Comparison of turnaround time (TAT) performance between Enzyme-Linked Immunosorbent Assay (ELISA) vs. Automated Chemiluminescent Immunoassay (CLIA) in measuring diabetes autoantibodies

Abstract

Autoantibodies to glutamate decarboxylase (GAD), islet antigen-2 (IA2) and islet cell antigen (ICA) are characteristic markers for type 1 diabetes among paediatric populations and adults with latent autoimmune diabetes. We aim to compare the analysis performance of the enzyme-linked immunosorbent assay (ELISA) and the chemiluminescence immunoassay (CLIA) methods in the detection of diabetes autoantibodies. A cross-sectional study was conducted on 1,425 serum samples sent for diabetes autoantibodies measurement at the Institute for Medical Research, Kuala Lumpur, Malaysia, from April 2021 to July 2022. A total of 695 samples were measured using the Medizym® ELISA kit 96 wells and 730 samples were measured using Maglumi® CLIA kit. Both methods were able to produce timely results at more than 90% of the allowable laboratory turnaround time (LTAT). Cohen’s kappa showed good and satisfactory agreement between the two methods: 0.734 (GAD), 0.413 (ICA), 0.514 (IA2). Additionally, the CLIA method was significantly less time-consuming and less labour-intensive. CLIA method has a significant advantage over ELISA in offering better laboratory workflow with shorter time testing and TAT in laboratory practice.