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Submitted on March 28, 2005
Accepted on June 21, 2005
Department of Medicine, Division of Endocrinology, Keck School of Medicine, University of Southern California. Southern California Permanente Medical Group, Los Angeles
Context: Changes in Tg and/or TgAb methods can disrupt the serial monitoring of DTC patients.
Objective: This study compared Tg measurements made in TgAb-negative and TgAb-positive sera using four RIA and ten IMA methods.
Design: TgAb detection using a panel of twelve direct methods was contrasted with four Tg recovery tests. Sera from 110 normal euthyroid subjects (68 TgAb-negative/42 TgAb-positive) and 131 TgAb-negative DTC patients had Tg and/or TgAb analyses made by ten laboratories in four countries. Euthyroid controls were used to compare Tg and TgAb ranges, sensitivities and TgAb interference, whereas DTC patients were used to study Tg assay specificities, hook effects and the influence of high Tg on TgAb measurements.
Results: Tg methods had high between-method variability [47 ± 3 (SEM) %CV] that was only marginally reduced by CRM-457 standardization [37 ± 3%]. All methods had suboptimal sensitivity and some failed to detect Tg in some normal euthyroid controls. Although direct TgAb measurements were more reliable than exogenous recovery tests, TgAb status was only concordant in 65% of sera. Only 4/42 (9.5%) sera containing TgAb had antibody detected by all direct methods. All IMA methods reported paradoxically undetectable Tg for many TgAb-positive euthyroid controls suggesting TgAb interference, whereas RIA methods reported appropriate normal range values for these same subjects. Some sera displaying interference had TgAb detected by only a minority of methods.
Conclusions: Specificity differences, suboptimal sensitivity, hook effects and an inability to reliably detect interfering TgAb compromise the clinical utility of current Tg and TgAb methods. All of the IMA methods were prone to underestimate serum Tg in the presence of TgAb, whereas the RIA methods appeared resistant to TgAb interference.
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