ArticleJournal of clinical laboratory analysis2022
Analytical and clinical evaluation of the light-initiated chemiluminescent assays for measurement of human thyroid hormones.
Article in Journal of clinical laboratory analysis, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
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Who cites it
4 citing papers in PubMed, 6 citations in OpenAlex.
- Analytical and Workflow Performance of a High-Throughput Chemiluminescent Immunoassay System in a Clinical Laboratory.Journal of clinical laboratory analysis · 2026Article
- Beyond iodine nutrition: socioeconomic patterns independently drive thyroid disease risk in pregnant women in Xinjiang.Frontiers in nutrition · 2026Article
- Application Value of Chemiluminescence Immunoassay in Thyroid Function Biochemical Testing.Journal of fluorescence · 2025Article
- Analytical and clinical evaluation of the light-initiated chemiluminescent assays for measurement of human thyroid hormones.Journal of clinical laboratory analysis · 2022Article
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Authors and funding
7 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLight-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.
methodsAnalytical 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.
resultsWithin-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).
conclusionLiCA 800 provides a precise and high-throughput immunoassay platform for detection of thyroid hormones. It is acceptable for clinical use.
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