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

Nadirah Zainal Abidin^1,3*, Raja Hasyidah Raja Bongsu¹, Karniza Khalid², Nor Daliza Mohd Razali¹, Stefannie Micheal Johnson¹, Vaanhi Sandran¹, Yuslina Mat Yusoff³, Saraswathy Apparow¹

1. Endocrine Unit, Specialised Diagnostic Center, Institute for Medical Research, National Institutes of Health, Ministry of Health, Setia Alam, 40170, Shah Alam, Selangor Malaysia
2. Special Protein Unit, Specialised Diagnostics Center, Institute for Medical Research, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170, Shah Alam, Selangor Malaysia
3. Haematology Unit, Cancer Research Center, Institute for Medical Research, National Institutes of Health, Ministry of Health Malaysia, Setia Alam, 40170, Shah Alam, Selangor Malaysia

*Corresponding author: Nadirah Zainal Abidin. This email address is being protected from spambots. You need JavaScript enabled to view it.. my. Tel: +603-33628583

CITATION: Zainal Abidin N, Raja Bongsu RH, Khalid K, Mohd Razali ND, Micheal Johnson S, Sandran V, et al. Comparison of turnaround time (TAT) performance between Enzyme-Linked Immunosorbent Assay (ELISA) vs. Automated Chemiluminescent Immunoassay (CLIA) in measuring diabetes autoantibodies. International Medical Research Journal. 2025 May 30;11(1):77–83. https://doi.org/10.63719/imrj.2025.11.01.007 

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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.

KEYWORDS: method comparison, ELISA, CLIA, diabetes autoantibodies