Framingham, MA, April 24, 2020…….Kephera Diagnostics has launched a new study aimed at collecting blood samples from volunteers at least 18 years of age who have been confirmed positive for COVID-19, for use in development of an antibody test for the virus. The new test will determine whether symptomatic as well as asymptomatic individuals have been infected with the virus that causes COVID-19 by detecting antibodies to specific fragments of the virus. Volunteers will be provided with a kit to collect a finger prick blood sample at home, which will be returned in a prepaid mailer to the company for use in test development.
The test under development is an ELISA and will rely on selected fragments of coronavirus proteins that are recognized and bound by IgG and IgM antibodies in patient serum. Kephera scientists have identified sensitive and specific antibody targets within the virus causing COVID-19 using a combination of bioinformatics, laboratory experimentation, and experience in development of similar tests for the original SARS virus that caused an outbreak in 2003-4. The test is intended to provide quantitative as well as qualitative results, indicating whether an individual was infected with COVID-19 and if so, the levels of their IgG and IgM antibodies. Individuals who are asymptomatic or who had symptoms but may not have been diagnosed with COVID-19 are likely to have made antibodies which persist for some time after their infection resolves, and these antibodies can be detected using a sufficiently sensitive and specific antibody test. However, the levels of antibody in COVID-19 patients appear to be low in many cases, making them more challenging to detect, which is why a highly sensitive test is needed.
An important, emerging question is whether individuals who have antibodies to the virus that causes COVID-19 have acquired protective immunity. To answer this question, tests which can accurately measure the levels of IgG and IgM antibodies quantitatively in blood samples are needed. The test that we are developing will enable such quantitation and may eventually be useful in determining whether an individual has a high enough level of antibodies to be considered immune to re-infection. While the current study is aimed at supporting test development, Kephera expects to make the COVID-19 antibody tests available for diagnostic use through its laboratory once they are approved.