Effective today, May 19, 2020, the University of Iowa Hospitals and Clinics Core Laboratory will begin offering testing for antibodies to SARS-CoV-2, the novel coronavirus that causes COVID-19. Details on the new assay are as follows:

• COVID-19 (Novel Coronavirus) Serology, Total Antibodies (LAB9019)
• Roche Diagnostics assay for total antibodies to SARS-CoV-2. All specimens positive by the Roche assay are tested by a separate DiaSorin SARS-CoV-2 IgG assay.
• Specimen Type: Plasma separator tube (Hospital Stores # 907695)
• Test Result Availability: within 24 hours of specimen receipt in the laboratory

The Roche and DiaSorin 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. The Roche assay targets the nucleocapsid (N) antigen. The DiaSorin assay targets the S1 and S2 subunits of the spike (S) glycoprotein. The use of these two complementary assays is intended to limit false positives given the unknown prevalence in our community.

Order entry prompts for this testing will emphasize the intended use and limitations:

1. This test cannot be used to diagnose acute (within 2 weeks of symptoms onset) infection with SARS-CoV-2. The appropriate test for this is NOVEL CORONAVIRUS (COVID-19) [LAB8963].
2. This test should be used to identify individuals previously infected with SARS-CoV-2 (more than two weeks from onset of illness).
3. This test cannot determine if a patient has developed protective immunity. Thus, the results of this test should not be used to guide PPE use or adherence to physical distancing practices.

Ordering of serological testing is currently unrestricted and adherence to SHL/IDPH guidelines for ordering serological testing is not required.

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