An Update On Our Validation Study
Friends,
Several weeks ago, I posted a Call to Action asking for volunteers to contribute to a validation study for our antibody assay. The response was overwhelmingly positive. We have now enrolled over 150 people from across the country into our study. With all your help, we are so close to finalizing our validation study - we just need a few more local participants, we will mail you a kit! Sign up here: SARS CoV 2 Donors
Today, I am thrilled to share an update on our progress towards developing new tests to help fight against the COVID-19 pandemic. Several weeks ago, we submitted our application packet to the FDA for a serum-based antibody assay. Our test is extremely highly performing, with 100% sensitivity in samples collected after 15 days from disease onset and 99.59% specificity, squarely placing our platform in the upper echelon of testing technologies. We will let you know as soon as we hear from the FDA.
Over the weekend, we issued a pre-print on another advance: at-home collection of blood spots for antibody testing. We developed a kit that can be sent through the mail to the homes of people who wish to be tested. This kit contains lancets to prick your finger and deposit blood onto a piece of filter paper which, when dried, can be sent back to our labs in South San Francisco for analysis. This methodology allows people to get a high-quality test performed by laboratory professionals from the safety of their own home. In fact, with the fully-volunteer cohort we have tested so far, we report 100% accuracy of the test, even for kits sent in from as far as the east coast!
We expect that this at-home collection will permit testing of people who do not have access to medical facilities due to distance, lack of means of transportation, disability, or desire to avoid unneeded exposure to infection. We are in early discussions with the FDA to gain approval for the collection kit and lab protocols.
Our deepest thanks goes to all of the participants and we will continue to keep you updated as we progress!
-Peter
