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The Aptiva APS IgG Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (all2GPI) IgG autoantibodies in human serum as an aid in the diagnosis of primary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings. The Aptiva APS IgG Reagent is intended for use with the Aptiva System. The Aptiva APS IgM Reagent is an immunoassay utilizing particle-based multi-analyte technology for the semiquantitative determination of anti-cardiolipin (aCL) and anti-beta 2 glycoprotein 1 (aß2GPI) IgM autoantibodies in human serum as an aid in the diagnosis of primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory findings. The Aptiva APS IgM Reagent is intended for use with the Aptiva System.

The Aptiva APS IgG and Aptiva APS IgM reagent utilize particle based multi-analyte technology (PMAT) in a cartridge format. Each analyte (anti-cardiolipin [aCL] and anti-B2-Glycoprotein I [aB2GPI]) in the Aptiva APS IgG and Aptiva APS IgM reagent is a solid phase immunoassay utilizing fluorescent microparticles. This technology allows each of the two analytes, along with a human IgG or human IgM capture antibody (IgG or IgM Control Microparticle), to be coated onto three uniquely recognizable paramagnetic microparticles, which are combined into one tube. The Aptiva instrument is a fully automated, random-access analyzer. This platform is a closed system with continuous load and random-access capabilities that processes the samples, runs the reagent and reports results. It includes liquid handling hardware, optical module (OM), and integrated computer with proprietary software and touch screen user interface. The two analyte microparticles, along with the control microparticle, are stored in the reagent cartridge under conditions that proteins in their reactive states. When the assay cartridge is ready to be used for the first time, the reagent tube seals are pierced using the cartridge lid. The reagent cartridge is then loaded onto the Aptiva instrument, where the microparticles are automatically rehydrated using a buffer located within the cartridge. The Aptiva System dilutes the sample 1:8, then combines an aliquot of diluted sample, and reagent into a cuyette. The mixture is incubated at 37°C. After a wash cvcle, conjugated antihuman IgG or IdM antibodies are added to the particles and this mixture is incubated at 37°C. Excess conjugate is removed in another wash cycle, and the particles are re-suspended in system fluid. Multiple images are generated by the system to identify and count the two (2) unique analyte particles, as well as determine the amount of coniugate on each particle. Coated with goat anti-human lgG or IdM antibodies, is present as a control to flaq low concentrations of IgG or IgM in the sample as an assay verification step. The median fluorescent intensity (MFI) for each analyte is proportional to the concentration of conjugate bound to human IgG or IgM, which is proportional to the concentration of IgG or IgM antibodies bound to the corresponding particle population. The system uses the MFI from at least 50 particles of each population. The identity of the particles is determined by the unique signature of the particles. Each analyte in the Aptiva APS IgG Reagent and the Aptiva APS IgM Reagent is assigned a predefined lot specific master curve. The analyte specific master curve is stored on the reagent cartridge RFID label. Based on results obtained by running calibrators (supplied separately), the system creates individual working curves. Working curves are used by the software to calculate Fluorescent Light Units (FLU) for each analyte from the MFI values obtained for each sample. Aptiva APS IgG and Aptiva APS IgM Calibrators and Aptiva APS IgG and Aptiva APS IgM Controls are sold separately.

EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 100. EliA Cardiolipin IgA is intended for the in vitro semi-quantitative measurement of IgA antibodies directed to cardiolipin in human serum and plasma (heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgA uses the EliA IgA method on the instruments Phadia 250.

The new device belongs to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250. The conjugate for the EliA IgA method is mouse anti-human IgA beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgA calibration is based on a set of six WHO-standardized IgA Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method-specific and general reagents that are packaged as separate units.

The BioPlex®2200 Antiphospholipid Syndrome (APLS) IgM kit is a multiplex flow immunoassav intended for the semi-quantitative detection of IgM antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (B2GPI) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with clinical findings, the test system is used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders. The BioPlex 2200 APLS IgM kit is intended for use with the Bio-Rad BioPlex 2200 System. The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Calibrator Set is intended for the calibration of the corresponding BioPlex 2200 APLS IgM Reagent Pack. The BioPlex 2200 Antiphospholipid Syndrome (APLS) IgM Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and the corresponding BioPlex 2200 APLS IgM Reagent Pack in the clinical laboratory. The performance of the BioPlex 2200 APLS IgM Control Set has not been established with any other Antiphospholipid assay.

BioPlex® 2200 APLS IgM kit includes the following components: - o One (1) 10 mL vial of Bead Set containing two different populations of dyed beads coated with Cardiolipin (CL) and Beta-2-Glycoprotein I (B2GPI). an Internal Standard bead (ISB). a Serum Verification bead (SVB), and a Reagent Blank bead (RBB) in a MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with glycerol and protein stabilizers (porcine), and ProClin 300 (< 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. - One (1) 5 mL vial of Conjugate containing phycoervthrin conjugated murine . monoclonal anti-human IgM and phycoerythrin conjugated murine monoclonal anti-human FXIII in MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with protein stabilizers (bovine), and ProClin 300 (< 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. - One (1) 10 mL vial of Sample Diluent containing buffer with protein stabilizers . (bovine and murine), and ProClin 300 (< 0.3%). sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. BioPlex® 2200 APLS IgM Calibrator set contains seven 0.5 mL vials of human antibodies to CL or B2GPI in a human serum matrix made from defibrinated plasma with ProClin 300 (≤ 0.3%), sodium benzoate (< 0.1%) and sodium azide (< 0.1%) as preservatives. BioPlex® 2200 APLS [gM Control set contains four 1.5-mL vials of Positive controls of human antibodies to CL or ß2GPI and two vials of Negative Controls in a human serum matrix made from defibrinated plasma; and, in a human serum matrix made from defibrinated plasma with ProClin 300 (≤0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives. Additional materials required but not supplied include BioPlex® 2200 Sheath Fluid containing Phosphate Buffered Saline (PBS) with ProClin® 300 (0.03%) and sodium azide (<0.1%) as preservatives; and BioPlex® 2200 Wash Solution containing Phosphate Buffered Saline (PBS) and Tween 20 with ProClin® 300 (<0.03%) and sodium azide (<0.1%) as preservatives.

QUANTA Flash aCL IgA: Fully automated chemiluminescent immunoassay for the semiquantitative measurement of anti-cardiolipin (aCL) In human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome (APS), when used in conjunction with other laboratory and clinical findings. The QUANTA Flash aCL IgA Controls are intended for quality control purposes of the QUANTA Flash aCL IgA assay performed on the BIO-FLASH® instrument. Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-B2 glycoprotein-1 ((S2GP1) IgA antibodies in human citrated plasma and serum on the BIO-FLASH® instrument, as an aid in the diagnosis of thrombotic disorders related to primary and secondary antiphospholipid syndrome, when used in conjunction with other laboratory and clinical findings. The QUANTA Flash \$2GP1 IgA Controls are intended for the quality control purposes of the QUANTA Flash B2GP1 IgA assay performed on the BIO-FLASH® instrument.

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Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgA antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgG antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative or semi-quantitative detection of Cardiolipin IgM antibodies in human serum to aid in the diagnosis of antiphospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings. Enzyme linked immunoassay (ELISA) for the qualitative : detection of Cardiolipin IgA, IgG and IgM antibodies in human serum to aid in the diagnosis of anti-phospholipid syndrome (APS) and APS associated with systemic lupus erythematosus (SLE) in conjunction with other laboratory tests and clinical findings.

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The BioPlex® 2200 APLS IgG and IgA kits are multiplex flow immunoassays intended for the semi-quantitative detection of IgG and IgA antibodies to Cardiolipin (CL) and Beta-2 Glycoprotein I (ß2GPI) in human serum and plasma (lithium heparin, sodium heparin, and sodium citrate). In conjunction with other clinical findings, the test systems are used as an aid in the diagnosis of primary Antiphospholipid Syndrome (APS) and those secondary to systemic lupus erythematosus (SLE) or SLE-like disorders. The BioPlex 2200 APLS IgG and IgA kits are intended for use with the Bio-Rad BioPlex 2200 System

The BioPlex® 2200 APLS IgG and IgA 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. "APLS" is an acronym for Anti-Phospholipid Syndrome. Two (2) different populations of dyed beads are coated with the antigens associated with Cardiolipin (CL) and Beta-2-Glycoprpotein I (ß2GPI), respectively. The BioPlex 2200 System combines an aliquot of patient sample, sample diluent, and bead reagent into a reaction vessel. The mixture is incubated at 37°C. After a wash cycle, anti-human IgG or IgA antibody, conjugated to phycoerythrin (PE) is added to the dyed beads and this mixture is incubated at 37℃. The excess conjugate is removed in another wash cycle, and the beads are re-suspended in wash buffer. The bead mixture then passes through the detector. The identity of the dyed beads is determined by the fluorescence of the dyes, and the amount of analyte captured is determined by the fluorescence of the attached PE. Raw data is calculated in relative fluorescence intensity (RFI). Three additional dyed beads, an Internal Standard Bead (ISB), a Serum Verification Bead (SVB) and a Reagent Blank Bead (RBB) are present in each reaction mixture to normalize detector response, to verify the addition of serum to the reaction vessel and the absence of significant non-specific binding in serum or plasma. Refer to the BioPlex 2200 System Operation Manual for more information. The instrument is calibrated using a set of seven (7) distinct calibrator vials for APLS IgG kit and a set of three (3) distinct calibrator vials for the APLS IgA kit, all supplied separately by Bio-Rad Laboratories. For each aCL IgG and aß2GPI IgG, four (4) vials representing four (4) different antibody concentrations are used for semi-quantitative calibration. For each aCL IgA and aß2GPI IgA assay, two (2) vials representing two (2) different antibody concentrations are used for semi-quantitative calibration. The cut-off value and assignment of the calibrators are determined by performing concordance testing and Receiver Operator Characteristic (ROC) analysis, using clinical diagnosis as the standard. The results for aCL IgG and aCL IgA are expressed in GPL-U/mL and APL-U/mL units, respectively. The results for aß2GPI IgG and aß2GPI IgA are each expressed in U/mL units. The APLS IgG and APLS IgA Control Sets are intended for use as an assayed quality control to monitor the overall performance of the BioPlex® 2200 instrument and BioPlex 2200 APLS IgG and IgA reagent packs in the clinical laboratory. Each of the APLS IgG and APLS IgA Control Sets includes a negative control and a positive control for each aCL IgG or IgA and aß2GPI IgG or IgA in a human serum matrix made from defibrinated plasma, containing antibodies present for analytes within the APLS IgG or IgA kit. The positive controls are manufactured to give positive results. with values above the cutoff for each specific bead. The negative control is manufactured to give negative results, with values below the cutoff for each specific bead. The negative control must have a negative result, and the positive control must have a positive result.

The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is intended for the in vitro, qualitative measurement of IgG, IgM and/or IgA antibodies directed to cardiolipin in human serum to aid in the diagnosis of primary antiphospholipid syndrome (PAPS) and secondary antiphospholipid syndrome (SAPS) in conjunction with other laboratory and clinical findings.

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1) EliA Cardiolipin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the the EliA IgG method on the instruments Phadia 100 and Phadia 250. 2) EliA Cardiolipin IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgM uses the the EliA IgM method on the instruments Phadia 100 and Phadia 250. 3) EliA B2-Glycoprotein I IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to B2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) a as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgG uses the the EliA IgG method on the instruments Phadia 100 and Phadia 250. 4) EliA B2-Glycoprotein I IgM is intended for the in vitto semi-quantitative measurement of IgM antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgM uses the the EliA IgM method on the instruments Phadia 100 and Phadia 250. 5) EliA APS Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and B2-Glycoprotein I with Phadia 100 using the EliA IgG or IgM method. 6) EliA APS Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and ß2-Glycoprotein I with Phadia 250 using the EliA IgG or IgM method.

The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments Phadia 100 and Phadia 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbellifery I-BD-Galactoside as substrate. The conjugate for the EliA IgM method is mouse anti-human IgM beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate. The total IgG and IgM calibration is based on a set of six WHO-standardized IgG and IgM Calibrators, respectively, derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test. system includes test-, method-specific and general reagents that are packaged as separate units.

HemosIL AcuStar Anti-Cardiolipin IgG: Fully automated chemiluminescent immunoassay for the . semi-quantitative measurement of anti-cardiolipin (aCL) IgG antibodies in human citrate plasma and serum on the ACL™ AcuStar as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. . HemosIL AcuStar Anti-Cardiolipin IgM: Fully automated chemiluminescent immunoassay for the semi-quantitative measurement of anti-cardiolipin (aCL) IgM antibodies in human citrated plasma and serum on the ACL™ AcuStar, as an aid in the diagnosis of thrombotic disorders related to primary and secondary Antiphospholipid Syndrome (APS) when used in conjunction with other laboratory and clinical findings. HemosIL AcuStar Anti-Cardiolipin IgG Controls: For the quality control of the Anti-Cardiolipin . IgG assay performed on the ACL AcuStar. HemosIL AcuStar Anti-Cardiolipin IgM Controls: For the quality control of the Anti-Cardiolipin . IgM assay performed on the ACL AcuStar.

HemosIL AcuStar Anti-Cardiolipin IgG is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with cardiolipin and human purified B2GPI which capture, if present, the aCL antiphospholipid antibodies from the sample. After incubation, magnetic separation and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgG antibody is added and may bind with the captured aCL IgG on the particles. After a second incubation, magnetic separation, and wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the aCL IgG concentration in the sample. The ACL AcuStar aCL IgG assay utilizes a 4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve. The Master Curve is predefined and lot dependent and it is stored in the instrument through the cartidge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the calibrator tube barcodes. Hemos L AcuStar Anti-Cardiolipin IgM is a chemiluminescent two-step immunoassay consisting of magnetic particles coated with cardiolipin and human purified B2GPI which capture, if present, the aCL antiphospholipid antibodies from the sample. After incubation, magnetic separation, and a wash step, a tracer consisting of an isoluminol-labeled anti-human IgM antibody is added and may bind with the captured aCL IgM on the particles. After a second incubation, magnetic separation, and wash step, reagents that trigger the luminescent reaction are added, and the emitted light is measured as relative light units (RLUs) by the ACL AcuStar optical system. The RLUs are directly proportional to the aCL IgM concentration in the sample. The ACL AcuStar aCL IgM assay utilizes a 4 Parameter Logistic Curve (4PLC) fit data reduction method to generate a Master Curve. The Master Curve is predefined and lot dependent and it is stored in the instrument through the cartridge barcode. With the measurement of calibrators, the predefined Master Curve is transformed to a new, instrument specific 4PLC Working Curve. The concentration values of the calibrators are included in the calibrator tube barcodes. Hemos L AcuStar Anti-Cardiolipin IgG Controls: The Low and High Anti-Cardiolipin IgG Controls are prepared by means of a dedicated process and contain different concentrations of human aCL IgG antibodies. Low Anti-Cardiolipin IgG Control: Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off aCL IgG levels. High Anti-Cardiolipin IgG Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal aCL IgG levels. Hemos L AcuStar Anti-Cardiolipin IgM Controls: The Low and High Anti-Cardiolipin IgM ● Controls are prepared by means of a dedicated process and contain different concentrations of human aCL IgM antibodies. Low Anti-Cardiolipin IgM Control: Control intended for the assessment of precision and accuracy of the assay at the normal or around cut-off aCL IgM levels. High Anti-Cardiolipin IgM Control: Control intended for the assessment of precision and accuracy of the assay at the abnormal aCL IgM levels.

The TheraTest EL-aCL™screen and TheraTest EL-aCL™ IgM, InG, IgA are intended for use in clinical laboratories as an in vitro diagnostic test for the detection and measurement of autoantibodies in human serum directed against the phospholipid cardiolipin.

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