Thyroid hormones and TSH were tested using immunoenzymatic assays (Ortho-clinical diagnostic Inc., Rochester, NY, USA). Reference ranges were 8–18 ng/dL for FT4, 2.5–5.0 ng/L for FT3 and 0.4–4 mIU/L for TSH. Tg was measured by an immunometric assay (Access Thyroglobulin assay; Beckman Coulter, Inc., Fullerton, CA, USA) (functional sensitivity 0.1 ng/mL). TgAbs were measured by AIA-Pack 2000 TgAb-IgGs (Tosoh Corporation, Tokyo, Japan); analytic, functional and positivity cut-offs were 6, 8 and 30 IU/mL, respectively. In this assay, TgAbs interfere with Tg measurement when ≥9.3 IU/mL (16 (link)). TPOAbs were checked by AIA-Pack 2000 TPOAb (Tosoh Corporation) (positivity cutoff >10 IU/mL). TRAbs were tested by ELISA (ElisaRSRTM TRAb 3rd generation, Cardiff, UK) (positivity cutoff > 1.5 IU/mL). Urinary iodine was measured by mass-spectroscopy (reference range 100–300 μg/L). Fasting glucose and glycosylated hemoglobin were measured using standard methods (reference range 60–100 mg/dL for glucose and 20–38 mmol/mol for glycosylated hemoglobin, respectively).
Access thyroglobulin assay
Manufactured by Beckman Coulter
Sourced in United States
The Access Thyroglobulin Assay is a laboratory test used to measure the concentration of thyroglobulin in a patient's blood sample. Thyroglobulin is a protein produced by the thyroid gland and its measurement can provide information about thyroid function.
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Lab products found in correlation
Aia pack 2000 tpoab, by Tosoh (3 mentions)
Architect anti tg, by Abbott (3 mentions)
Aia pack 2000 tgab iggs, by Tosoh (2 mentions)
Dxi 800 analyzer, by Beckman Coulter (1 mentions)
Advia centaur analyzer, by Siemens (1 mentions)
Immulite 2000 xpi analyzer, by Siemens (1 mentions)
Aia pack 2000, by Tosoh (1 mentions)
11 protocols using access thyroglobulin assay
1
Thyroid Hormone and Autoantibody Measurements
2
Thyroglobulin Assay Evolution in RAI Treatment
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All patients included in our study underwent the first RAI treatment until 2015.
The analyses of sTg at ablation and TgAb were performed in the same laboratory and the levels were assessed using the immulite thyroglobulin assay. This is a first-generation Tg assay with a functional sensitivity (FS) of 1.0 ng/ml and a lower limit of detection of 0.2 ng/mL.
For patients who were assessed for response to initial treatment until 2015, sTg was used because, until then, second-generation Tg assays were not available in our laboratory.
After 2015, patients' response to initial treatment was evaluated by measuring the level of suppressed or sTg because, at that time, second-generation Tg assays started to become available in our institution. Hence, thereafter, Tg levels were assessed using the chemiluminescent assay (Access Thyroglobulin Assay; Beckman Coulter) with an FS of 0.1 ng/mL.
The analyses of sTg at ablation and TgAb were performed in the same laboratory and the levels were assessed using the immulite thyroglobulin assay. This is a first-generation Tg assay with a functional sensitivity (FS) of 1.0 ng/ml and a lower limit of detection of 0.2 ng/mL.
For patients who were assessed for response to initial treatment until 2015, sTg was used because, until then, second-generation Tg assays were not available in our laboratory.
After 2015, patients' response to initial treatment was evaluated by measuring the level of suppressed or sTg because, at that time, second-generation Tg assays started to become available in our institution. Hence, thereafter, Tg levels were assessed using the chemiluminescent assay (Access Thyroglobulin Assay; Beckman Coulter) with an FS of 0.1 ng/mL.
3
Thyroglobulin and Anti-Thyroglobulin Assays
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Chemiluminescent assays were used for the measurement of Tg [Access Thyroglobulin Assay, Beckman Coulter, Fullerton, CA (functional sensitivity of 0.1 ng/mL)] and TgAb [Immulite 2000, Diagnostic Products Corporation, Los Angeles, CA (reference value of up to 40 IU/mL) or ARCHITECT Anti-Tg, Abbott Laboratories, IL, USA (reference value of up to 4.11 IU/mL)]. Patients with positive TgAb were excluded.
4
Comprehensive Thyroid Function Assessment
5
Thyroglobulin Assays in Thyroid Cancer
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The analyses of sTg at ablation and TgAb were performed in the same laboratory, and the levels were assessed using the immulite thyroglobulin assay. This is a first-generation Tg assay with a functional sensitivity (FS) of 1.0 ng/mL and a lower limit of detection of 0.2 ng/mL.
For patients assessed for response to initial treatment until 2015, sTg was used because second-generation Tg assays were not available in our laboratory. After 2015, patients' response to initial treatment was evaluated by measuring the sTg levels because as second-generation Tg assays started becoming available in our institution. Thereafter, Tg levels were assessed using the chemiluminescent assay (Access Thyroglobulin Assay; Beckman Coulter) with an FS of 0.1 ng/mL.
TgAb was measured by a chemiluminescent assay (Immulite 2000 [Diagnostic Products Corporation; reference value of up to 40 IU/mL] or ARCHITET TgAb [Abbott Laboratories; reference value of up to 4.11.
For patients assessed for response to initial treatment until 2015, sTg was used because second-generation Tg assays were not available in our laboratory. After 2015, patients' response to initial treatment was evaluated by measuring the sTg levels because as second-generation Tg assays started becoming available in our institution. Thereafter, Tg levels were assessed using the chemiluminescent assay (Access Thyroglobulin Assay; Beckman Coulter) with an FS of 0.1 ng/mL.
TgAb was measured by a chemiluminescent assay (Immulite 2000 [Diagnostic Products Corporation; reference value of up to 40 IU/mL] or ARCHITET TgAb [Abbott Laboratories; reference value of up to 4.11.
6
Thyroid Hormone Measurement Protocols
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Thyroid hormones and TSH were tested using immunoenzymatic assays (Ortho Clinical Diagnostics Inc). Reference ranges were 8 to 18 ng/L for FT4, 2.5 to 5.0 ng/L for FT3, and 0.4 to 4 mIU/L for TSH, respectively. Tg was measured by an immunometric assay (Access Thyroglobulin assay; Beckman Coulter Inc) (functional sensitivity 0.1 ng/mL). TgAbs were measured by an AIA-Pack 2000 TgAb-IgGs (Tosoh Corp); analytic, functional, and positive cutoffs were 6 IU/mL, 8 IU/mL, and 30 IU/mL, respectively. In this assay TgAbs interfere with Tg measurement when greater than or equal to 9.3 IU/mL [6 (link)]. TPOAbs were checked by an AIA-Pack 2000 TPOAb (Tosoh Corp) (positive cutoff > 10 IU/mL). TRAbs were tested by enzyme-linked immunosorbent assay (ElisaRSR TRAb 3rd Generation) (positivity cutoff > 1.5 IU/mL). Urinary iodine was measured by mass spectroscopy (reference range, 100-300 µg/L).
7
Thyroglobulin Assay Variability Assessment
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Tg was measured using a chemiluminescent assay (Access Thyroglobulin Assay, Beckman Coulter, Fullerton, CA). In our laboratory, the interassay imprecision profile assessed within 8 months using 10 different serum pools indicated 26% variability at 0.05 ng/mL, 17% at 0.12 ng/mL, 15% at 0.15 ng/mL, 13% at 0.25 ng/mL, 10% at 0.52 ng/mL, 9% at 0.9 ng/mL, 2.1 ng/mL, 7% at 4.2 ng/mL, and 5% at 7.1 and 10.8 ng/mL (functional sensitivity of 0.1 ng/mL (20% variability)). TgAb were measured using a chemiluminescent assay (IMMULITE 2000, Diagnostic Products Corporation, Los Angeles, CA (reference value of up to 40 IU/mL) or Architect Anti-Tg (Abbott Laboratories, IL; reference value of up to 4.11 IU/mL)).
8
Thyroid Biomarker Measurement Protocol
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Tg was measured by an IMA (Access Thyroglobulin assay; Beckman Coulter, Inc., Fullerton CA) (functional sensitivity 0.1 ng/ml) and TgAbs were assessed by AIA-Pack 2000 (Tosoh Corporation, Tokyo, Japan) (analytic, functional and positive cut-offs: 6, 8 and 30 IU/mL, respectively). The interfering cutoff of this assay, i.e. the threshold for interference with Tg measurement, is 9.3 IU/mL (Latrofa et al. 2016) . Its inter-assay imprecision is <20% through the entire curve. TPOAbs were checked by AIA-Pack 2000 (Tosoh Corporation, Tokyo, Japan) (analytic and positive cut-offs: 3 and 10 IU/mL, respectively). Neck ultrasound was performed by Technos (Esaote Biomedica, Genova, Italy), with a 7.5-MHz linear transducer. After the administration of 131 I activity, whole body scan (WBS) was obtained by a dual-head large field-of-view camera (Philips Axis, Picker International, Inc, Highland Heights, Ohio) with a 6/8-inch-thick crystal equipped with high-energy high-resolution collimators (HEHR).
9
Thyroid Function Measurement Protocols
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Chemiluminescent assays were used for the measurement of Tg (Access Thyroglobulin Assay, Beckman Coulter, Fullerton, CA) and TgAb (Immulite 2000, Diagnostic Products Corporation, Los Angeles, CA, USA) (reference value of up to 40 IU/ml) or ARCHITET Anti-Tg, Abbott Laboratories, IL, USA (reference value of up to 4.11 IU/ml). Patients with TgAb were excluded (Rosario et al. 2004b ). The functional sensitivity obtained with the secondgeneration Tg assay at our laboratory was 0.1 ng/ml (Rosario et al. 2015b ). We used this cut off to define undetectable serum Tg (i.e., %0.1 ng/ml).
10
Thyroid Function Biomarker Assessment
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FT4 and FT3 were measured by free T4 and free T3 reagent packs (Ortho-clinical Diagnostics Inc., Rochester, NY, USA) (reference range 7.0-17.0 pg/mL and 2.7-5.7 pg/mL, respectively). TSH was determined using Immulite 2000 (Euro/DPC, Gwynedd, UK) (reference range 0.4-3.6 μU/mL). Tg was measured by an IMA (Access Thyroglobulin assay; Beckman Coulter, Inc., Fullerton CA) (functional sensitivity 0.1 ng/mL). TgAb were measured using AIA-Pack 2000 TgAb (functional sensitivity 8 IU/mL), positive cut-off 30 IU/mL) and TPOAb using AIA-Pack 2000 TPOAb (analytical sensitivity 3 IU/mL, positive cutoff 10 IU/mL), both by Tosoh Corporation, Tokyo, Japan. TRAb were measured using the Brahms TRAk human RIA assay (Hennigsdorf, Germany) (analytical sensitivity 1 IU/mL, cutoff 1.5 IU/mL).
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