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The ADVIA Centaur® anti-CCP IgG (aCCP) assay is for in vitro diagnostic use in the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum or plasma (K2-EDTA and lithium heparin) using the ADVIA Centaur XP system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments. Quality Control: The ADVIA Centaur® Anti-CCP IgG (aCCP) quality control material is for in vitro diagnostic use to monitor the precision and accuracy of the ADVIA Centaur aCCP assay using the ADVIA Centaur systems. Master Curve Material (MCM): The ADVIA Centaur® Anti-CCP IgG (aCCP) Master Curve Material (MCM) is for in vitro diagnostic use in the verification of calibration and reportable range of the ADVIA Centaur aCCP assay.

The ADVIA Centaur aCCP assay is a fully automated, two-step immunoassay using chemiluminescent technology. The assay utilizes an acridinium ester-labeled anti-human lgG as the Lite Reagent. The Solid Phase consists of biotinylated CCP coupled to streptavidin which is then coated onto magnetic latex microparticles.

QUANTA Flash CCP3 is a chemiluminescent immunoassay for the semi-quantitative determination of IgG anti-CCP3 antibodies in human serum. The presence of anti-CCP3 antibodies, in conjunction with clinical findings and other laboratory tests, is an aid in the diagnosis of rheumatoid arthritis. QUANTA Flash CCP3 Calibrators are intended for use with the QUANTA Flash CCP3 chemiluminescent immunoassay for the determination of IgG anti-CCP3 antibodies in human serum. Each calibrator establishes a point of reference for the working curve that is used to calculate unit values. QUANTA Flash CCP3 Controls are intended for use with the QUANTA Flash CCP3 chemiluminescent immunoassay for quality control in the determination of IgG anti-CCP3 antibodies in human serum.

The QUANTA Flash CCP3 assay is designed to run on the BIO-FLASH® instrument. This platform is a fully automated closed system with continuous load and random access capabilities that automatically processes the samples, runs the assay and reports the results. It includes liquid handling hardware, luminometer and computer with software-user interface. The QUANTA Flash CCP3 assay utilizes a reagent cartridge format, which is compatible with the BIO-FLASH instrument. Synthetic cyclic citrullinated peptide is coated onto paramagnetic beads. The bead suspension is lyophilized and stored in the bead tube. Prior to use in the BIO-FLASH system, the sealed reagent tubes are pierced with the reagent cartridge lid and the beads are rehydrated and resuspended using resuspension buffer by pipetting up and down with a transfer pipette. The reagent cartridge is then loaded onto the BIO-FLASH instrument. Samples are also loaded onto the instrument in sample racks. Serum samples are diluted by the BIO-FLASH with system rinse in a small disposable plastic cuvette. Small amounts of the diluted patient serum, the beads, and assay buffer are combined into a second cuvette, and mixed. This cuvette is then incubated at 37°C. The beads are magnetized and washed several times. Isoluminol conjugated anti-human IgG antibodies are then added to the cuvette, and again incubated at 37°C. The beads are magnetized and washed repeatedly. The isoluminol conjugate is oxidized when Trigger 1 (Fe(II)coproporphyrin in sodium hydroxide solution) and Trigger 2 (ureahydrogen peroxide in sodium chloride solution) are added to the flash of light produced from this reaction is measured as Relative Light Units (RLU) by the BIO-FLASH optical system. The RLU are proportional to the amount of isoluminol conjugate that is bound to the human IgG, which is in turn proportional to the amount of anti-CCP3 antibodies bound to the corresponding beads. For quantitation, the QUANTA Flash CCP3 assay utilizes a predefined lot specific Master Curve that is uploaded onto the instrument through the reagent cartridge barcode. Every new lot number of reagent cartridge must be calibrated before first use, with the QUANTA Flash CCP3 Calibrators. Based on the results obtained with the two Calibrators included in the Calibrator Set (sold separately), an instrument specific Working Curve is created, which is used to calculate chemiluminescent units (CU) from the instrument signal (RLU) obtained for each sample. The QUANTA Flash CCP3 kit contains the following materials: One (1) QUANTA Flash CCP3 Reagent Cartridge One (1) vial of Resuspension buffer One (1) Transfer pipette The QUANTA Flash CCP3 reagent cartridge contains the following reagents for 100 determinations: - a. CCP3 coated paramagnetic beads, lyophilized. - b. Assay buffer - colored pink, containing Tris-buffered saline, Tween 20, protein stabilizers and preservatives. - C. Tracer IgG - Isoluminol labeled anti-human IgG antibodies in buffer, containing protein stabilizers and preservative. The QUANTA Flash CCP3 Calibrators kit contains two vials of Calibrator 1 and two vials of Calibrator 2: QUANTA Flash CCP3 Calibrators: - QUANTA Flash CCP3 Calibrator 1: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to CCP3 in stabilizer and preservative. - QUANTA Flash CCP3 Calibrator 2: Two (2) barcode labeled tubes containing 0.7 mL prediluted, ready to use reagent. Calibrators contain human antibodies to CCP3 in stabilizer and preservative. The QUANTA Flash CCP3 Controls kit contains two vials of Negative Control and two vials of Positive Control: QUANTA Flash CCP3 Controls: - QUANTA Flash CCP3 Negative Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to CCP3 in stabilizer and preservative. - QUANTA Flash CCP3 Positive Control: Two (2) barcode labeled tubes containing 0.5 mL, ready to use reagent. Controls contain human antibodies to CCP3 in stabilizer and preservative.

The IMMULITE 2000 Anti-CCP IgG assay is an in vitro diagnostic immunoassay for the semi-quantitative determination of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA or lithium heparin) on the IMMULITE 2000 system. Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA) and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criteria diagnostic process, encompassing both clinical and laboratory-based assessments. The IMMULITE 2000 Anti-CCP IgG Calibration Verification Material (CVM) is for in vitro diagnostic use, as a control for calibration verification of the IMMULITE 2000 Anti-CCP IgG assay on the IMMULITE 2000 system.

The IMMULITE 2000 Anti-CCP IgG assay consists of the following components: - Anti-CCP IgG bead pack coated with cyclic citrullinated peptide . (CCP) antigen - Anti-CCP IgG reagent wedge containing bovine calf intestine . conjugated to a monoclonal murine anti-human IgG antibody - Anti-CCP IgG adjustors, low and high, containing lyophilized . human serum with IgG reactive to CCP - Anti-CCP IgG controls, negative and positive, containing human . serum - . Autoantibody sample diluent containing protein/buffer matrix The IMMULITE Anti-CCP IgG Calibration Verification Material consists of one set of four vials, containing low, intermediate and high levels of lyophilized human serum with IgG reactive to cyclic citrullinated peptide (CCP), in buffer with preservative, plus an anti-CCP-free sample.

The BioPlex® 2200 Anti-CCP kit is a multiplex flow immunoassay intended for the semiquantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum or plasma (EDTA and sodium heparin). Detection of CCP antibodies is used as an aid in the diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical findings and laboratory results. The BioPlex® 2200 Anti-CCP kit is intended for use with the Bio-Rad BioPlex® 2200 System.

The BioPlex® 2200 Anti-CCP kit uses multiplex flow immunoassay, a methodology that permits simultaneous detection and identification of antibodies in a single tube. "CCP IgG" is an acronym for the detection of IgG antibodies to Cyclic Citrullinated Peptide. One (1) population of fluorescent beads is coated with antigens associated with cyclic citrullinated peptide (CCP). The BioPlex® 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel and incubates the mixture. After a wash cycle to remove unbound antibody, anti-human IgG conjugated to phycoerythrin is added and the mixture is incubated at 37°C. Excess conjugate is removed in another wash cycle and the washed beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the assay and control beads is determined by the fluorescence embedded in the surface of the bead and the amount of immobilized antibody is determined by the fluorescence of the anti-IgG reporter conjugate. Raw data are calculated in relative fluorescence intensity (RFI). Three additional dyed beads, Internal Standard Bead (ISB), Serum Verification Bead (SVB) and Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction and the absence of significant non-specific binding. Refer to the BioPlex® 2200 System Operation Manual for more information. The instrument is calibrated using a set of six (6) distinct calibrator vials, supplied separately by Bio-Rad Laboratories.

The Axis-Shield Anti-CCP test is a semi-quantitative/qualitative enzyme-linked immunosorbent assay (ELISA) for the detection of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum (including Serum Separator Tubes) or plasma (EDTA, lithium heparin, or sodium citrate). Detection of anti-CCP antibodies is used as an aid in the diagnosis of Rheumatoid Arthritis (RA), and should be used in conjunction with other clinical information. Autoantibody levels represent one parameter in a multi-criterion diagnostic process, encompassing both clinical and laboratory-based assessments. For in vitro diagnostic use.

The Axis-Shield Anti-CCP device contains the following components: a microtitre plate with 8 x 12-well breakapart strips coated with purified synthetic cyclic citrullinated peptide, in a resealable foil pack with desiccant; ready to use calibrators (diluent with or without IqG antibodies against CCP2); positive and negative assay controls (human plasma with or without IgG antibodies against CCP); ready-to-use reference control; goat anti-human IgG horseradish peroxidase conjugate: TMB substrate; sample diluent (5x) wash buffer (10x); ready-to-use stop solution.

The Euro-Diagnostica CCPoint® test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The results of the test are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by trained laboratory professionals. For in vitro diagnostic use.

The Euro-Diagnostica CCPoint® test is a visually read, qualitative rapid lateral flow test for the detection of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human serum or plasma. The results of the test are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. For use by trained laboratory professionals. For in vitro diagnostic use. The CCPoint® test is a colloidal gold based lateral flow immunoassay. Reactive cyclic citrullinated peptides are immobilised as a discrete line on a porous membrane located in the test zone. The detection reagent, consisting of colloidal gold particles conjugated to anti-human IgG, is deposited within the device onto the conjugate pad. In the assay procedure, a sample of serum or plasma is added to the sample port. A blood cell separation membrane transfers the sample fluid onto the porous membrane. After a short incubation running buffer is added to the buffer port. This buffer mobilizes the colloidal gold particles from the conjugate pad. The gold particles and the sample move by capillary force across the membrane. If the sample contains anti-CCP antibodies they will bind to the peptide-antigens and a red line will appear in the test zone (marked T). If the sample does not contain any anti-CCP antibodies no line will appear. With any sample a red control line should appear in the control zone (marked C). The control ensures that the coated colloidal gold is still active.

The BioPlex™ 2200 Anti-CCP Kit is a multiplex flow immunoassay intended for the semi-quantitative detection of IgG antibodies to Cyclic Citrullinated Peptide (CCP) in human serum and EDTA or heparinized plasma. Detection of CCP antibodies may be used as an aid in the diagnosis of rheumatoid arthritis and should be used in conjunction with other clinical information. The BioPlex 2200 Anti-CCP kit is intended for use with the Bio-Rad BioPlex 2200 system. The BioPlex™ 2200 Anti-CCP Calibrator Set is intended for the calibration of the BioPlex 2200 Anti-CCP Reagent Pack. The BioPlex™ 2200 Anti-CCP Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 instrument and BioPlex 2200 Anti-CCP Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 Anti-CCP Control Set has not been established with any other Anti-CCP assay.

The BioPlex™ 2200 Anti-CCP IgG kit uses multiplex flow immunoassay, a methodology that greatly resembles traditional EIA, but permits simultaneous detection and identification of many antibodies in a single tube. "CCP IgG" is an acronym for the detection of IgG antibodies to Cyclic Citrullinated Peptide. One (1) population of fluorescent beads is coated with antigens associated with cyclic citrullinated peptide (CCP). Three populations of fluorescent beads function as assay controls (see below). The BioPlex™ 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel and incubates the mixture at 37°C. After a wash cycle to remove unbound antibody, anti-human IgG conjugated to phycoerythrin is added and the mixture is incubated at 37°C. Excess conjugate is removed in another wash cycle and the washed beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the assay and control beads is determined by the fluorescence embedded in the surface of the bead and the amount of immobilized antibody is determined by the fluorescence of the anti-IgG reporter conjugate. Raw data are calculated in relative fluorescence intensity (RFI). Three additional dyed beads, Internal Standard Bead (ISB), Serum Verification Bead (SVB) and Reagent Blank Bead (RBB) are present in each reaction mixture to verify detector response, the addition of serum or plasma to the reaction and the absence of significant non-specific binding. Refer to the BioPlex™ 2200 System Operation Manual for more information. The instrument is calibrated using a set of six distinct calibrator vials, supplied separately by Bio-Rad Laboratories. The six vials representing six different analyte concentrations are used for calibration. The cut-off value and assignment of the calibrators are determined by performing concordance and Receiver Operator Characteristic (ROC) analysis using Axis-Shield DIAStat Anti-CCP predicate results as the reference. The result for anti-CCP is expressed as arbitrary units (U/mL). Results of <3 U/mL are negative and results of > 3 U/mL as positive. The BioPlex 2200 Anti-CCP Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Anti-CCP Reagent Pack in the clinical laboratory. The Control Set includes a negative and a positive control. The BioPlex Anti-CCP Positive Control is manufactured to give positive results, with values above the cut-off for the analyte. The BioPlex Anti-CCP Negative Control is manufactured to give negative results, with values below the cut-off for the analyte. The recommended frequency for performing quality control is once every 24-hour testing period. Performing quality control is also necessary after each new assay calibration and certain service procedures.

The TheraTest EL-anti-CCP/2™ test is intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of the IgG class of autoantibodies specific to cyclic citrullinated peptide (CCP) in human serum by enzyme-linked immunosorbent assay (ELISA). It is intended to aid in the diagnosis of Rheumatoid arthritis (RA) in conjunction with other clinical findings and laboratory tests.

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The Immunoscan CCPlus® test kit is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals. "For in vitro diagnostic use".

The Immunoscan CCPlus® test kit is a modification of the Immunoscan RA anti-CCP Test kit, K052133. It is an enzyme-linked immunosorbent assay (ELISA) for qualitative and semi-quantitative determination of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera. The assay is used to detect antibodies in a single serum specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals. "For in vitro diagnostic use". The wells are coated with Cyclic Citrullinated Peptides. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating. The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase labelled antibodies to human IgG binds to the antibodies in the wells in this second incubation. After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the colour intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.