Clinical evaluation of serological IgG antibody response on the Abbott Architect for established SARS-CoV-2 infection

• DOI: 10.1016/j.cmi.2020.05.036
• Publication Date: 2020-06-09T15:43:48Z
• Authors: K.L. Chew; S.S. Tan; S. Saw; A. Pajarillaga; S. Zaine; C. Khoo; W. Wang; P. Tambyah; R. Jureen; S.K. Sethi
• Keywords: Microbiology (medical); 0301 basic medicine; Singapore; Time Factors; Abbott Architect; SARS-CoV-2; 610; COVID-19; General Medicine; Antibodies, Viral; Sensitivity and Specificity; Antibodies; COVID-19 Serological Testing; 3. Good health; 03 medical and health sciences; Serology; Infectious Diseases; Immunoglobulin G; 616; Antibody Formation; Humans; Original Article; Viral

This study aimed to evaluate the diagnostic performance of the Abbott Architect SARS-CoV-2 IgG assay in COVID-19 patients.Residual sera from 177 symptomatic SARS-CoV-2-positive patients and 163 non-COVID-19 patients were tested for antibody with the Abbott SARS-CoV-2 IgG assay (Abbott Diagnostics, Chicago, USA). Clinical records for COVID-19 patients were reviewed to determine the time from onset of clinical illness to testing.Specificity of the assay was 100.0% (95%CI: 97.1-100.0%). The clinical sensitivity of the assay varied depending on time from onset of symptoms, increasing with longer periods from the onset of clinical illness. The clinical sensitivity at ≤6 days was 8.6% (7/81; 95%CI: 3.8-17.5%), at 7-13 days 43.6% (17/39; 95%CI: 28.2-60.2%), at 14-20 days 84.0% (21/25; 95%CI: 63.1-94.7%), and at ≥21 days 84.4% (27/32; 95%CI: 66.5-94.1%). Clinical sensitivity was higher in the ≥14-day group compared to <14 days. There were no differences between the 14-20-day and ≥21-days groups; the combined clinical sensitivity for these groups (≥14 days) was 84.2% (49/57; 71.6-92.1%).The Abbott SARS-CoV-2 IgG test has high specificity. Clinical sensitivity was limited in the early stages of disease but improved from 14 days after the onset of clinical symptoms.