Amgen, Inc. v. F. Hoffmann-La Roche Ltd., Roche Diagnostics GmbH, and Hoffmann-La Roche Inc. (No. 05-12237-WGY)

AbstractDysthyronemia is the state of the thyroid gland in which the concentration of thyrotropin (TSH) in circulation is within the reference range, but the concentrations of free or total fractions of thyroid hormones (TH) are outside the reference range. Normal values of TSH and increased values of TH are referred to as hyperthyroxinemia or hypertriiodothyroninemia, while normal values of TSH and decreased values of TH are called hypothyroxinemia or hypotriiodothyroninemia.Thyroid diagnostic tests were carried out at the Institute of Endocrinology, Prague, Czech Republic, in 1999–2009 using the immunoanalytical systems of Roche Diagnostics GmbH, Germany (Elecsys 2010, Modular E170).Hyperthyroxinemia was found in 6.74% of all parallel sets of TSH and free thyroxine (FT4, n=259,590) values. Hypotriiodothyroninemia was observed in 8.48% of all parallel sets of TSH and total triiodothyronine (TT3, n=73,143). The occurrence of hyperthyroxinemia (TSH-FT4) and hypotriiodothyroninemia (TSH-TT3) was >3 times higher than the occurrence of dysthyronemia for the combinations TSH-FT4 (hypothyroxinemia), TSH-TT4 (total thyroxine, n=1996), TSH-FT3 (free triiodothyronine, n=94,090), and TSH-TT3 (hypertrijodthyroninemia), and >5 times higher in comparison with the combinations TSH-FT4-FT3 (n=93,683), TSH-FT4-TT3 (n=72,373), TSH-FT3-TT3 (n=2466), TSH-TT4-TT3 (n=1779), TSH-FT4-TT4 (n=1571), and TSH-FT3-TT4 (n=1466).In light of our patient types, we are assuming that the observed hypotriiodothyroninemia (TSH-TT3, 8.48%) is due to a decreased concentration of thyroid binding globulin in postmenopausal women and that hyperthyroxinemia (TSH-FT4, 6.74%) is caused mainly by endogenous autoantibodies against thyroxine in patients with thyroid autoimmune diseases.

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Controlling der Qualität von Kundenstammdaten bei der Roche Diagnostics GmbH

Controlling & Management ◽

10.1007/s12176-009-0011-5 ◽

2009 ◽

Vol 53 (1) ◽

pp. 30-33 ◽

Cited By ~ 1

Author(s):

Jan Philipp Rohweder

Keyword(s):

Roche Diagnostics Gmbh ◽

Roche Diagnostics

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Plasma free DNA

Biochemia Medica ◽

10.11613/bm.2019.010904 ◽

2018 ◽

Vol 29 (1) ◽

pp. 153-156 ◽

Cited By ~ 6

Author(s):

Dietmar Enko ◽

Gabriele Halwachs-Baumann ◽

Gernot Kriegshäuser

Keyword(s):

Blood Collection ◽

Plasma Samples ◽

Cell Free Dna ◽

Free Dna ◽

Roche Diagnostics Gmbh ◽

Dna Collection ◽

Roche Diagnostics ◽

The Impact ◽

Time Point ◽

Circulating Cell Free Dna

Introduction: Standardized pre-analytical blood sample procedures for the analysis of circulating cell-free DNA (ccfDNA) are still not available. Therefore, the present study aimed at evaluating the impact of storage conditions related to different times (24 and 48 h) and temperatures (room temperature (RT) and 4 - 8 °C) on the plasma ccfDNA concentration of blood samples drawn into Cell-Free DNA collection tubes (Roche Diagnostics GmbH, Mannheim, Germany). Materials and methods: Venous blood from 30 healthy individuals was collected into five 8.5 mL Cell-Free DNA Collection Tubes (Roche Diagnostics GmbH) each. Plasma samples were processed at time point of blood collection (tube 1), and after storage under the following conditions: 24 h at RT (tube 2) or 4-8 °C (tube 3), and 48 h at RT (tube 4) or 4 - 8 °C (tube 5). Circulating cell-free DNA concentrations were determined by EvaGreen chemistry-based droplet digital PCR (ddPCR). Results: No statistically significant differences between median (interquartile range) plasma ccfDNA concentrations (ng/mL) at time point of blood collection (3.17 (2.13 – 3.76)) and after storage for 24 h (RT: 3.02 (2.41 – 3.68); 4-8 °C: 3.21 (2.19 – 3.46)) and 48 h (RT: 3.13 (2.10 – 3.76); 4-8 °C: 3.09 (2.19 – 3.50)) were observed (P values from 0.102 – 0.975). Conclusions: No unwanted release of genomic DNA from white blood cells could be detected in plasma samples after tube storage for 24 and 48 h regardless of storage temperature.

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Langzeitglykämie und Hypoglykämien nach Teilnahme am strukturierten Behandlungs- und Schulungsprogramm „Insulinpumpen-Therapie für erwachsene Patienten mit Diabetes mellitus Typ 1” von Roche Diagnostics GmbH

Diabetologie und Stoffwechsel ◽

10.1055/s-2007-960656 ◽

2007 ◽

Vol 2 (3) ◽

pp. 161-168 ◽

Cited By ~ 2

Author(s):

U. Müller ◽

W. Hunger-Dathe ◽

N. Müller ◽

V. Lodwig ◽

L. Langen ◽

...

Keyword(s):

Diabetes Mellitus ◽

Diabetes Mellitus Typ 1 ◽

Roche Diagnostics Gmbh ◽

Roche Diagnostics

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