A comparative evaluation between the Abbott Panbio™ COVID-19 IgG/IgM rapid test device and Abbott Architect™ SARS CoV-2 IgG assay

Abstract

Introduction Antibodies to SARS-CoV-2 serve as critical diagnostic markers for determining how broadly the COVID-19 pandemic has spread, confirming patient recovery, monitoring potential long-term effects of infection, and evaluating potential protection from reinfection. As new antibody tests become available, it is important to evaluate their performance and utility. The aim of this study was to compare the performance of the Abbott Panbio TM COVID-19 IgG/IgM Rapid Test Device against the Abbott Architect TM SARS CoV-2 IgG Assay for the detection of the COVID-19 IgG antibody. Methods Two panels of specimens were utilized to challenge both antibody tests: (1) a set of 150 prepandemic negative specimens collected in 2014, and (2) a set of 122 specimens from 87 hospitalized COVID-19 patients in the US and UK that were confirmed with a positive SARS-CoV-2 RNA test result. Results The Architect TM test had a specificity of 100 % and sensitivity of 99.1 % and 93.9 % when excluding or including immunocompromised patients, respectively for specimens collected >14 days post symptom onset or >5 days post-RNA testing. The Panbio TM test had 99.3 % agreement to Architect TM . Notably, N = 6 immune-compromised individuals were identified that did not develop detectable antibodies by day 30. Conclusion There is good concordance between the Architect TM SARS CoV-2 IgG Assay and Panbio TM COVID-19 IgG/IgM Rapid Test Device for the detection of SARS CoV-2 IgG.

Large-scale IgM and IgG SARS-CoV-2 serological screening among healthcare workers with a low infection prevalence based on nasopharyngeal swab tests in an Italian university hospital: Perspectives for public health

“…Thus, serological tests did not adequately indicate SARS-CoV-2 infection in patients with a previous positive NST result (IgM and IgG sensitivity of 27.78% and 50.00%, respectively). These results are in contrast to those from Batra and colleagues ( Batra et al, 2020 ), who found that the test had a specificity of 100% and sensitivity of 99.1% for specimens collected >14 days post symptom onset or >5 days post-RNA testing. On the other hand, Meschi et al (2020) showed that the Abbott system could have lower sensitivity, which is more similar to our results (61.9% on the fourteenth day).…”

Assesment of SARS-CoV-2 infection-in dentists and supporting staff at a university dental hospital in Argentina

“…There are now commercial serologic tests (immunochromatography) available, which are performed with whole blood and could be useful for diagnosis. 21 …”

Evaluation of the Abbott Architect, Roche Elecsys and Virtus S1 SARS-CoV-2 antibody tests in community-managed COVID-19 cases

“…Further reported sensitivities for the Abbott test are 99.1% in hospitalised patients(8), 97.9% in a mix of hospitalised patients and infected healthcare workers(9), 100% in patients, the vast majority of whom were hospitalised(10), 100 % in sera from patients whose disease severity was not specified(11) and 84.2% in patients admitted to a Singapore hospital, all of whom had respiratory symptoms and/or fever, but disease severity was not further reported(12). Reported sensitivities for the Roche test are 98.3% in sera from mostly hospitalised patients(13).…”