Analytical and clinical evaluation of the light‐initiated chemiluminescent assays for measurement of human thyroid hormones. Issue 5 (21st March 2022)

• Record Type: Journal Article
• Authors: Li, Jing; Huang, Youyuan; Xiang, Guiming; Xu, Enjun; Chen, Tao; Yang, Ming; Zhang, Jie
• Is Part Of: Journal of clinical laboratory analysis. Volume 36:Issue 5(2022)
• Page Start: n/a
• Page End: n/a
• Publication Date: 2022-03-21
• Subjects: LiCA 800 analyzer -- light‐initiated chemiluminescent assay -- performance evaluation -- thyroid assay -- thyroid disease; Diagnosis, Laboratory -- Periodicals; Medical laboratory technology -- Periodicals; 616
• DOI: 10.1002/jcla.24266
• Languages: English
• ISSNs: 0887-8013

Abstract

Abstract: Background: Light‐initiated chemiluminescent assay (LiCA) is a new homogeneous immunoassay. The aim of this study was to evaluate the analytical and clinical performance of the assays for the detection of thyroid hormones based on the fully automated LiCA 800 analyzer. Methods: Analytical validations of the LiCA thyroid assays (TSH, FT3, FT4, T3, and T4) included precision, linearity, analytical sensitivity, interference, and method comparison applying the protocols of the Clinical and Laboratory Standards Institute (CLSI). The diagnostic performance was assessed by the receiver operating characteristic (ROC) curve analysis with different assay schemes for the diagnosis of hyperthyroidism and hypothyroidism. Results: Within‐run and within‐lab precisions (%CV) of the five assays ranged from 1.06 to 6.40% at all concentrations evaluated. A satisfactory linearity was verified over the entire measuring range for TSH, T3, and T4 ( R > 0.99, change in recovery <10%, p = 0.000 all). Paired‐comparison measurements presented a comparable assay for each of the five assays ( R > 0.96, median bias <5%, p < 0.0001 all) between LiCA and Cobas across three institutes. The diagnostic accuracy of the LiCA assays for hyperthyroidism or hypothyroidism was quantified by the areas under curves (AUC) as 0.925 or 0.832 with the five‐assay panel (TSH, FT3, FT4, T3, and T4) and as 0.921 or 0.811 with the three‐assay panel (TSH, FT3, and FT4), respectively. No significant difference was found between the AUC of LiCA and that of DxI, Cobas, or Centaur ( p > 0.3 all). Conclusion: LiCA 800 provides a precise and high‐throughput immunoassay platform for detection of thyroid hormones. It is acceptable for clinical use. Abstract : In this study, we have validated the analytical and diagnostic performance of the LiCA thyroid assays. Paired‐comparison measurements demonstrated a reasonable concordance for each of the assays ( R > 0.96, median bias <5%, p < 0.0001 all) between LiCA and Cobas across three institutes. To further characterize the clinical performance of the LiCA assays for the diagnosis of hyperthyroidism and hypothyroidism, we compared the AUCs with the five‐assay panel (TSH, FT3, FT4, T3, and T4) and with the three‐assay panel (TSH, FT3, and FT4) between LiCA and other three commonly used methods (DxI, Cobas, and Centaur). No significant difference was found ( p > 0.3 all), and this confirmed the diagnostic accuracy and applicable in clinical practice of the LiCA thyroid assays.