Effective today, May 4, 2021, the University of Iowa Hospitals and Clinics Core Laboratory will update testing for antibodies to SARS-CoV-2, the novel coronavirus that causes COVID-19.  Details on the new testing strategy are as follows:

• New order panel COVID-19 TOTAL ANTIBODIES SCREEN contains two tests, COVID-19 Total Antibodies Serology (Anti-Nucleocapsid) [LAB9019] and COVID-19 Total Antibodies Serology (Anti-Spike) [LAB9101], both from Roche Diagnostics.  Both tests will be performed when ordered in the panel.
• Positive results using the anti-nucleocapsid (N) assay are expected from natural infection, but not from vaccination alone.
• Positive results using the anti-spike (S) assay are expected from either natural infection or vaccination.  The semi-quantitative results reported by this assay should not be interpreted as an indication or degree of immunity.
• Antibody testing is not currently recommended to assess for immunity to COVID-19 following vaccination, nor is it recommended to assess the need for vaccination in an unvaccinated individual.
• Antibody responses may be suppressed in those with immune deficiencies and, rarely, in immunocompetent individuals.
• Order entry prompts, specimen type (plasma separator tube), and test result availability (within 4 hours of specimen receipt in the laboratory) have not changed.

The Roche serology assays have both been authorized by the FDA under an Emergency Use Authorization (EUA) for use by laboratories certified under CLIA to perform moderate or high complexity testing.

Questions should be directed to Matthew Krasowski, MD, PhD (384-9380, matthew-krasowski@uiowa.edu) or Anna Merrill, PhD (678-8400, anna-merrill@uiowa.edu).