Diagnostic accuracy comparison of three fully automated chemiluminescent immunoassay platforms for the detection of SARS-CoV-2 antibodies

Abstract

Background: Serological test is an essential surveillance tool to track down the extensiveness of SARS-CoV-2 transmission and subsequently to move out from the enforced lockdown stage.

Objective: The study measures the diagnostic accuracy of three popular chemiluminescent immunoassay (CLIA) based automated platforms for the detection of anti-SARS-CoV-2 antibodies and compares their agreements.

Study design: Serum samples of 594 COVID-19 positive patients and 100 samples from pre-COVID cases were tested by three CLIA based automated platforms: Abbott architect i2000SR, Roche cobas e411 and Yhlo iFlash 1800 and their diagnostic accuracy were compared by the area under the curves (AUC) value obtained from receiver operator characteristic (ROC) curves. Cohen's kappa statistic and McNemar's test were used to interpret the agreement between the platforms.

Results: All three platforms showed high specificity as claimed by the manufacturer. Sensitivity was calculated as 64.48 % (58.67-70.3) for Abbott, 80.48 % (76.62-84.34) for Roche and 76.94 % (72.65-81.23) for Yhlo. AUC was maximum for Roche (0.929). The Cohen's kappa value was determined in between 0.69-0.89 as the inter-rater agreements.

Conclusion: The overall statistical analysis demonstrated cobas e411 as the diagnostically most accurate platform among the three.

Keywords: CLIA; Diagnostic comparison; SARS-CoV-2; Sensitivity; Specificity.