“The IgM antibody response to the SARS-CoV-2 virus appears at days 5-6 after infection showing recent exposure to the virus, and lasts for up to three weeks, therefore it is an important test to increase the window of diagnostic sensitivity of true positive cases since the molecular test (nucleic acid test), despite being the gold standard, is not always positive in some patients during the early course of infection. The IgG antibody response peaks at day 21 and lasts for years, indicating the patient was infected with the virus. The Colloidal Gold IgM/IgG tests has become a very important test in the coronavirus testing paradigm, and we will be working to validate the assay here in the United States in the coming weeks in preparation for commercial launch under CLIA and parallel interactions with U.S. federal authorities to expedite its path to FDA approval using the recently enacted Emergency Use Authorization Program."

Because Colloidal Gold tests for antibodies to the virus that causes COVID-19 (SARS-CoV-2), instead of testing for the virus itself, this test will be different and complementary to the nucleic acid test Todos will be validating in parallel. 

Colloidal Gold demonstrated 90.4% sensitivity and 100% specificity in Chinese clinical trial 

Provides results in two to 10 minutes at the point of care using blood from a finger prick

https://investor.todosmedical.com/news-events...s-covid-19

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