NCI Part of Federal Effort to Evaluate Antibody Tests for Novel Coronavirus
Article by the National Cancer Institute/Evaluating Antibody Tests for Novel Coronavirus
As part of a collaboration with the Food and Drug Administration (FDA) and several other government agencies and academic medical centers, NCI is evaluating commercially available antibody tests for SARS-CoV-2, the novel coronavirus that causes COVID-19.
NCI has already assessed several of the tests and has provided the findings to FDA.
While “cancer research and cancer care remain job number one at NCI,” said NCI Director Norman Sharpless, M.D., “NCI has unique research capabilities and capacities. So, to help in this public health crisis, we believe, is a moral obligation.”
Because of its robust research infrastructure, including expertise in human papillomavirus (HPV) vaccines and an advanced serology laboratory, part of NCI’s Frederick National Laboratory for Cancer Research (FNLCR) has shifted its focus to provide independent testing and validation of SARS-CoV-2 antibody tests.
Antibody tests, also called serology tests, can be used to identify whether individuals have antibodies against SARS-CoV-2 in their blood. Antibodies are proteins made by the immune system in response to an infection. If someone has antibodies to the virus, it means that the person is, or was, infected.
At the time of publication, FDA has authorized emergency use of twelve different antibody tests, but many more tests are available commercially that haven’t been reviewed by the agency. On May 4, the agency updated its earlier policy guidance on antibody tests for commercial test manufacturers related to emergency use authorizations and providing specific clinical performance expectations for these tests.
“With support from Congress, NCI is working with the FDA and other government agencies to rapidly and rigorously characterize the performance of serology assays,” said Douglas Lowy, M.D., NCI’s principal deputy director and a leading expert on HPV. The results of serology tests, along with other relevant information, such as a person’s clinical history or other diagnostic test results, “can help determine who in the community has had a prior COVID-19 infection,” Dr. Lowy said.
“Determining the next steps in our response to COVID-19 is partially dependent on an accurate assessment of our national efforts thus far, and the quality of data for making this decision is dependent on accurate testing products,” explained FDA Commissioner Stephen Hahn, M.D., in a statement.
Validated serology tests are also crucial for further studies of COVID-19, including studies of disease prevalence (called seroprevalence), immunity, and candidate vaccines, explained Ligia Pinto, Ph.D., who is leading the antibody testing work. Dr. Pinto directs FNLCR’s Vaccine, Immunity, and Cancer Program and the HPV Serology Laboratory, which develops, optimizes, and validates serology tests for HPV.