Can newer assay methods improve the prediction of type 1 diabetes mellitus (T1DM) risk in at-risk individuals? An observational analysis published in Diabetic Medicine evaluated whether a luciferase immunoprecipitation system (LIPS) assay enhances insulin autoantibody (IAA)-based risk assessment compared with the standard micro-radiobinding assay (RBA).
The study included samples from 150 individuals with new-onset T1DM and 619 first-degree relatives (FDRs). Among FDRs, 91 developed diabetes during follow-up. Cross-sectional data were analyzed using the area under the receiver operating characteristic curve and Cox proportional hazards models. The analysis compared IAA detection by LIPS and RBA and assessed associations with diabetes risk.
In new-onset T1DM, LIPS and RBA showed 88% agreement in IAA status. Among FDRs, positive IAA by LIPS was more frequent in those with high- to moderate-affinity IAA (61%) compared with low-affinity IAA (18%) (p <0.001). In FDRs positive for multiple other islet autoantibodies, 20-year diabetes risk was 80% for those positive by LIPS and 30% for those negative (p = 0.013). LIPS provided additional risk information independent of IAA status by RBA, other autoantibodies, and age at sampling (p <0.001).
These findings show that the LIPS assay identified individuals at higher risk of T1DM beyond standard IAA measurement.