Wyss Validation Study SARS-CoV-2
The results of the validation study, conducted at the Wyss Institute for Biologically Inspired Engineering at Harvard University, are a significant milestone.
Among the major findings it was reported:
- The SARS-CoV-2 Antibody biosensor assay was 100% sensitive and 100% specific using clinical COVID-19 positive and negative SARS CoV-2 human samples.
- The time in obtaining results was less than 10 minutes.
The study is the first step towards the validation of a rapid point-of-care diagnostic that LSBD intends to develop and commercialize for the quantitative measurement of antibodies against SARS-CoV-2 in saliva. The company will now work with Johns Hopkins University to commence clinical trials.
"We are very excited with the outcome of this program and are eager to validate the test in saliva, there is evidence in recent scientific literature correlating IgG, IgM responses to spike and receptor-binding domain (RBD) in the serum positively correlated with matched saliva samples." Dr. George Syrmalis, Chief Executive Officer and Chairman of The iQ Group Global, said.
"This evidence confirms that serum and saliva IgG antibodies to SARS-CoV-2 are maintained in most COVID-19 patients for at least three months post symptom onset. Our objective is to deliver a SARS-CoV-2 test that is calibrated against the WHO reference preparation, non-invasive and easy to use by everyone."
"We anticipate two urgent applications for the technology including population screening with diagnosis as a complement to the RNA virus test for patients presenting late onset of symptoms; and post-vaccination screening to determine whether booster vaccines are required by assessing the degree of the antigen-specific antibody responses to a SARS-CoV-2 vaccine that's been administered." Dr. Syrmalis said.
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