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Cobas 601 analyzer

Manufactured by Roche
Sourced in Switzerland

The Cobas 601 analyzer is a laboratory instrument designed for automated clinical chemistry and immunochemistry testing. It performs a variety of diagnostic tests on biological samples, providing healthcare professionals with reliable and accurate results to support patient care. The Cobas 601 is a core component of the Roche Diagnostics' comprehensive portfolio of laboratory solutions.

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12 protocols using cobas 601 analyzer

1

Comprehensive Thyroid Function Assessment

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Total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TGs) and low-density lipoprotein cholesterol (LDL-C) were measured with an automatic biochemical analyzer (Mindray BS-180 Analyzer). Bio-Rad reagents were used for HbA1c measurement. We used the hexokinase enzymatic method to measure fasting blood glucose. Serum thyroid-stimulating hormone (TSH) and free thyroxine (FT4) values were measured with an electrochemiluminescence immunoassay on a Cobas 601 analyzer (Roche Diagnostics, Switzerland). Serum TSH, thyroid peroxidase antibodies (TPOAbs) and thyroglobulin antibodies (TGAbs) were measured with an electrochemiluminescence immunoassay on a Cobas 601 analyzer (Roche Diagnostics, Switzerland). When the TSH level exceeded the upper limit of the reference range (0.27-4.20 mIU/L), FT4 and free triiodothyronine (FT3) levels were measured. UIC was measured by inductively coupled plasma−mass spectrometry (Agilent 7700x; Agilent Technologies, Santa Clara, CA). All participants underwent thyroid ultrasonography by specially trained technicians using a portable instrument (LOGIQ 100 PRO; GE, Milwaukee, WI, with 7.5-MHz linear transducers). Two trained quality control personnel apart from the sonographers were responsible for supervising the accuracy and reliability of the ultrasound results.
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2

Comprehensive Biomarker Assessment in Fasting Samples

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Whole blood samples were drawn after overnight fasting. The urinary iodine concentration (UIC) was measured using inductively coupled plasma mass spectrometry (Agilent 7700×, Agilent Technologies, USA). The fasting blood glucose (FBG) level was measured using glucose-oxidase assay method. The glycosylated hemoglobin (HbA1c) levels were measured using high-performance liquid chromatography (BioRad VARIANT II Haemoglobin Analyzer). The cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), triglyceride (TG), and blood uric acid (UA) levels were measured using enzyme-based assays (Mindray BS-180 Analyzer). The anti-thyroglobulin antibodies (TgAb), TSH concentration, and thyroid peroxidase antibodies (TPOAbs) were detected and measured using immunochemiluminescence assays (Cobas 601 analyzer, Roche Diagnostics).
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3

Thyroid Function Biomarker Evaluation

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Serum levels of TSH, FT3, FT4, TgAb, and TPOAb were measured using automated chemiluminescent immunoassays (Architect i2000SR; Abbott Laboratories, Chicago, IL). The functional sensitivity of serum TSH was 0.0036 mIU/L. The intra-assay coefficients of variation (CV) of serum TSH, FT4, FT3, TPOAb, and TgAb were 1.3–6.3% and the interassay CV values were 2.0%–6.6%. The laboratory reference ranges provided by the manufacturer used in this study were as follows: TSH 0.35–4.94 μIU/mL, FT4 9.01–19.04 pmol/L, FT3 2.63–5.70 pmol/L, TPOAb < 5.61 IU/ml, and TgAb < 4.11 IU/mL. Serum levels of TRAb were measured by electrochemiluminescence immunoassays (Cobas 601 analyzer, Roche Diagnostics) with a suggested cut-off value of 1.75 IU/L. The functional sensitivity of serum TRAb was 0.3 IU/L. The laboratory reference range for ESR was <20 and <15 mm/h for women and men, respectively. Clinical data on RAI uptake were obtained at the nuclear medicine department of Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine. The reference range for RAI uptake was 10–30% for 3-hour uptake and 45–60% for 24-hour uptake.
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4

Thyroid Function Biomarker Assessment

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The serum levels of TSH, FT3, FT4, TgAb, and TPOAb were tested by automated chemiluminescent immunoassays (Architect i2000SR; Abbott Laboratories, Chicago, IL). The functional sensitivity of serum TSH was 0.0036 mIU/L. The laboratory reference ranges provided by the manufacturer are as follows: TSH, 0.35–4.94 mIU/L; FT4, 9.01–19.05 pmol/L; FT3, 2.63–5.70 pmol/L; TPOAb, < 5.61 IU/mL; and TgAb, < 4.11 IU/mL. The serum levels of TRAb were measured by electrochemiluminescence immunoassays (Cobas 601 analyzer, Roche Diagnostics) with a suggested cut-off value of 1.75 IU/L
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5

Hormonal Assessment for Ovulation Induction

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Hormone levels were determined in venous blood by the electrochemical method with a cobas 601 analyzer (Roche, Switzerland) in our hospital laboratory. Before beginning an ovulation-stimulating protocol, basal levels of the following hormones were determined in blood taken on day 2 or 3 of the menstrual cycle (follicular phase: reference ranges): E2 (12.4–233.0 pg/mL), FSH (3.5–12.5 IU/L), LH (2.4–12.6 IU/L), prolactin (PRL; 4.79–23.3 ng/mL), testosterone (T; 0–0.8 ng/mL), and progesterone (P; 0.2–1.5 ng/mL). FSH, LH, and E2 levels were re-assessed immediately before starting the Gn phase. LH and P levels were re-assessed immediately before hCG administration (Fig. 1).
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6

Thyroid Hormones and Metabolic Markers Assessment

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Venous blood samples were collected between 8:00 a.m. and 10:00 a.m. after fasting overnight. Serum stored at −20°C was tested for thyroid hormones, including thyroid-stimulating hormone (TSH), free thyroxine (fT4), and free triiodothyronine (fT3) which were quantified using the immunochemiluminometric assay (ICMA) method on a Cobas 601 analyzer (Roche Diagnostic, Switzerland), using the standard kits from Roche Diagnostics GmbH (Germany). To screen the prevalence of thyroid disorders in the population, fT4 and fT3 were measured only among those with abnormal levels of TSH. The fT3, fT4, and TSH had a reference range of 3.1–6.8 pmol/L, 12–22 pmol/L, and 0.27–4.2 mIU/L, respectively. Midstream urine samples were collected in the morning and stored at −20°C. Urinary iodine concentration (UIC) was quantified using the ammonium persulfate method. Serum total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), and fasting plasma glucose levels were measured by an automated procedure (BS180; Mindray, Ltd., Shenzhen, China) immediately. Hemoglobin (Hb) A1c was measured by High-Performance Liquid Chromatography (HPLC) using an automated analyzer (VARIANT™ II TURBO, BioRad, Berkeley, USA) immediately.
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7

Thyroid Parameter Measurement Protocol

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Venous blood samples were collected from each participant and transported via a cold chain system to the Central Laboratory in Shenyang for unified testing of thyroid parameters. Serum TSH, thyroid peroxidase antibody (TPOAb), and thyroglobulin antibody (TgAb) levels were measured using an electrochemiluminescence immunoassay on a Cobas 601 analyzer (Roche Diagnostics, Basel, Switzerland) at the Central Laboratory in Shenyang. The sensitivity and specificity of the TSH assay was 0.01 μIU/mL. FT3 and FT4 levels were measured only if TSH levels were outside the reference range (0.27–4.20 mIU/L). The normal ranges for TPOAb, TgAb, and TSH provided by the manufacturers were < 34.00 IU/mL, < 115.00 IU/mL, and 0.27–4.20 mIU/L, respectively. Urine iodine concentration (UIC) was determined using inductively coupled plasma mass spectrometry (Agilent 7700x; Agilent Technologies Inc., Santa Clara, CA, USA). The measurement quality was controlled using certified reference material (GBW09108, GBW9109, and GBW9110) from the Center for Disease Control in China. The target values of the standards GBW09108, GBW9109, and GBW9110 were 70.8 ± 9.0, 143 ± 10, and 224 ± 14 μg/L, respectively; the inter-assay coefficients of variability were 2.3%, 2.5%, and 2.4%, respectively; and the intra-assay coefficients of variability were 2.7%, 1.4%, and 2.3%, respectively.
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8

Serum TSH and FT4 Measurement

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Fasting blood samples were taken from each individual. After centrifugation, the serum was stored at −20°C and sent through a cold chain logistics system to the central laboratory in Shenyang for unified testing. Serum TSH was detected by a Cobas 601 Analyzer (Roche Diagnostics, Rotkreuz, Switzerland). Free thyroxine (FT4) was measured as TSH above the upper limit of the reference range (ULRR).
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9

Comprehensive Thyroid and Metabolic Assessment

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After the survey was completed, all specimens collected were airlifted through a cold chain system to the institute of Endocrinology of China Medical University for centralized tests. Blood glucose (BG) was tested by the Hexokinase method (Au400 automatic analyzer, Olympus, Japan). Serum triglycerides (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) were determined by Mindray's kit and biochemical detector (BS-180, Mindray, Shenzhen, China). The glycated hemoglobin (HbA1c) assay was measured by Bio Rad reagents. Serum TSH, TPOAb, and TgAb levels were determined by the electrochemical luminescence immunoassay using the Cobas 601 analyzer (Roche Diagnostic, Switzerland). Urine iodine concentration (UIC) was examined using an inductively coupled plasma mass spectrometry (ICP-MS) (Agilent 7700x, Agilent Technologies, USA).
All participants underwent thyroid ultrasonography by qualified medical staffs using a portable instrument (LOGIQ 100 PRO, GE, Milwaukee, WI, USA with 7.5 MHz linear transducers).
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10

Measurement of Metabolic Biomarkers in Fasting Blood Samples

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After fasting for 8 hours at night, the venous blood samples were collected in the morning. The fasting plasma glucose (FPG), total cholesterol (TC), triglyceride (TG), high-density lipoprotein cholesterol (HDL-C), and low-density lipoprotein cholesterol (LDL-C) levels were measured using the Bs-220Automatic Biochemical Analyzer (Mairui Biotechnology Co. Ltd, China). The reagent was purchased from Meigao Medical Technology Co. Ltd (China).
The serum TSH levels of every subject were measured by chemiluminescence immunoassay (Cobas 601 Analyzer, Roche diagnostics, Switzerland). The reference range of serum TSH was 0.27-4.20 mIU/l, and the limit of detection was 0.002 mIU/l. The intra-assay and inter-assay coefficient of variation were 1.9-9.5 % and 1.1-6.3 %, respectively. The urinary iodine concentration was determined by inductively coupled plasma mass spectrometry (Agilent 7700x, Agilent Technologies, USA). The intra-assay coefficients of variation were 2.3, 2.5 and 2.4 %, and inter-assay coefficients of variation were 2.7, 1.4 and 2.3 %, respectively.
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