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The Axis-Shield Active-B12 (Holotranscobalamin) assay is an enzyme-immunoassay (EIA) for the quantitative determination of holotranscobalamin (HoloTC) in human serum. HoloTC (vitamin B12 bound to transcobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency.

The Axis-Shield Active-B12 (Holotranscobalamin) device contains the following components: a microtitre plate with 8 x 12-well breakapart strips coated with a anti-holotranscobalamin murine monoclonal antibody, in a resealable foil pack with desiccant; ready-to-use calibrators, low and high controls (phosphate buffer containing protein (bovine) stabiliser and sodium azide preservative with or without recombinant HoloTC); ready-to-use pre-treatment solution; murine anti-human transcobalamin alkaline phosphatase conjugate; para-NitroPhenyl Phosphate (pNPP) substrate; wash buffer (8x); ready-to-use stop solution.

Reagents: The ARCHITECT HbA1c assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of percent hemoglobin A1c (HbA1c) in human whole blood on the ARCHITECT i System. Percent HbA1c measurements are used for monitoring long term glycemic control in diabetic patients. Calibrators: The ARCHITECT HbA1c Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent haemoglobin A1c (HbA1c) in human whole blood.

The ARCHITECT HbA1c assay is a two-step pre-treatment immunoassay for the quantitative determination of percent haemoglobin A1c (% HbA1c) in human whole blood using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Sample is incubated with pre-treatment reagent to lyse the red blood cells. Pre-treated sample is the incubated with magnetic microparticles with a silica surface. Hemaglobin and HbA1c in the sample bind to the silica surface of the microparticles. Following a wash cvcle, anti-HbA1c acridinium-labeled conjugate is added to create a reaction mixture. Following another wash cycle, pre-trigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). The haemoglobin and HbA1c that are bound to the surface of the microparticles represents the total percentage present in the sample however, only the HbA1c result is required to determine the % HbA1c in the sample. A direct relationship exists between the amount of HbA1c in the sample and the RLUs detected by the ARCHITECT i System optics.

The 3-Reagent Homocysteine Assay for Beckman Coulter SYNCHRON® and UniCel® systems is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Bound or dimerised homocysteine (oxidised form) is reduced to free homocysteine, which then reacts with serine catalysed by cystathionine beta-synthase (CBS) to form cystathionine. Cystathionine in turn is broken down by cystathionine beta-lyase (CBL) to form homocysteine, pyruvate and ammonia. Pyruvate is then converted by lactate dehydrogenase (LDH) to lactate with nicotinamide adenine dinucleotide (NADH) as coenzyme. The rate of NADH conversion to NAD+ is directly proportional to the concentration of homocysteine (delta A340 nm).

The ARCHITECT Active-B12 (Holotranscobalamin) assay is a chemiluminescent microparticle immunoassay (CMIA) the for quantitative determination of Holotranscobalamin in human serum on the ARCHITECT i System. Active-B12 (Holotranscobalamin) is used as an aid in the diagnosis and treatment of vitamin B12 deficiency:

The ARCHITECT Active-B12 (Holotranscobalamin) assay is a two-step immunoassay for the quantitative determination of Holotranscobalamin in human serum using CMIA technology, with flexible assay protocols, referred to as Chemiflex. In the first step, sample and anti-holotranscobalamin coated paramagnetic microparticles are combined. Holotranscobalamin present in the sample binds to the antiholotranscobalamin coated microparticles. After washing, anti-transcobalamin acridinium-labeled conjugate is added-to create a reaction mixture in the second step. Following another wash cycle, pretrigger and trigger solutions are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of Holotranscobalamin in the sample and the RLUs detected by the ARCHITECT i System optics.

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 Liquid Stable (LS) 2-Part Homocysteine Reagent is intended for in vitro quantitative determination of total homocysteine in human serum and plasma. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

The Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent Test System includes two reagents and two calibrators. The first reagent (Reag 1) includes Lactate dehydrogenase (LDH), Serine, nicotinamide adenine dinucleotide reduced di-sodium salt (NADH), tris [2-carboxyethyl] phosphine (TCEP) reductant, with buffers and stabilizers (Trizma Base and Trizma Hydrochloride), and preservative (Sodium Azide). The second reagent (Reag2) includes Cystathionine beta-Synthase (CBS) and Cystathionine beta-Lvase (CBL) cvcling enzymes with preservative (sodium azide). The Axis-Shield Liquid Stable (LS) 2-Part Homocysteine Reagent kit will also include two calibrators; Calibrator "0" (0 µmol/L) and Calibrator "28" (28 µmol/L).

The ARCHITECT Homocysteine assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of total L-homocysteine in human serum or plasma on the ARCHITECT i System. Homocysteine values can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. The ARCHITECT Homocysteine Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of total L-homocysteine in human serum or plasma. The ARCHITECT Homocysteine Controls are for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System (reagents, calibrators and instrument), when used for the quantitative determination of total L-homocysteine in human serum or plasma. For in vitro diagnostic use.

The ARCHITECT Homocysteine assay is a one-step immunoassay for the quantitative determination of total L-homocysteine in human serum or plasma using CMIA technology, with flexible assay protocols, referred to as Chemiflex. Bound or dimerised homocysteine (oxidized form) is reduced by dithiothreitol (DTT) to free homocysteine, which is then converted to Sadenosyl homocysteine (SAH) by the action of the recombinant enzyme S-adenosyl homocysteine hydrolase (rSAHHase) in the presence of excess adenosine. The SAH then competes with acridinium-labeled S-adenosyl cysteine for particle-bound monoclonal antibody. Following a wash stage and magnetic separation, pre-trigger and trigger solutions are added to the reaction mixture and the resulting chemiluminescence is measured as relative light units (RLUs). An indirect relationship exists between the amount of homocysteine in the sample and the RLUs detected by the ARCHITECT i System optics.

The AxSYM HbA1c assay is an immunoassay for the quantitative determination of percent hemoglobin A1c (HbA1c) in whole blood samples on the AxSYM System. Percent HbA1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control. The AxSYM HbA1c Standard Calibrators are for the standard calibration of the AxSYM System when used for the quantitative determination of percent HbA1c in whole blood samples. The AxSYM HbA1c Controls are for the use in quality control to monitor the accuracy and precision of the AxSYM HbA1c assay when used for the quantitative determination of percent hemoglobin A1c (HbA1c) in whole blood samples on the AxSYM System. For in vitro diagnostic use.

The AxSYM HbA1c assay is an immunoassay for the quantitative determination of percent hemoglobin A1c (HbA1c) in whole blood samples on the AxSYM System. Percent HbA1c measurements are used in the clinical management of diabetes to assess the long-term efficacy of diabetic control. In the AxSYM HbA1c assay, whole blood sample is lysed, releasing hemoglobin and HbA1c analyte. Lysed sample is added to the glass fiber matrix that has been coated with Blocking Buffer in a previous step. Hemoglobin and HbA1c analyte are captured on the glass fiber matrix by the binding reaction that occurs between the analyte and the Blocking Buffer. HbA1c is quantified by measuring the amount of HbA1c analyte captured on the matrix cell, using a conjuqate of Anti-HbA1c and Alkaline Phosphatase as the signal-generating molecule, and the substrate, 4-Methylumbelliferyl Phosphate (MUP). The AxSYM HbA1c reagents and sample are pipetted in the following sequence: SAMPLING CENTER - The whole blood samples can be processed from AxSYM sample . cups or from primary blood collection tubes (fluoride oxalate and fluoride EDTA). Potassium EDTA blood collection tubes that have undergone a single freeze-thaw cycle may also be processed from AxSYM sample cups or from the primary blood collection tube. Fresh (non-frozen) potassium EDTA primary whole blood collection tubes may be used if testing is performed in STAT mode and run in groups of eight tubes or less. For further instructions on use of potassium EDTA whole blood samples, refer to the SAMPLE COLLECTION AND PREPARATION FOR ANALYSIS section. The sample and all AxSYM HbA1c reagents required for one test . are pipetted by the Sampling Probe into various wells of a Reaction Vessel (RV). The RV is immediately transferred into the Processing Center. Further pipetting is done in the Processing Center by the Processing Probe. PROCESSING CENTER - The whole blood sample is combined with the Lysis Buffer and . incubated for 450 seconds. - . The matrix cell is coated with Blocking Buffer. The lysed sample is diluted with Sample Diluent and transferred to . the matrix cell. Hemoglobin and the HbA1c analyte are captured on the glass fiber matrix through interactions with the blocking buffer overcoat. - . The matrix cell is washed to remove unbound materials. - . The Anti-HbA1c:Alkaline Phosphatase Conjugate is dispensed onto the matrix cell and binds to the analyte, forming an antigen-antibody complex. - . The matrix cell is washed to remove unbound materials. - . The substrate, 4-Methylumbelliferyl Phosphate, is added to the matrix cell and the fluorescent product is measured by the MEIA optical assembly. The concentration of HbA1c in the sample is determined using a previously generated calibration curve