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2015 ; 100
(8
): E1074-83
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English Wikipedia
Thyroglobulin (Tg) Testing Revisited: Tg Assays, TgAb Assays, and Correlation of
Results With Clinical Outcomes
#MMPMID26079778
Netzel BC
; Grebe SK
; Carranza Leon BG
; Castro MR
; Clark PM
; Hoofnagle AN
; Spencer CA
; Turcu AF
; Algeciras-Schimnich A
J Clin Endocrinol Metab
2015[Aug]; 100
(8
): E1074-83
PMID26079778
show ga
CONTEXT: Measurement of thyroglobulin (Tg) by mass spectrometry (Tg-MS) is
emerging as a tool for accurate Tg quantification in patients with anti-Tg
autoantibodies (TgAbs). OBJECTIVE: The objective of the study was to perform
analytical and clinical evaluations of two Tg-MS assays in comparison with
immunometric Tg assays (Tg-IAs) and Tg RIAs (Tg-RIAs) in a cohort of thyroid
cancer patients. METHODS: A total of 589 samples from 495 patients, 243 TgAb-/252
TgAb+, were tested by Beckman, Roche, Siemens-Immulite, and Thermo-Brahms Tg and
TgAb assays, two Tg-RIAs, and two Tg-MS assays. RESULTS: The frequency of TgAb+
was 58%, 41%, 27%, and 39% for Roche, Beckman, Siemens-Immulite, and
Thermo-Brahms, respectively. In TgAb- samples, clinical sensitivities and
specificities of 100% and 74%-100%, respectively, were observed across all
assays. In TgAb+ samples, all Tg-IAs demonstrated assay-dependent Tg
underestimation, ranging from 41% to 86%. In TgAb+ samples, the use of a common
cutoff (0.5 ng/mL) for the Tg-MS, three Tg-IAs, and the USC-RIA improved the
sensitivity for the Tg-MSs and Tg-RIAs when compared with the Tg-IAs. In up to
20% of TgAb+ cases, Tg-IAs failed to detect Tg that was detectable by Tg-MS. In
Tg-RIAs false-high biases were observed in TgAb+ samples containing low Tg
concentrations. CONCLUSIONS: Tg-IAs remain the method of choice for Tg
quantitation in TgAb- patients. In TgAb+ patients with undetectable Tg by
immunometric assay, the Tg-MS will detect Tg in up to 20% additional cases. The
Tg-RIA will detect Tg in approximately 35% cases, but a significant proportion of
these will be clinical false-positive results. The undetectable Tg-MS seen in
approximately 40% of TgAb+ cases in patients with disease need further
evaluation.
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