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Correct interpretation of thyroid function tests relies on correct reference intervals (RIs) for thyroid-stimulating hormone (TSH) and free thyroxine (FT4). ISO15189 mandates periodic verification of RIs, but laboratories struggle with cost-effective approaches. We investigated whether indirect methods (utilizing historical laboratory data) could replace the direct approach (utilizing healthy reference individuals) and compared results with manufacturer-provided RIs for TSH and FT4. We collected historical data (2008–2022) from 13 Dutch laboratories to re-establish RIs by employing indirect methods, TMC (for TSH) and refineR (for FT4). Laboratories used common automated platforms (Roche, Abbott, Beckman or Siemens). Indirect RIs (IRIs) were determined per laboratory per year and clustered per manufacturer (>1.000.000 data points per manufacturer). Direct RIs (DRIs) were established in 125 healthy individuals per platform. TSH IRIs remained robust over the years for all manufacturers. FT4 IRIs proved robust for three manufacturers (Roche, Beckman and Siemens), but the IRI upper reference limit (URL) of Abbott showed a decrease of 2 pmol/L from 2015. Comparison of the IRIs and DRIs for TSH and FT4 showed close agreement using adequate age-stratification. Manufacturer-provided RIs, notably Abbott, Roche and Beckman exhibited inappropriate URLs (overall difference of 0.5–1.0 µIU/mL) for TSH. For FT4, the URLs provided by Roche, Abbott and Siemens were overestimated by 1.5–3.5 pmol/L. These results underscore the importance of RI verification as manufacturer-provided RIs are often incorrect and RIs may not be robust. Indirect methods offer cost-effective alternatives for laboratory-specific or platform-specific verification of RIs. [ABSTRACT FROM AUTHOR]

Keywords: 24,25-dihydroxyvitamin D3; 25-hydroxyvitamin D; infantile idiopathic hypercalcemia; LC-MS/MS; reference values The ratio 25(OH)D/24,25(OH) SB 2 sb D was calculated using 25(OH)D SB 3 sb and 24,25(OH) SB 2 sb D SB 3 sb . To the best of our knowledge, this is the first time reference values for 24,25(OH) SB 2 sb D SB 3 sb and the 25(OH)D/24,25(OH) SB 2 sb D ratio have been established with a method standardized using the NIST SRM 972a reference material. In conclusion, using a newly developed and standardized LC-MS/MS assay, we have established reference values for the 25(OH)D/24,25(OH) SB 2 sb D ratio in both men and women, aged 20-71 years. [Extracted from the article]