Document Detail

A comparison of different sample matrices for evaluating functional sensitivity, imprecision and dilution linearity of the Abbott ARCHITECT i2000 TSH assay.
MedLine Citation:
PMID:  12241019     Owner:  NLM     Status:  MEDLINE    
Important performance characteristics for any thyroid-stimulating hormone (TSH) assay include low-end sensitivity, precision across a wide dynamic range, and linear specimen dilution. Laboratories often characterize the performance of their TSH assay using many different sample matrices (e.g. native human serum, synthetic buffer, processed human serum, etc.). However, this can lead to possible confusion as the relationships between sample matrix and assay performance are often poorly understood. The purpose of our study was to evaluate the performance of the ARCHITECT i2000 TSH assay using a variety of different sample matrices. Functional sensitivity was found to be essentially equivalent in both hyperthyroid patient sera (0.0035 microIU/ml) and TSH affinity-stripped (0.0038 microIU/ml) sample matrices. Assay imprecision was also independent of sample matrix, with total imprecision < or = 5.3% for both synthetic buffer and serum matrices. Similarly, specimens were found to dilute linearly over a wide range in both serum and synthetic buffer matrices. We conclude that the i2000 TSH assay measures TSH similarly in a variety of sample matrices. This is an important design feature for this immunoassay which provides assurance that analytical performance assessed with matrices other than unprocessed human serum are representative of assay performance seen with patient specimens.
Frank A Quinn; Richard Scopp; Agnes Lach; Christopher Drake; May Mo; John Albright; Kevin Trimpe
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Publication Detail:
Type:  Comparative Study; Evaluation Studies; Journal Article    
Journal Detail:
Title:  Clinical chemistry and laboratory medicine : CCLM / FESCC     Volume:  40     ISSN:  1434-6621     ISO Abbreviation:  Clin. Chem. Lab. Med.     Publication Date:  2002 Jul 
Date Detail:
Created Date:  2002-09-20     Completed Date:  2003-07-01     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9806306     Medline TA:  Clin Chem Lab Med     Country:  Germany    
Other Details:
Languages:  eng     Pagination:  709-12     Citation Subset:  IM    
Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064, USA.
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MeSH Terms
Chemiluminescent Measurements
Immunoassay / methods*,  standards
Indicators and Reagents
Reproducibility of Results
Sensitivity and Specificity
Thyrotropin / blood*
Reg. No./Substance:
0/Indicators and Reagents; 9002-71-5/Thyrotropin

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