Samples spiked with pituitary-derived thyroid-stimulating hormone may disguise the extent of differences between thyroid-stimulating hormone assays.

Abbott Roche Thyroid-stimulating hormone WHO International Standard for thyroid-stimulating hormone assay discordance external quality assessment

Journal

Annals of clinical biochemistry
ISSN: 1758-1001
Titre abrégé: Ann Clin Biochem
Pays: England
ID NLM: 0324055

Informations de publication

Date de publication:
11 2021
Historique:
pubmed: 18 9 2021
medline: 14 1 2022
entrez: 17 9 2021
Statut: ppublish

Résumé

A large discordance in the diagnosis and potential management of hypothyroidism using Abbott and Roche thyroid assays has been reported recently. The difference in Abbott and Roche thyroid-stimulating hormone (TSH) results in these studies was larger than anticipated from the external quality assessment (EQA) reports. Abbott and Roche TSH method means in UK NEQAS for thyroid hormones distributions 430 to 454 were compared against the amount of TSH spiked. A TSH deplete serum pool was spiked with various concentrations of pooled high TSH serum and 3rd WHO International Standard for TSH (WHO-IS). Four serum pools with TSH close to clinical decision limits were spiked with two concentrations of WHO-IS. On review of EQA data, median (IQR) Roche: Abbott TSH ratio was lower ( Abbott and Roche TSH assays are not in harmony in human serum samples but the agreement was better in samples spiked with WHO-IS which contains pituitary-derived TSH. Use of pituitary-derived TSH spiked samples, such as provided by EQA schemes, may mask clinically significant between-assay differences.

Sections du résumé

BACKGROUND
A large discordance in the diagnosis and potential management of hypothyroidism using Abbott and Roche thyroid assays has been reported recently. The difference in Abbott and Roche thyroid-stimulating hormone (TSH) results in these studies was larger than anticipated from the external quality assessment (EQA) reports.
METHODS
Abbott and Roche TSH method means in UK NEQAS for thyroid hormones distributions 430 to 454 were compared against the amount of TSH spiked. A TSH deplete serum pool was spiked with various concentrations of pooled high TSH serum and 3rd WHO International Standard for TSH (WHO-IS). Four serum pools with TSH close to clinical decision limits were spiked with two concentrations of WHO-IS.
RESULTS
On review of EQA data, median (IQR) Roche: Abbott TSH ratio was lower (
CONCLUSION
Abbott and Roche TSH assays are not in harmony in human serum samples but the agreement was better in samples spiked with WHO-IS which contains pituitary-derived TSH. Use of pituitary-derived TSH spiked samples, such as provided by EQA schemes, may mask clinically significant between-assay differences.

Identifiants

pubmed: 34533384
doi: 10.1177/00045632211042560
doi:

Substances chimiques

Thyroid Hormones 0
Thyrotropin 9002-71-5

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

638-645

Auteurs

Tejas Kalaria (T)

New Cross Hospital, Black Country Pathology Services, 592016The Royal Wolverhampton NHS Trust, Wolverhampton, UK.

Jonathan Fenn (J)

New Cross Hospital, Black Country Pathology Services, 592016The Royal Wolverhampton NHS Trust, Wolverhampton, UK.

Hayley Sharrod-Cole (H)

New Cross Hospital, Black Country Pathology Services, 592016The Royal Wolverhampton NHS Trust, Wolverhampton, UK.

Anna Sanders (A)

Russells Hall Hospital, Black Country Pathology Services, 592016The Royal Wolverhampton NHS Trust, Dudley, UK.

Clare Ford (C)

New Cross Hospital, Black Country Pathology Services, 592016The Royal Wolverhampton NHS Trust, Wolverhampton, UK.

Rousseau Gama (R)

New Cross Hospital, Black Country Pathology Services, 592016The Royal Wolverhampton NHS Trust, Wolverhampton, UK.
School of Medicine and Clinical Practice, University of Wolverhampton, Wolverhampton, UK.

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