Endocrinology and Metabolism

Original Article

Comparison of Ultrasensitive and Highly Sensitive Assay to Predict Stimulated Thyroglobulin Levels Using Unstimulated Levels in Differentiated Thyroid Cancer Patients: Jinsun Jang, Hyun Joo Kim, Seunggyun Ha, Kyong Yeun Jung, Gyeongseo Jung, Sun Wook Cho, Do Joon Park, Gi Jeong Cheon, Young Joo Park; Received January 6, 2025 Accepted March 20, 2025 Published online June 5, 2025; DOI: https://doi.org/10.3803/EnM.2025.2302 [Epub ahead of print]

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Abstract PDF Supplementary Material PubReader ePub: Background
Thyroglobulin (Tg) measurement is an essential aspect of monitoring for differentiated thyroid cancer (DTC) patients. This study compared the performances of ultrasensitive Tg (ultraTg) and highly sensitive Tg (hsTg) assays in predicting stimulated Tg levels without thyroid-stimulating hormone stimulation.
Methods
Overall, 268 DTC patients who had undergone total thyroidectomy and either radioiodine treatment or I-123 diagnostic scanning were included. Unstimulated and stimulated Tg levels were measured using hsTg (BRAHMS Dynotest Tg-plus) and ultraTg (RIAKEY Tg immunoradiometric assay) assays. Correlations of each assay with the ability of unstimulated Tg levels to predict stimulated Tg ≥1 ng/mL were analyzed.
Results
hsTg and ultraTg showed a strong correlation (R=0.79, P<0.01); the correlation was weaker in Tg antibody-positive patients (R=0.52). UltraTg demonstrated higher sensitivity in predicting stimulated Tg ≥1 ng/mL compared with hsTg. The optimal cut-off for ultraTg was 0.12 ng/mL (sensitivity, 72.0%; specificity, 67.2%). hsTg at 0.105 ng/mL had lower sensitivity (39.8%) but higher specificity (91.5%). Eight discordant cases with low hsTg (<0.2 ng/mL) but elevated ultraTg (>0.23 ng/mL) were identified; three developed structural recurrence within 3.4 to 5.8 years. Two patients had an excellent response according to hsTg but an indeterminate or biochemical incomplete response according to ultraTg.
Conclusion
UltraTg demonstrated higher sensitivity in predicting positive stimulated Tg levels and potential recurrence compared with hsTg. However, its lower specificity may lead to more frequent classifications of biochemical incomplete response. UltraTg may be beneficial in clinically suspicious cases where hsTg falls below the cut-off, but its broader applicability requires further investigation.

Brief Reports

Adrenal gland
Comparative Analysis of Liquid Chromatography-Tandem Mass Spectrometry and Radioimmunoassay in Determining Plasma Aldosterone Concentration and Plasma Renin Activity for Primary Aldosteronism Screening: So Yoon Kwon, Kyeong-Jin Kim, Soo-Youn Lee, Jae Hyeon Kim; Endocrinol Metab. 2024;39(6):965-969. Published online November 15, 2024; DOI: https://doi.org/10.3803/EnM.2024.1985

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Abstract PDF Supplementary Material PubReader ePub: Liquid chromatography-tandem mass spectrometry (LC-MS/MS) accurately measures plasma aldosterone concentration (PAC), but its correlation with radioimmunoassay (RIA), equivalent RIA levels, and optimal cutoff for PAC and aldosterone-to-renin ratio (ARR) in primary aldosteronism (PA) screening have not been determined in a Korean population. Our study of 127 patients who underwent diagnostic testing for PA showed that the LC-MS/MS and RIA methods have good correlation, with a mean bias of 29.3% for PAC. An LC-MS/MS PAC level of 11.7 ng/dL was equivalent to an RIA PAC level of 15 ng/dL. Receiver operating characteristic curve analysis showed that an LC-MS/MS PAC level of 10.3 ng/dL and LC-MS/MS ARR level of 20.0 provided sensitivity of 73.1% with a specificity of 57.3% and sensitivity of 92.3% with a specificity of 14.7%, respectively. When the LC-MS/MS method is used for PA screening, an adjustment of cutoff values is necessary.

Adrenal Gland
Aldosterone Immunoassay-Specific Cutoff Value for Seated Saline Suppression Test for Diagnosing Primary Aldosteronism: So Yoon Kwon, Jiyun Park, So Hee Park, So Hyun Cho, You-Bin Lee, Soo-Youn Lee, Jae Hyeon Kim; Endocrinol Metab. 2022;37(6):938-942. Published online December 6, 2022; DOI: https://doi.org/10.3803/EnM.2022.1535

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Abstract PDF Supplementary Material PubReader ePub

A seated saline loading test (SLT) using liquid chromatography-tandem mass spectrometry (LC-MS/MS) is one of the most accepted confirmatory tests of primary aldosteronism. However, LC-MS/MS is time-consuming and is not widely available in diagnostic laboratories compared to immunoassay. With immunoassay, it is unknown whether SLT in the seated position is more accurate than that of the supine position, and a cutoff value of post-seated SLT plasma aldosterone concentration (PAC) must be established in the Korean population. Ninety-eight patients underwent SLT in both positions, and post-SLT PAC was measured by LC-MS/MS and radioimmunoassay. We confirmed primary aldosteronism if post-seated SLT PAC by LC-MS/MS exceeded 5.8 ng/dL. The area under the receiver operating characteristic curve was greater for seated than supine SLT (0.928 vs. 0.834, P=0.003). The optimal cutoff value of post-seated SLT by radioimmunoassay was 6.6 ng/dL (sensitivity 83.3%, specificity 92.2%).

Citations

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Investigating the cut-off values of captopril challenge test for primary aldosteronism using the novel chemiluminescent enzyme immunoassay method: a retrospective cohort study
Yuta Tezuka, Kei Omata, Yoshikiyo Ono, Kengo Kambara, Hiroki Kamada, Sota Oguro, Yuto Yamazaki, Celso E. Gomez-Sanchez, Akihiro Ito, Hironobu Sasano, Kei Takase, Tetsuhiro Tanaka, Hideki Katagiri, Fumitoshi Satoh
Hypertension Research.2024; 47(5): 1362. CrossRef
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Journal of the Endocrine Society.2024;[Epub] CrossRef
Screening and treatment of endocrine hypertension focusing on adrenal gland disorders: a narrative review
Seung Min Chung
Journal of Yeungnam Medical Science.2024; 41(4): 269. CrossRef
Comparative Analysis of Liquid Chromatography-Tandem Mass Spectrometry and Radioimmunoassay in Determining Plasma Aldosterone Concentration and Plasma Renin Activity for Primary Aldosteronism Screening
So Yoon Kwon, Kyeong-Jin Kim, Soo-Youn Lee, Jae Hyeon Kim
Endocrinology and Metabolism.2024; 39(6): 965. CrossRef

Review Article

Adrenal Gland
Clinical and Technical Aspects in Free Cortisol Measurement: Man Ho Choi; Endocrinol Metab. 2022;37(4):599-607. Published online August 19, 2022; DOI: https://doi.org/10.3803/EnM.2022.1549

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Abstract PDF PubReader ePub

Accurate measurement of cortisol is critical in adrenal insufficiency as it reduces the risk associated with misdiagnosis and supports the optimization of stress dose. Comprehensive assays have been developed to determine the levels of bioactive free cortisol and their clinical and analytical efficacies have been extensively discussed because the level of total cortisol is affected by changes in the structure or circulating levels of corticoid-binding globulin and albumin, which are the main reservoirs of cortisol in the human body. Antibody-based immunoassays are routinely used in clinical laboratories; however, the lack of molecular specificity in cortisol assessment limits their applicability to characterize adrenocortical function. Improved specificity and sensitivity can be achieved by mass spectrometry coupled with chromatographic separation methods, which is a cutting-edge technology to measure individual as well as a panel of steroids in a single analytical run. The purpose of this review is to introduce recent advances in free cortisol measurement from the perspectives of clinical specimens and issues associated with prospective analytical technologies.

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Original Article

Endocrine Research
Comparison of Thyroglobulin Measurements Using Three Different Immunoassay Kits: A BRAMHS Tg-Plus RIA Kit, a BRAMHS hTg Sensitive Kryptor Kit, and a Beckman Coulter ACCESS Immunoassay Kit: Mijin Kim, Min Ji Jeon, Won Gu Kim, Jong Jin Lee, Jin-Sook Ryu, Eun-Jung Cho, Dae-Hyun Ko, Woochang Lee, Sail Chun, Won-Ki Min, Tae Yong Kim, Young Kee Shong, Won Bae Kim; Endocrinol Metab. 2016;31(3):462-468. Published online August 2, 2016; DOI: https://doi.org/10.3803/EnM.2016.31.3.462

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Background

Second-generation thyroglobulin immunometric assays (Tg-IMAs) have been developed with improved sensitivity. Our aim was to compare the diagnostic value of Tg-IMA measurements using a Kryptor (BRAHMS AG) kit (Tg-K) and an ACCESS (Beckman Coulter) kit (Tg-A) with that of the first-generation Tg measurement using a Tg-plus (BRAHMS AG) kit (Tg+).

Methods

We enrolled 82 differentiated thyroid cancer patients who underwent total thyroidectomy with radioactive iodine remnant ablation and who underwent diagnostic whole body scan using recombinant human thyroid stimulating hormone (rhTSH). The Tg+, Tg-K, and Tg-A were measured before rhTSH administration during levothyroxine treatment (suppressed Tg) from the same sample. Serum Tg+ was measured after rhTSH stimulation (stimulated Tg).

Results

Suppressed Tg+ was more significantly correlated with suppressed Tg-K (R²=0.919, P<0.001) than with suppressed Tg-A (R²=0.536, P<0.001). The optimal cut-off values of suppressed Tg+, Tg-K, and Tg-A for predicting stimulated Tg+ of 1 ng/mL were 0.3, 0.2, and 0.2 ng/mL, respectively. The sensitivity, specificity, and accuracy of suppressed Tg+ were 67%, 100%, and 90%, respectively; those of suppressed Tg-K were 83%, 90%, and 88%; those of suppressed Tg-A were 96%, 82%, and 87%, respectively. The positive predictive and negative predictive values of Tg+ were 100% and 87%, respectively; those of Tg-K were 79% and 92%; and those of Tg-A were 73% and 98%.

Conclusion

We could not clearly demonstrate which kit had better diagnostic performance after comparison of first-generation Tg measurements with Tg-IMA measurements. Also, there were kit-to-kit variations between Tg-IMA kits. Suppressed Tg measured by Tg-IMA was insufficient to completely substitute for a stimulated Tg measurement.

Citations

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Comparison of the diagnostic performances of US-guided fine needle aspiration cytology and thyroglobulin measurement for lymph node metastases in patients with differentiated thyroid carcinoma: a meta-analysis
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Preoperative Serum Thyroglobulin and Its Correlation with the Burden and Extent of Differentiated Thyroid Cancer
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