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The Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in vitro test for the quantitative determination of lipoprotein (a) [Lp(a]] in human serum and plasma on cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests.

The Tina-quant Lipoprotein (a) Gen.2 Molarity assay is an in vitro test for the quantitative determination of lipoprotein (a) [Lp(a)] in human serum and plasma on cobas c systems. The measurement of Lp(a) is useful in evaluating lipid metabolism disorders and assessing atherosclerotic cardiovascular disease risk, when used in conjunction with clinical evaluation and other lipoprotein tests. Tina-quant Lipoprotein (a) Gen.2 Molarity assay quantifies lipoprotein (a) in human serum and plasma and reports the values in nmoVL with calibrator values traceable to the WHO/IFCC SRM2B reference material. Reagents - working solutions R1: Glycine buffer: 170 mmol/L. pH 7.0: stabilizers: BSA: rabbit serum 0.1 %, preservative R3: Latex particles coated with polyclonal anti-human lipoprotein (a) antibodies (rabbit): 0.5 %; glycine buffer: 170 mmol/L, pH 7.3, BSA; preservative

ONLINE TDM Methotrexate is an in vitro test for the quantitative determination of methotrexate in human serum and plasma on cobas c systems. The determination of methotrexate is used for monitoring levels of methotrexate to ensure appropriate therapy.

The ONLINE TDM Methotrexate assay is an in vitro test for the quantitative determination of methotrexate in human serum and plasma on cobas c systems. The determination of methotrexate is used for monitoring levels of methotrexate to ensure appropriate therapy. The ONLINE TDM MTX assay is a two-reagent system used for the detection of methotrexate in serum and plasma. In this technology drug hapten attached to the enzyme glucose 6 phosphate dehydrogenase (G6PDH) serves as the binding partner to anti-methotrexate antibody. A competitive reaction to a limited amount of specific anti-methotrexate antibody takes place between the enzyme bound hapten and free methotrexate in the sample. Enzyme activity is reduced with bound antibody. Only active enzymes reduce NAD+ to NADH. The rate of NADH formation during the reaction correlates to the methotrexate concentration and is measured photometrically. The ONLINE TDM MTX assay is a homogeneous enzyme-immunoassay. Reagents - working solutions R1: Anti-methotrexate antibody (rabbit monoclonal), 3 µg/mL; NAD, G6P, bovine serum albumin in water, pH 6.3; preservative R3: Methotrexate hapten conjugated to G6PDH, 0.3 µg/mL; bovine serum albumin in buffer, pH 7.8; preservative

The Tina-quant Hemoglobin A1cDx Gen.3 assay is intended for use as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. It is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or venous whole blood on the cobas c 503 clinical chemistry analyzer. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Tina-quant Hemoglobin A1cDx Gen.3 assay is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on the cobas c 503 clinical chemistry analyzer. The assay offers separate applications that are specific to the sample types whole blood and hemolysate. The Whole Blood Application differs from the Hemolysate Application in the hemolyzing step. For the Whole Blood Application, whole blood samples are placed on the analyzer and hemolysis occurs onboard the analyzer. For the Hemolysate Application, hemolyzed samples are placed on the analyzer and hemolysis occurs manually before placing the samples onboard the analyzer. The two applications yield the same results. Hemolyzing reagent is part of the test system and is either placed on board the analyzer for the Whole Blood Application or used manually for the Hemolysate Application. Anticoagulated whole blood is hemolyzed either manually or automatically prior to determination of HbAlc by a turbidimetric inhibition immunoassay. Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbAlc from the HbAlc/Hb ratio according to a user selected protocol, either IFCC or NGSP protocols.

Tina-quant® C-Reactive Protein IV is an immunoturbidimetric assay for the in vitro quantitative determination of CRP in human serum and plasma on cobas c systems. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and plasma. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

The Tina-quant® C-Reactive Protein IV reagent will be a liquid ready to use 2 component particle enhanced immunoturbidimetric assay. Reagents - working solutions R1: TRIS* buffer with bovine serum albumin; preservatives R2 Latex particles coated with anti-CRP (mouse) in glycine buffer; immunoglobulins (mouse); preservative * TRIS= Tris(hydroxymethyl)-aminomethane The Tina-quant® C-Reactive Protein IV assay will be based on the DUREL technology (dual radius enhanced latex - technology) which is also used in C-Reactive Protein Gen.3 predicate method. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The aggregates are determined turbidimetrically.

The Ammonia II assay is an enzymatic in vitro test for the quantitative determination of ammonia in human plasma on Roche/Hitachi cobas c systems. Ammonia measurements are used in the diagnosis and treatment of severe liver disorders, such as cirrhosis, hepatitis, and Reye's syndrome.

The Ammonia II (NH3L2) assay is an enzymatic in vitro test for the quantitative determination of ammonia in human plasma on Roche/Hitachi cobas c systems. The Ammonia II assay is an enzymatic method, with glutamate dehydrogenase.

Tina-quant Transferrin ver.2 (urine application) assay is an in vitro test for the quantitative determination of transferrin in human urine on Roche/Hitachi cobas c systems. A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in urine. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.

The Tina-quant Transferrin ver.2 (urine application) assay is a two reagent assay for the in vitro quantitative determination of transferrin in human urine on automated clinical chemistry analyzers. It is an immunoturbidimetric assay in which human transferrin forms a precipitate with a specific antiserum which is determined turbidimetrically. Engineering drawings, schematics, and figures are not pertinent to describe the device, as the device is a reagent.

cobas b 101 system: The cobas b 101 instrument is a multi-assay system designed to quantitatively analyze cobas reagent discs. The system is intended for professional, in vitro diagnostic use in a clinical laboratory setting or point-of-care (PoC) locations. HbA1c test: The cobas HbA1c Test is an in vitro diagnostic test designed to quantitatively determine glycated hemoglobin (HbA1c) in human capillary and venous whole blood on the cobas b 101 instrument. The system is intended for professional use in a clinical laboratory setting or point-of-care (PoC) locations. Measurement of hemoglobin A1c is used to assess the level of control of a patient's diabetes and to monitor long term blood glucose control. Elevated levels of hemoglobin A1c indicate uncontrolled diabetes in a patient.

The cobas b 101 system is a bench top analyzer which measures HbA1c. The system is fully automated, self-contained and utilizes a single use reagent disc. The system has the ability to measure capillary or venous whole blood samples. Sample is applied directly from the fingerstick or via a pipette when testing venous whole blood. The operator simply applies sample to the disc and places the disc in the instrument. There are no pre-analytics needed as the disc is self-filling by capillary forces. There is no intervention by the operator during measurement. At completion of the test, the instrument displays a quantitative result. No calculations or interpretation are required by the operator. Calibration of the instrument is completed as part of the manufacturing process. Calibration information is contained on each disc and is read when the disc is loaded on the instrument. No calibration intervention is required by the operator. An optional barcode scanner can be provided to read barcode information for patient identification. The barcode scanner uses LED as the light source. Results can be printed out by using an optional external printer. A connection to a Data Management System is possible either via a USB interface to a local PC or via an Ethernet converted to a Laboratory Information Management System (LIMS). The communication protocol is defined according to the CLSI approved POCT1-A2 standard. HbA1c (glycated hemoglobin) can be determined by using samples from capillary blood directly from the fingertip or from venous whole blood with heparin or EDTA (K2 or K3) anticoagulant. The blood sample is diluted and mixed with TRIS buffer to release hemoglobin from the erythrocytes. A fraction of the sample is conveyed into a reaction chamber where it is mixed with sodium lauryl sulfate (SLS). SLS is used to form the SLS-hemoglobin complex. The concentration of total hemoglobin is calculated by measuring SLS-hemoglobin complex with a wavelength of 525 nm. Hemoglobin A1c (HbA1c) in another fraction of the sample is first denaturated by potassium ferricyanide and sucrose laurate. The denatured HbA1c bonds with HbA1c antibody on the latex particle. Latex agglutination inhibition reaction then occurs by reacting the agglutinator that has synthetic antigen which can bond with HbA1c antibody. The concentration of HbA1c is calculated by measuring the latex agglutination inhibition reaction with a wavelength of 625 nm. The % hemoglobin A1c value is measured using a ratio of concentrations of HbA1c to total hemoglobin.

ALP IFCC Gen.2 is an in vitro test intended for the quantitative determination of the catalytic activity of alkaline phosphatase in human serum and plasma on COBAS INTEGRA systems. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

The Roche ALP IFCC Gen.2 assay provides quantitative measurement of the catalytic activity of alkaline phosphatase in human serum and plasma in accordance with a standardized method.. The reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 (position B) and SR (position C). In the presence of magnesium and zinc ions, p-nitrophenyl phosphate is cleaved by phosphatases into phosphate and p-nitrophenol. The p-nitrophenol released is directly proportional to the catalytic ALP activity. It is determined by measuring the increase in absorbance.

The cobas c 513 clinical chemistry analyzer is a fully automated, standalone clinical chemistry analyzer intended for the in-vitro quantitative determination of analytes in body fluids. The Tina-quant Hemoglobin A1cDx Gen.3 assay is intended for use as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes. It is an in vitro diagnostics reagent system intended for quantitative determination of mmol/mol hemoglobin A1c (IFCC) and % hemoglobin A1c (DCCT/NGSP) in hemolysate or whole blood on the Roche/Hitachi cobas c 513 clinical chemistry analyzer. HbA1c determinations are useful for monitoring of long-term blood glucose control in individuals with diabetes mellitus.

The cobas c 513 clinical chemistry analyzer is a fully automated, software controlled analyzer system for in vitro quantitative determination of analytes in human body fluids. The cobas c 513 analyzer system includes a control unit and an analyzer with a closed tube sampling functionality. The cobas c 513 control unit includes a computer (PC) located in the sampler unit, a touchscreen monitor, soft-keyboard, a mouse (optional use), and a printer. The control unit is used to perform tasks on the analyzer and the PC runs the software that controls the analyzer. The software manages all instrument functions, all system functions, and all information related to orders and results. The software offers a graphical user interface (GUI) to control all functions by the operator. The control unit contains System Control software including interfaces to a Medical Device Data System (cobas Link) and to the customer Laboratory Information System (LIS). The analyzer is composed of the sampler unit and the analytical unit. The sampler unit is composed of the rack loading/unloading areas, a barcode reader, a rack rotor, a STAT port, and conveyor lines. It is used to load and unload racks, power on the system, access the PC, and manage the conveyance of samples to the analytical unit. The analytical unit is comprised of the reagent area, the sample area, and the reaction disk. Samples are conveyed to the analytical unit from the sample unit for photometric analysis before being returned to the sample unit. Anticoagulated whole blood is hemolyzed either manually or automatically prior to determination of HbAlc by a turbidimetric inhibition immunoassay. Liberated hemoglobin (Hb) in the hemolyzed sample is converted to a derivative having a characteristic absorption spectrum and measured bichromatically. The instrument calculates the % HbAlc from the HbAlc/Hb ratio according to a user selected protocol, either IFCC or NGSP protocols. The assay offers separate applications that are specific to the sample types whole blood and hemolysate. The Whole Blood Application differs from the Hemolysate Application in the hemolyzing step. For the Whole Blood Application, whole blood samples are placed on the analyzer. Hemolysis occurs onboard the analyzer. For the Hemolysate Application, hemolyzed samples are placed on the analyzer. Hemolysis occurs manually before placing the samples onboard the analyzer. The two applications yield the same results.

In vitro diagnostic test for the quantitative determination of the HDL-cholesterol concentration in human serum and plasma on Roche/Hitachi cobas c systems. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

The HDL-Cholesterol Gen.4 is a homogeneous enzymatic colorimetric test. Non-HDL lipoproteins such as LDL, VLDL and chylomicrons are combined with polyanions and a detergent forming a water-soluble complex. In this complex the enzymatic reaction of CHER and CHOD towards non-HDL lipoproteins is blocked. Finally only HDL-particles can react with CHER and CHOD. The concentration of HDL-cholesterol is determined enzymatically by CHER and CHOD.