Frank A. Quinn, Richard Scopp, Agnes Lach, Christopher Drake, May Mo, John Albright, Kevin Trimpe
A Comparison of Different Sample Matrices for Evaluating Functional Sensitivity, Imprecision and Dilution Linearity of the Abbott ARCHITECT® i2000® TSH Assay
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 ?IU/ml) and
TSH affinity-stripped (0.0038 ?IU/ml) sample matrices.
Assay imprecision was also independent of sample matrix,
with total imprecision ?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.
Clinical Chemical Laboratory Medicine, Walter de Gruyter
Print ISSN: 1434-6621
Volume: 40, 07/2002
Pages: 709 - 712
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