About all I can say about this is, what does "urgent" mean? Certainly hasn't happened in the many decades since diogenes did his test development. Yet every company and researcher involved has had the opportunity to at least try to go in the direction of standardisation.
O - and has anyone ever seen guidelines that properly refer to lab reference ranges rather than either the authors' own lab or some theoretical standardised ranges?
Ann Clin Biochem. 2017 Jan 1:4563217691549. doi: 10.1177/0004563217691549. [Epub ahead of print]
ANNALS EXPRESS: Comparison of method related reference intervals for thyroid hormones: studies from a prospective reference population and a literature review.
Barth JH1, Luvai A2, Jassam N3, Mbagaya W4, Kilpatrick ES5, Narayanan D2, Spoors S6.
1Leeds General Infirmary.
2Hull Royal Infirmary.
3Leeds Teaching Hospital Trust.
4Leeds Teaching Hospitals NHS Trust.
5Sidra Medical and Research Center.
6Doncaster and Bassetlaw Hospitals NHS Foundation Trust.
Introduction Reference intervals are dependent on the reference population, the analytical methods and the way the data is handled statistically. Individual method related differences have been studied but the comparative differences in reference intervals have not.
We studied a reference population of healthy adult subjects and measured free thyroxine and TSH by the four most commonly used analytical platforms used in the UK. Subjects were excluded if they were >65 years or had positive thyroid peroxidase antibodies. We also performed a systematic literature review of thyroid hormone reference interval studies in non-pregnant adults.
Results 303 subjects were recruited and 42 excluded. The central 95th centile values for TSH (miu/L) were Abbott Architect (0.51-3.67); Beckman Unicel DxI 0.57-3.60); Roche Cobas (0.60-4.31) and Siemens Advia Centaur XP (0.63-4.29). The 95th centile values values for thyroxine (pmol/L) were Abbott Architect (10.6-15.5); Beckman Unicel DxI (7.9-13.0); Roche Cobas (12.5-19.6) and Siemens Advia Centaur XP (11.8-19.0). We identified 55 papers describing thyroid reference intervals in male and non-pregnant female adults. The values for upper and lower reference intervals by manufacturer varied but were not significantly different for TSH but were for thyroxine.
Discussion Our study demonstrates clearly that there are marked variations in the reference intervals for thyroid hormones between analytical platforms. There is an urgent need for standardisation of thyroid hormone assays to permit transferability of results. Until then, guidelines will need to reflect this method related difference.