Long-term stability of thyroid peroxidase antibody (anti-TPO) in serum in the Danish General Suburban Population Study

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We evaluated the long-term stability of thyroid peroxidase antibody (anti-TPO). In the Danish General Suburban Population Study (GESUS), serum samples were biobanked at -80 °C during 2010-2013. In a paired design with 70 subjects, we compared anti-TPO (30-198 U/mL) measured on fresh serum on Kryptor Classic in 2010-2011 (anti-TPOfresh) with anti-TPO remeasured on frozen serum (anti-TPOfrozen) on Kryptor Compact Plus in 2022. Both instruments used the same reagents and the anti-TPOn automated immunofluorescent assay, which was calibrated against the international standard NIBSC 66/387, based on the Time Resolved Amplified Cryptate Emission (TRACE) technology from BRAHMS. Values greater than 60 U/mL are regarded as positive in Denmark with this assay. Statistical comparisons included Bland-Altman, Passing-Bablok regression, and Kappa statistic. The mean follow-up time was 11.9 years (SD: 0.43). For anti-TPOfrozen vs. anti-TPOfresh, the line of equality was within the confidence interval of the absolute mean difference [5.71 (-0.32; 11.7) U/mL] and the average percentage deviation [+2.22% (-3.89%; +8.34%)]. The average percentage deviation of 2.22% did not exceed analytical variability. Passing-Bablok regression revealed both a statistically significant systematic and proportional difference: Anti-TPOfrozen=-22.6 + 1.22∗(anti-TPOfresh). Frozen samples were correctly classified as positive in 64/70 (91.4%; Kappa=71.8%). Anti-TPO serum samples in the range 30-198 U/mL were stable after 12-years of storage at -80 °C with an estimated nonsignificant average percentage deviation of +2.22%. This comparison is based on Kryptor Classic and Kryptor Compact Plus, which used identical assays, reagents, and calibrator, but for which the agreement in the range 30-198 U/mL is unclarified.

OriginalsprogEngelsk
TidsskriftClinical Chemistry and Laboratory Medicine
Vol/bind61
Udgave nummer9
Antal sider7
ISSN1434-6621
DOI
StatusUdgivet - 2023

Bibliografisk note

Funding Information:
Research funding: The study received funding from the Danish Ministry of Health via a grant given to research of thyroid treatments in December 2018. The Danish Ministry of Health did not have any influence on any part of the study or manuscript. GESUS was funded by the Region Zealand Research Foundation, Naestved Hospital Foundation, Naestved Municipality, Johan and Lise Boserup Foundation, TrygFonden, Johannes Fog’s Foundation, Region Zealand, Naestved Hospital, The National Board of Health, The Local Government Denmark Foundation. None of these had any influence on any part of the study or manuscript. CE is partly funded by the Laboratory Medicine Endowment Fund of Boston Children’s Hospital.

Publisher Copyright:
© 2023 the author(s).

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