Document Detail

Discrepancies between thyrotropin (TSH) measurement by four sensitive immunometric assays.
MedLine Citation:
PMID:  9086299     Owner:  NLM     Status:  MEDLINE    
A comparison of four different commercial immunometric thyrotropin (TSH) assays (Amerlite R TSH-30 Ultrasensitive assay from Kodak, BeriLux R hTSH from Behring Werke, Delfia R hTSH Ultra from Wallac and IMX R Ultrasensitive hTSH from Abbott) was made by measuring serum TSH in 81 consecutive patients referred to hospital for various reasons with a serum TSH less than 0.8 mlU/l in the IMX assay. The analytical and functional assay sensitivities of each of the assays were analysed. Even though three of the methods had a sensitivity corresponding to third generation assays, we could only demonstrate an overall agreement of serum TSH when comparing two of the kits. The measurements in Delfia Ultra and Berilux showed good agreement (P = 0.7, paired t-test and bias = 0.003 mIU/l), while the comparisons between the other assays showed different measurements (P < 0.00001, paired t-test and bias more than 0.07 mIU/l). Differences in the calibrators used in the assays might explain some of the discrepancy, although all methods were calibrated according to the same international standard. Also, differences in the specificity of the TSH monoclonal antibodies used in the assays might be an evident explanation and further studies of the specificity of the monoclonal antibodies are needed. An international collaborative study to clarify reasons for the differences between the TSH assays and to standardize the measurements is recommended.
A K Rasmussen; L Hilsted; H Perrild; E Christiansen; K Siersbaek-Nielsen; U Feldt-Rasmussen
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Publication Detail:
Type:  Comparative Study; Journal Article    
Journal Detail:
Title:  Clinica chimica acta; international journal of clinical chemistry     Volume:  259     ISSN:  0009-8981     ISO Abbreviation:  Clin. Chim. Acta     Publication Date:  1997 Mar 
Date Detail:
Created Date:  1997-06-17     Completed Date:  1997-06-17     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  1302422     Medline TA:  Clin Chim Acta     Country:  NETHERLANDS    
Other Details:
Languages:  eng     Pagination:  117-28     Citation Subset:  IM    
Medical Department P2131, Rigshospitalet, Copenhagen, Denmark.
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MeSH Terms
Aged, 80 and over
Immunoradiometric Assay
Middle Aged
Reagent Kits, Diagnostic*
Sensitivity and Specificity
Thyrotropin / blood*
Reg. No./Substance:
0/Reagent Kits, Diagnostic; 9002-71-5/Thyrotropin

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