma samples, 20 (40%) of the plasma samples assayed were reported as positive by both the Abbott Architect SARS-CoV-2 IgG assay and the Boditech iCHROMA™ Covid-19 IgG antibody assay. The remaining 30 (60%) of the plasma samples were reported as negative by Abbott Architect SARS-CoV-2 IgG antibody assay. However, the Boditech iCHROMA™ Covid-19 IgG antibody assay, reported only 27 of the 30 (90%) samples as negative. Conclusion:There was an overall agreement of 95%, with a sensitivity of 100% and a specificity of 90% of the Boditech iCHROMA™ Covid-19 IgG antibody assay and the Abbott Architect SARS-CoV-2 IgG assay.
We are developing an immune sensor for early detection of breast cancer and its recurrence in blood, based on identifying the earliest specific changes/alterations in the immuno-biochemical signals in different immune components that are distinctly different from those in a healthy immune system. The screening of different immuno-biochemical signals in their native and altered forms in different immune components/cells led to identification of a novel T cell population. Analysis of this T cell population and its immuno-biochemical signals on blood samples from the 4 groups - (i) healthy, (ii) recently diagnosed with invasive breast cancer stage 1{before the onset of treatment/surgery}, (iii) breast cancer treated individuals who had incidence of recurrence/relapse {BCR}, and (iv) breast cancer treated individuals who were disease free {BDF}- was done using multi-parameter flow cytometry. Sixteen molecules, assessed as the most likely candidates for sensing disruptions in the immune pathway, were used in developing a matrix. Care was taken to separate subjects that could confound the immuno-biochemical signals, potentially arising from other immune disorders. The method designed is different from conventional approaches and has the potential to be used as a cost-effective assessment to predict health status.
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