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CardioPhase hsCRP is an in-vitro diagnostic reagent for the quantitative determination of C-reactive protein (CRP) in human serum, and heparin and EDTA plasma by means of particle enhanced immunonephelometry using the BN II and BN ProSpec® System. In acute phase response, increased levels of a number of plasma proteins, including C-reactive protein, is observed. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. High sensitivity CRP (hsCRP) measurements may be used as an independent risk marker for the identification of individuals at risk for future cardiovascular disease. Measurements of hsCRP, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

The CardioPhase hsCRP assay is an in-vitro diagnostic reagent for the quantitative determination of Creactive protein (CRP) in human serum, and heparinized and EDTA plasma by means of particleenhanced immunoassay determination. The assay is traceable to the international standard ERM-DA474/IFCC. N Rheumatology Standard SL (cleared under K964527) is used for the establishment of reference curves for the immunonephelometric determination of C-reactive protein on the BN II and BN ProSpec® Systems. This calibrator consists of a mixture of human sera and elevated concentrations of CRP. The CardioPhase hsCRP reagent is a suspension of polystyrene (Latex) particles to which mouse monoclonal anti-human CRP antibodies (< 0.016 g/L) have been attached by covalent bonding. The reagent is a ready-to-use liquid containing preservatives. There are two product variants available. One variant (REF OQIY13) contains 3 x 2 mL vials / box, and the other variant (REF OQIY21) contains 5 x 5 mL vials / box. The assay's polystyrene particles coated with monoclonal antibodies specific to human CRP are aggregated when mixed with samples containing CRP. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the relevant protein in the sample. The result is evaluated by comparison with a standard of known concentration.

The C-Reactive Protein Extended Range (RCRP) method used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended for the quantitative determination of CRP in human serum and plasma (lithium heparin). Measurement of C-Reactive Protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.

The RCRP method is based on a particle enhanced turbidimetric immunoassay (PETIA) technique. Synthetic particles coated with antibody to C-Reactive Protein (AbPR) aggregate in the presence of C-Reactive Protein in the sample. The increase in turbidity which accompanies aggregation is proportional to the C-Reactive Protein concentration.

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 Optilite High Sensitivity C-Reactive Protein Kit is intended for the quantitative in vitro measurement of C-Reactive Protein in serum using the Binding Site Optilite analyser for evaluation of conditions thought to be associated with inflammation, in otherwise healthy individuals. This test should be used in conjunction with other laboratory and clinical findings.

The Optilite High Sensitivity C-Reactive Protein Kit is comprised of latex reagent, single calibrator, controls (high and low) and reaction buffer in liquid form. The reagents contain 0.099% sodium azide as preservative.

The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injurv to body tissues and for evaluation of infection, tissue injurv, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

The Optilite C-Reactive Protein Reagent is comprised of a dual wedge containing the following: Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0. Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives. The Optilite C-Reactive Protein Calibrator is comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative. The Optilite C-Reactive Protein Controls are comprised of the following: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative.

The MSD CRP Kit is intended for in vitro diagnostic use in the quantitative determination of C-reactive protein (CRP) in human serum using the MESO SECTOR S 700 instrument. Measurement of CRP aids in the evaluation of infection, tissue injury, and inflammatory disorders. This test will be performed in a hospital or clinical laboratory setting by trained laboratory personnel. The target patient population for the MSD CRP Assay is symptomatic adults. Clinicians should utilize the results of the MSD CRP Assay for diagnosis of inflammatory diseases in conjunction with other clinical and laboratory findings. The SECTOR S 700 instrument is intended for the in-vitro determination of analytes in bodily fluids. This instrument is not intended for Point-of-Care use.

The MSD CRP Assay Kit is a quantitative in-vitro diagnostic assay for conventional measurement of C-reactive protein in human serum. The CRP Assay Kit is designed for use with the MESO SECTOR® S 700 Instrument. The kit components include the 96-well CRP assay plate, CRP calibrator, CRP detection antibody, CRP diluent and CRP read buffer. The assay in the MSD CRP Kit is a sandwich immunoassay employing electrochemiluminescence (ECL) detection. In the instrument, a voltage is applied to the plate electrodes causing the captured labels to emit light. The instrument measures the intensity of emitted light from each spot to provide a quantitative measure of analyte in the sample.

The C-Reactive Protein Kit for use on SPAPLUS is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This product is suitable for use on the SPAPLUS analyser.

The C-Reactive Protein Kit for use on SPAPLUS is comprised of the following reagents: Antiserum: Supplied in stabilised liquid form. Preservatives: 0.099% sodium azide, TRIS pH 8.0. Calibrator and Controls: Pooled human serum, supplied in stabilised liquid form. Containing 0.099% sodium azide, as preservative. The concentration given on the quality control certificate has been obtained by comparison with the international reference standard ERM-DA474. Reaction Buffer: Containing 0.099% sodium azide, TRIS pH 7.5 as preservatives.

The Hitachi Clinical Analyzer S TEST reagent cartridge CRP is intended for the quantitative measurement of C-reactive protein in serum, lithium heparin plasma, K3 EDTA plasma, and sodium citrate plasma. The test system is intended for use in clinical laboratories or physician office laboratories. CRP measurements aid in the evaluation of injury to body tissues, and infection and inflammatory disorders. For in vitro diagnostic use only.

The Hitachi Clinical Analyzer is an automatic, bench-top, wet chemistry system intended for use in clinical laboratories or physician office laboratories. The instrument consists of a desktop analyzer unit, an operations screen that prompts the user for operation input and displays data, a printer, and a unit cover. The analyzer unit includes a single probe, an incubation rotor, carousels for sample cups and reagent cartridges, and a multi-wavelength photometer. The single-use reagent cartridges may be placed in any configuration on the carousel, allowing the user to develop any test panel where the reagent cartridges are available. The S TEST reagent cartridges are made of plastic and include two small reservoirs capable of holding two separate reagents (R1 and R2), separated by a reaction cell/photometric cuvette. The cartridges also include a dot code label that contains all chemistry parameters, calibration factors, and other production-related information, e.g., expiration dating. The dimensions of the reagent cartridges are: 13.5 mm (W) x 28 mm (D) x 20.2 mm (H). System operation: After the sample cup is placed into the carousel, the analyzer pipettes the sample, pipettes the reagent, and mixes (stirs) the sample and reagent together. After the sample and reagent react in the incubator bath, the analyzer measures the absorbance of the sample, and based on the absorbance of the reactions, it calculates the concentration of analyte in the sample. The test system can measure analytes in serum or plasma and results are available in approximately 15 minutes per test. This submission is for reagent cartridge test systems for CRP. Chemistry reactions: CRP in samples causes an antigen-antibody reaction with latex sensitizes with Goat antihuman C-Reactive Protein antibody to induce agglutination. The concentration of CRP can be determined by measuring this agglutination as the amount of change in absorbance. CRP + Goat anti-human C-reactive protein antibody coated latex -> Agglutination due to antigen-antibody reaction

The Piccolo® C-Reactive Protein Test System used with the Piccolo xpress™ Chemistry Analyzer is intended to be used for the in vitro quantitative determination of CRP concentration in lithium heparinized whole blood, lithium heparinized plasma, or serum in a clinical laboratory setting or point of care location. This test is not intended for high sensitivity CRP measurement. C-Reactive Protein test results aid in the evaluation of infection, tissue injury, and inflammatory disorders in conjunction with other laboratory and clinical findings.

The Piccolo MetLyte Plus CRP Reagent Disc (which contains the Piccolo C-Reactive Protein Test System) is designed for lithium heparinized whole blood, lithium heparinized plasma, and serum, only. The disc meters the required quantity of sample and diluent, mixes the sample with diluent, and delivers the mixture to the reaction cuvettes along the disc perimeter. The diluted sample mixes with the reagent beads, initiating the chemical reactions that are then monitored by the analyzer.

Immunoturbidometric assay for the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers. Measurement of c-reactive protein aids in the evaluation of the amount of injury to body tissues.

The C-Reactive Protein Gen 3 assay is a particle enhanced turbidimetric assay. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies. The precipitate is determined turbidimetrically at 570 nm.