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The Cystatin C assay is an in vitro diagnostic test used in the quantitative immunoturbidimetric determination of cystatin C in human serum and plasma on the Alinity c system. Measurement of cystatin C aids in the diagnosis and treatment of renal diseases. For laboratory professional use only.

The Cystatin C assay is an automated clinical chemistry assay. Cystatin C is a particle-enhanced turbidimetric immunoassay (PETIA) developed to accurately and reproducibly measure cystatin C levels in serum and plasma. Latex particles coated with anti-human cystatin C antibody agglutinate when mixed with sample containing human cystatin C. The change in absorbance due to agglutination of the reaction mixture is proportional to the quantity of human cystatin C in the sample.

The ADVIA® Chemistry Cystatin C 2 (CYSC 2) assay is for the in vitro diagnostic use in the quantitative determination of cystatin C in human serum and plasma (lithium heparin, potassium EDTA) on ADVIA Chemistry systems. Measurement of cystatin C aids in the diagnosis and treatment of renal disease.

The ADVIA Cystatin C_2 assay (CYSC_2) is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and plasma by means of particle-enhanced turbidimetry using the ADVIA Chemistry Systems. Used in conjunction with other clinical and laboratory findings, ADVIA Chemistry Cystatin C 2 measurements are used as an aid in the diagnosis and treatment of renal diseases. The ADVIA Chemistry Cystatin C 2 latex reagent is a suspension of uniform latex particles coated with anti-cystatin-C antibody. When serum or plasma containing cystatin C is mixed with the latex reagent, agglutination takes place resulting in an increase in turbidity. This turbidity is measured at 571 and 805 nm. The cystatin C concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators.

N Latex Cystatin C: N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and lithium-heparinized plasma by means of particle-enhanced immunonephelometry using the BN Systems. Cystatin C measurements are used in the diagnosis and treatment of renal diseases. N Protein Standard UY: N Protein Standard UY is used for preparing reference curves for the immunonephelometric determination of a1microglobulin and Cystatin C using the BN Systems.

The N Latex Cystatin C is an in vitro diagnostics kit containing reagents for the quantitative determination of cystatin C in human serum and lithium heparinized plasma by means of particle-enhanced immunonephelometry using the BN II and BN ProSpec® Systems. Used in conjunction with other clinical and laboratory findings, N Latex Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. Used in conjunction with the assay reagents, N Protein Standard UY is for use in the establishment of reference curves for the determination of cystatin C on the BN II and BN ProSpec Systems. N Cystatin C Control 1 and 2 are included with N Latex Cystatin C kit and are for use as assayed accuracy controls and precision controls in the determination of cystatin C by immunonephelometry with the BN II and BN ProSpec Systems. The N Latex Cystatin C test system is based upon the principles of particle-enhanced immunonephelometry. Polystyrene particles coated with specific antibodies to human cystatin C are aggregated when mixed with samples containing human cystatin C. These aggregates scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Tina-quant Cystatin Gen.2 is an in vitro test for the quantitative determination of cystatin C in human serum and plasma on Roche/Hitachi cobas c systems. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases.

The Roche Tina-quant Cystatin C Gen.2 assay provides quantitative measurement of the cystatin C that is present in human serum and plasma. The reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 (Reagent 1) and R2 (Reagent 2). R1 contains a solution of polymers in MOPS-buffered saline with preservative and stabilizers. R2 is latex particles coated with anti-cystatin C antibodies (rabbit) in glycine buffer with preservatives and stabilizers. Human cystatin C agglutinates with the antibody coated latex particles. The aggregate is determined turbidimetrically.

The Tina-quant Cystatin C Gen.2 is an in vitro test for the quantitative determination of cystatin C in human serum and plasma on Roche/Hitachi cobas c systems. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. Calibrator: The C.f.a.s. (Calibrator for automated systems) Cystain C is for use in the calibration of quantitative Roche methods on Roche clinical chemistry analyzers as specified in the value sheets. Control: The Cystatin C Control Set Gen.2 is for use in quality control by monitoring accuracy and precision for the quantitative methods as specified in the value sheets.

Roche Tina-quant Cystatin C Gen. 2 reagent provides quantitative measurement of the cystatin C that is present in human serum and plasma. Assay: Reagents are packaged in a cassette with two bottles labeled with their instrument positioning, R1 (Reagent 1) and R2 (Reagent 2). R I contains solution of polymers in MOPS-buffered saline; preservative, stabilizers. R2 is latex particles in glycine buffer coated with anti-Cystatin C antibodies (rabbit); preservative, stabilizers. Calibrator: C.f.a.s. Cystatin C is a liquid, ready-to-use calibrator based on pooled delipidated human serum enriched with recombinant human Cystatin C produced in E. Coli. Single level calibrators with lot specific values are diluted on board the analyzer to create a 6-point calibration curve. Control: Cystatin C Control Set contains 3 controls based on pooled delipidated human serum enriched with human recombinant Cystatin C produced in E. Coli.

Diazyme Cystatin C Point-of Care (POC) test reagents are intended for use with the SMART analyzer for the quantitative determination of Cystatin C in venous whole blood by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease. For in vitro Diagnostic Use Only. The Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Cystatin C POC Test. For in vitro Diagnostic Use Only.

Diazyme Cystatin C POC Test Kit contains reagents intended for use with the SMART analyzer for the quantitative determination of Cystatin C (Cys C) in human venous whole blood samples. Measurement of Cystatin C can assist in the assessment of renal transplantation status, monitoring GFR in nephrotoxic drug therapy, and monitoring GFR in acute and chronic kidney diseases including diabetic nephropathy. Cystatin C POC Test reagents are similar to the predicate Diazyme Cystatin C assay reagents (k093680). The similarities and differences in composition and format are noted in Table 1 below. The Cystatin C POC Test is based on a latex enhanced immunoturbidimetric assay. Cystatin C in the venous whole blood sample binds to the specific anti-Cystatin C antibody, which is coated on latex particles, and causes agglutination. The degree of the turbidity caused by agglutination can be measured optically and is proportional to the amount of Cystatin C in the venous whole blood sample. The Cystatin C concentration is expressed as mg/L Cystatin C by use of a lot specific calibration curve that is stored in an RFID card provided with each SMART test kit. Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Diazyme Cystatin C POC Test and is packaged separately. The controls are made from human venous whole blood and are in a lyophilized (freeze-dried) state. The quality controls assist laboratory users in verification steps ensuring that the assay reagents are functioning correctly. QC materials are run exactly as samples. Users are instructed to verify the calibration curve with the controls and run controls each time a new lot of reagents are received. If OC materials fall outside laboratory acceptable range, users are instructed to re-test and call manufacturer customer service if problem persists. SMART Analyzer (k092911) is a compact cuvette based spectrophotometer (10 inches x 5.5 inches x 5.5 inches) machine for point-of-care testing designed to analyze readings from single use reagent cuyette. The instrument only uses the Diazyme Reagent System (DRS) cuvette and caps and performs assay with a preprogrammed Radio Frequency ID (RFID) card. The DRS cuvette is supplied prefilled with Reagent 1 (R1) and the DRS cap is supplied prefilled with Reagent 2 (R2). The DRS cuvette and caps are kept separate until use. Users are instructed (see proposed labeling) to add 20ul of sample to the DRS cuvette prefilled with R1 containing proper amount of detergent for venous whole blood lysis. Users are then instructed to snap in place DRS cap and insert into analyzer. The instrument warms the cuvette to 37°C and after a predefined period adds the reagent R2 found in the DRS cap. The reagents and samples are mixed magnetically and absorbance readings are taken at 700nm. The lot specific RFID card contains reagent addition time, mixing time, reading time and calibration curve.

The K-ASSAY® Cystatin C Assay is for the quantitative determination of human cystatin C in serum, EDTA plasma, or lithium heparin plasma by immunoturbidimetric assay. Cystatin C measurements are used as an aid in the diagnosis and treatment of renal diseases. FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY® Cystatin C Calibrator is intended to be used for the calibration of the K-ASSAY® Cystatin C Assay. FOR IN VITRO DIAGNOSTIC USE. The K-ASSAY ® Cystatin C Control is intended for use as an assayed quality control material for monitoring the performance of cystatin C assays.

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The Diazyme Cystatin C Assay is an in-vitro diagnostic test for the quantitative determination of Cystatin C in serum or plasma by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease.

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Reagent: For in vitro diagnostic use in the quantitative determination of Cystatin-C (CYSC) in human serum or plasma (lithium heparin, potassium EDTA) on the ADVIA Chemistry systems. Measurement of Cystatin C aids in the diagnosis and treatment of renal disease. Calibrator: For in vitro diagnostic use in the calibration of Cystatin C method on ADVIA Chemistry systems.

The CYSC latex reagent is a suspension of uniform latex particles coated with anticystatin-C antibody. When serum or plasma containing cystatin C is mixed with the latex reagent, agglutination takes place resulting in an increase in turbidity. This turbidity is measured at 571 and 805 nm. The cystatin C concentration in serum or plasma is determined from a calibration curve that is generated with the calibrators.