MGH Core Laboratory SARS-CoV-2 Antibody Testing

On Tuesday June 9, 2020 SARS-CoV-2 antibody testing was made available in the MGH Core Laboratory.  The test is the Roche SARS-CoV-2 total antibody test.  The Roche assay is an FDA EUA approved test with >99% specificity and >90% sensitivity 14 days post symptom onset.  The test is a qualitative assay for total anti-SARS CoV-2 antibodies, detecting IgG, IgM, and IgA antibodies.  The results are reported as Negative or Positive.  A positive result indicates that the sample was reactive for anti-SARS-CoV-2 antibodies.

The detailed MGB guidelines for SARS-CoV-2 antibody test ordering and result interpretation are available on the MGB Pulse site: https://pulse.partners.org/hub/departments/emergency_preparedness/coronavirus/covid19_clinical_policies/antibody_testing_for_covid19

Testing indications:

–Hospitalized patients (unchanged from prior):

SARS-CoV-2 antibody may be useful for hospitalized patients with at least 7 days of a clinical syndrome compatible with COVID-19 but one or more negative COVID-19 PCR tests.

–Ambulatory patients (new 6/9/2020):

SARS-CoV-2 antibody tests can be used: 1) as an aid to diagnosis in patients with syndromes compatible with COVID-19 AFTER negative PCR testing or 2) to test asymptomatic patients for evidence of prior infection.

The order is available in Epic on both the inpatient and ambulatory facility lists (LAB407438, SARS-CoV-2 antibody, total).  The testing requires a Gold top serum tube and will be performed several times per week.  Further information, including FDA Fact sheets are available in the MGH Laboratory Handbook (http://epath.partners.org/test/MGH/20316).  For comments or questions please contact Anand Dighe, Director, MGH Core Laboratory.