CHOC will be utilizing this test to determine how many patient-facing clinicians and staff in their emergency department have developed COVID-19 fighting antibodies. John Wilkerson, President of WytCote's Senior Care and Medical Solutions stated, "This coronavirus antibody test has been used successfully in other countries—utilizing a simple blood test—to identify antibodies specific to the COVID-19 virus. Antibody detection can help to identify individuals previously or recently infected, including those that may not present any symptoms."
Heading this effort at CHOC are Dr. Theodore Heyming, Medical Director of CHOC's emergency department and Dr. Terence Sanger, CHOC's Vice President of Research & Chief Scientific Officer. Dr. Sanger shared, "While COVID-19 antibody screening is in its infancy, CHOC Children's is pleased to help share data and contribute to this important conversation as the world's scientific community unites in a race toward universal testing, antiviral treatment, and the development of a vaccine in order to permit a scientifically-based return to normalcy."
During this study, participants will undergo rapid antibody serological testing for immunoglobin G (IgG) and immunoglobin M (IgM) against COVID-19 novel coronavirus through a simple finger prick—once per shift—with results available in three minutes. The study expects to enroll up to 250 subjects total, with about 100 participants being tested each day.
WytCote Inc has applied to the FDA for Emergency Use Authorization and to the FDA/CDC/NIH for independent validation. The test has not been reviewed by the FDA. It is for qualitative assessment of antibody only. The test results of this product are for reference only and are not the sole basis for diagnosis or to exclude SARS-CoV-2 infection or to inform infection status or treatment. The diagnosis should be confirmed in combination with clinical symptoms or other conventional testing methods. Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.