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The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is an automated, immunoassay analyzer designed to perform in vitro diagnostic tests on clinical specimens. The MAGLUMI 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D (25-OH VD) in human serum and plasma using the MAGLUMI series Fully-auto chemiluminescence immunoassay analyzer, and the assay is used for an aid in assessment of vitamin D sufficiency.

MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer: The MAGLUMI X3 Fully-auto chemiluminescence immunoassay analyzer is a fully automated instrument system designed to perform in vitro diagnostic tests on clinical specimens. The system utilizes chemiluminescent technology and uses pre-packaged reagent packs for qualitative or quantitative analysis of the analytes in human samples. The analyzer performs automatic sample pipetting, reagent loading, incubation, washing, measurements, and result calculations. MAGLUMI 25-OH Vitamin D assay: MAGLUMI 25-OH Vitamin D kit consists of the following reagents: Magnetic Microbeads- coated with anti-25-OH VD antibody in PBS buffer, NaN3 (<0.1%). Calibrator Low- A low concentration of 25-OH VD antigen in Carbonate buffer, NaN3 (<0.1%). Calibrator High- A high concentration of 25-OH VD antigen in Carbonate buffer, NaN3 (<0.1%). Buffer- Acidic buffer ABEI Label- ABEI labeled with anti-25-OH VD antibody (~0.500 ug/mL) in PBS buffer, NaN3 (<0.1%). Control 1- A low concentration of 25-OH VD antigen in Carbonate buffer, NaN3 (<0.1%). Control 2- A high concentration of 25-OH VD antigen in Carbonate buffer, NaN3 (<0.1%).

ALFIS Vitamin D in conjunction with ALFIS-3 Analyzer is an enzyme-linked fluorescence immunoassay intended for in vitro diagnostic use at clinical laboratories for the quantitative measurement of Total 25-hydroxy Vitamin D (25-OH Vitamin D) in human serum, lithium heparin plasma and sodium heparin plasma. ALFIS Vitamin D is indicated to be used as an aid in the determination of Vitamin D sufficiency in adults. ALFIS-3 Analyzer is a fluorescence-scanning instrument using magnetic beads and alkaline phosphatase enzyme system for in vitro diagnostic use in conjunction with various ALFIS immunoassays intended for measuring the concentration of designated analytes in human blood and other specimens.

ALFIS Vitamin D Test Cartridge is a plastic structure molded in the form of a disposable, self-contained, unitized device which houses the 'magnetic bead', 'antibody-alkaline phosphatase-conjugator (Ab-ALP)', 'sample diluent', 'diethanolamine (DEA)', '4-Methylumbelliferyl phosphate (MUP)', 'washing buffer'; all of which are integral components of ALFIS Vitamin D test. ALFIS Vitamin D test cartridge is an elongated structure having 150.8 mm length, 17 mm width and 16 mm height. 'ALFIS Vitamin D Test ID Chip' is a flat, rectangular device with its main body measuring 23 mm × 27 mm. Half of the portion along the breadth of the main body is 5 mm thick while remaining half is 3 mm in thickness. Another rectangular portion measuring 12 mm × 10 mm × 2 mm protrudes out from the breadth of apical side of the 3 mm-thick portion of the main body. ALFIS Vitamin D Test ID Chip is an electronic memory device fitted into a plastic matrix. Lot-specific 'ALFIS Vitamin D Test ID Chip' is an integral component of ALFIS Vitamin D test system. ALFIS-3 analyzer is a compact, bench-top, automated, fluorometric analyzer measuring 422 mm (L) x 270 mm (W) x 292 mm (H). ALFIS-3 weighs 13.0 kg. ALFIS-3 analyzer is a fluorometer instrument of closed-system analyzer type. 'ALFIS Vitamin D Calibrators' needs to be tested by user laboratories for periodic calibration of ALFIS Vitamin D test system. 'ALFIS Vitamin D Controls' needs to be tested by user laboratories periodically for monitoring the performance of ALFIS Vitamin D test system.

The Access 25(OH) Vitamin D Total assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total 25-hydroxyvitamin D [25(OH) vitamin D] levels in human serum and plasma using the DxI Access Immunoassay Analyzers. Results are to be used as an aid in the assessment of vitamin D sufficiency.

The Access 25(OH) Vitamin D Total assay is a competitive binding immunoenzymatic assay. The Access 25(OH) Vitamin D Total assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffer. The Access 25(OH) Vitamin D Total assay reagent pack, Access 25(OH) Vitamin D Total assay calibrators, along with the UniCel Dxl Wash Buffer II are designed for use with the Dxl 9000 Access Immunoassav Analyzer in a clinical laboratory setting.

Binding assay for the in vitro quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on cobas e immunoassay analyzers.

Elecsys Vitamin D total III is a binding assay for the in vitro quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. The assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The assay is intended for use on the cobas e immunassay analyzers. The cobas e family of analyzers employ the electrochemiluminescence "ECLIA" technology. Elecsys Vitamin D total III utilizes a competition test principle and has a total test duration of 27 minutes: - 1st incubation: By incubating the sample (15 µL ) with pretreatment reagent 1 and 2, bound 25-hydroxyvitamin D is released from the vitamin D binding protein (VDBP). - 2nd incubation: By incubating the pretreated sample with the ruthenium labeled VDBP, a complex between the 25-hydroxyvitamin D and the ruthenylated VDBP is formed. A specific unlabeled antibody binds to 24,25-dihydroxyvitamin D present in the sample and inhibits cross-reactivity to this vitamin D metabolite. - 3rd incubation: After addition of streptavidin-coated microparticles and 25-hydroxyvitamin D labeled with biotin, unbound ruthenylated labeled VDBP become occupied. A complex consisting of the ruthenylated VDBP and the biotinylated 25-hydroxyvitamin D is formed and becomes bound to the solid phase via interaction of biotin and streptavidin. - The reaction mixture is aspirated into the measuring cell where the microparticles are magnetically captured onto the surface of the electrode. Unbound substances are then removed with ProCell/ProCell M. Application of a voltage to the electrode then induces chemiluminescent emission which is measured by a photomultiplier. Results are determined via a calibration curve which is instrument-specifically generated by a 2-point calibration and a master curve provided via the reagent barcode or e-barcode. The reagent working solutions include the reagent rackpack (M, R1, R2) and the pretreatment reagents (PT1, PT2); PT1 Pretreatment reagent 1 (white cap), 1 bottle, 4 mL: Dithiothreitol 1 g/L, pH 5.5 PT2 Pretreatment reagent 2 (gray cap), 1 bottle, 4 mL: Sodium hydroxide 57.5 g/L M Streptavidin-coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin-coated microparticles 0.72 mg/ml; preservative R1 Vitamin D binding protein-Ru/(bpy) (gray cap), 1 bottle, 9 mL: Ruthenium labeled vitamin D binding protein 150 µg/L; bis-tris propane buffer 200 mmol/L; albumin (human) 25 g/L; pH 7.5; preservative R2 25-hydroxyvitamin Dbiotin (black cap), 1 bottle, 8 5 mL: Biotinylated 25-hydroxyvitamin D 20 µg/L; bis-tris propane buffer 200 mmol/L; pH 8.6; preservative

The ADVIA Centaur® Vitamin D Total (VitD) assay is for in vitro diagnostic use in the quantitative determination of total 25(OH)vitamin D in human serum and plasma (EDTA, lithium heparin, sodium heparin) using the ADVIA Centaur® systems. The ADVIA Centaur® VitD assay is intended as an aid in the determination of vitamin D sufficiency.

The ADVIA Centaur® Vitamin D reagent kit comes in two configurations (100 or 500 test kit) and each kit contains the following: - ReadyPack® primary reagent pack containing ADVIA Centaur VitD Lite Reagent, Solid . Phase Reagent, and Ancillary Well Reagent - ReadyPack ancillary pack containing ADVIA Centaur VitD Ancillary Reagent . - . ADVIA Centaur VitD Low Calibrator - . ADVIA Centaur VitD High Calibrator - ADVIA Centaur systems VitD Master Curve card ● - ADVIA Centaur systems VitD Calibrator Assigned Value Card ● The VitD Reagents consists of the following: Lite Reagent 5.0 mL/reagent pack: The reagent contains anti-VitD (monoclonal mouse) antibody labeled with acridinium ester (~0.8 µg/mL) in buffer with bovine serum albumin, mouse IgG, and sodium azide (< 0.1%) Solid Phase Reagent 10.0 mL/reagent pack: The Solid Phase Reagent contains anti-fluorescein (monoclonal mouse)-coated paramagnetic particles (PMP) (~0.60 mg/mL) in buffer with bovine serum albumin, surfactant, and sodium azide (< 0.1%) Ancillary Well Reagent 5.0 mL/reagent pack: The Ancillary Well Reagent contains vitamin D-analog conjugated to fluorescein (~0.2 µg/mL) and 1-anilinonaphthalene-8-sulfonic acid in buffer with bovine serum albumin and sodium azide (< 0.1%) Ancillary Reagent Pack 25.0 mL/reagent pack: The Ancillary Reagent Pack contains releasing agent in buffered saline with sodium azide (<0.1%) and stabilizers The VitD Calibrators 2 x 2.0 mL/vial: After reconstitution, low or high levels of 25(OH)vitamin D in buffered, defibrinated human plasma with bovine serum albumin, cholesterol, preservatives, and sodium azide (<0.1%). Material Required but Not Provided - ADVIA Centaur Wash 1 . Optional Materials - ADVIA Centaur VitD Quality Control Material - . ADVIA Centaur VitD Diluent - . ADVIA Centaur VitD Master Curve Material (MCM)

MAGLUMI 2000 25-OH Vitamin D is an in vitro chemiluminescence immunoassay for the quantitative determination of 25-OH Vitamin D in human serum using Maglumi 2000 Fully-auto chemiluminescence immunoassay analyzer. The measurement of 25-OH Vitamin D is to be used as an aid in the assessment of vitamin D sufficiency.

MAGLUMI 2000 25-OH VITAMIN D kit consists of the following reagents: Magnetic Microbeads- coated with 25-OH Vitamin D monoclonal antibody, containing BSA, NaN3 (<0.1%) Calibrator Low-Containing BSA and 25-OH Vitamin D antigen, NaN3(<0.1%) Calibrator High- Containing BSA and 25-0H Vitamin D antigen, NaN3(<0.1%) Displacing Reagent- Acidic buffer ABEI Label- 25-OH Vitamin D antigen labeled with ABEI Control 1- Containing BSA and 25-OH Vitamin D antigen, NaN3 (<0.1%) Control 2- Containing BSA and 25-OH Vitamin D antigen, NaN3 (<0.1%)

The BioPlex 2200 25-OH Vitamin D Kit is a multiplex flow competitive immunoassay intended for the quantitative determination of 25-hydroxyvitamin D in human serum. The BioPlex 2200 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. The BioPlex 2200 25-OH Vitamin D kit is intended for use with the Bio-Rad BioPlex 2200 System.

BioPlex 2200 25-OH Vitamin D kit includes the following components: - One (1) 10 mL vial of Bead Set containing dyed beads coated with anti-25-0H ● Vitamin D antibody (sheep), an Internal Standard bead (ISB), and a Serum Verification bead (SVB) in buffer with protein stabilizers (bovine). ProClin 950 (< 1.0%) and sodium azide (< 0.1%) as preservatives. - One (1) 10 mL vial of Release Buffer containing 25-OH Vitamin D releasing reagents in citrate and tri sodium citrate acid buffer at pH 4.1 and ProClin 950 (<1.0%) as preservative. - One (1) 5 mL vial of Conjugate 1 containing biotinylated 25-OH Vitamin D . conjugate and biotinylated anti-human FXIII antibody conjugate (murine) in buffer with protein stabilizers (bovine). ProClin 950 (< 1.0%) and 5-bromo-5nitro-1, 3-dioxane (<0.1%) as preservatives and chemical blockers. - . One (1) 5 mL vial of Conjugate 2 containing phycoerythrin conjugated streptavidin (SA-PE) in a buffer comprising protein stabilizers (bovine). ProClin 950 (< 1.0%) and sodium azide (< 0.1%) as preservatives, chemical blockers and detergent (Tween 20). Additional materials required but not supplied include BioPlex 2200 Sheath Fluid containing Phosphate Buffered Saline (PBS), ProClin 300 (0.03%) and sodium azide (<0.1%) as preservatives; and BioPlex 2200 Wash Solution containing Phosphate Buffered Saline (PBS) and Tween 20. ProClin 300 (0.03%) and sodium azide (<0.1%) as preservatives.

The Diazyme EZ Vitamin D Assay is intended for use in clinical laboratories for the quantitative determination of 25hydroxyvitamin D (25-OH-D) in human serum and plasma on automated chemistry analyzers. Measurement of 25hydroxyvitamin D (25-OH-D) is for the assessment of vitamin D sufficiency. For in vitro diagnostic use only.

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The LOCI Vitamin D Total assay is an in vitro diagnostic test for the quantitative measurement of total 25(OH)yitamin D in human serum and plasma on the Dimension® EXL™ integrated chemistry system with LOCI® Module. Measurements of vitamin D are used in the assessment of vitamin D sufficiency. The LOCI VITD CAL is an in vitro diagnostic product for the calibration of the Vitamin D (VITD) Total assay on the Dimension® EXL™ integrated chemistry system with LOCI® module.

LOCI Vitamin D Total assay: The LOCI Vitamin D Total assay is a homogeneous competitive chemiluminescent immunoassay based on LOCI technology. The assay measures the total 25(OH)vitamin D concentration [comprising both 25(OH)vitamin D2 and 25(OH)vitamin D3] in both serum and plasma. LOCI Vitamin D Total reagents include a releasing reagent, biotinylated monoclonal antibody, and two synthetic bead reagents. Patient sample is incubated with the releasing reagent to release 25(OH)vitamin D molecules from the vitamin D-binding proteins. The reaction mixture is then incubated with biotinylated antibody to form a 25(OH)vitamin D/biotinylated antibody complex. Chemibeads containing 25(OH)vitamin D3 analog and chemiluminescent dye are added to remove the excess free biotinylated antibody. Streptavidin-coated Sensibeads containing a photosensitive dye are added to bind the biotinylated antibody. Aqqregates of the Chemibead analog/biotinylated antibody/streptavidin Sensibeads are formed as a result. Illumination of the reaction mixture by light at 680 nm generates singlet oxygen from the Sensibeads, which diffuses into the Chemibeads and triagers a chemiluminescent reaction. The resulting chemiluminescent signal is measured at 612 nm and is inversely proportional to the concentration of total 25(OH)vitamin D in the sample. LOCI VITD CAL: The LOCI VITD CAL is a five level, liquid, single analyte, frozen product, which is stored at -15 ℃ to -25 ℃. The calibrator matrix consists of processed human serum with preservatives and stabilizers. Level 1 is a zero level, while levels 2 3, 4, and 5 contain approximately 12, 30, 75, and 165 ng/mL respectively. Each lot of calibrators will have lot specific assigned values assigned from master pool levels that are traceable by method correlation to Ghent University's ID-LC/MS/MS 25(OH)vitamin D Reference Method Procedure (RMP). The ID-LC/MS/MS RMP is traceable to the NIST SRM 2972.

The Elecsys Vitamin D total II assay is intended for the quantitative determination of total 25-hydroxyvitamin D in human serum and plasma. This assay is to be used as an aid in the assessment of vitamin D sufficiency in adults. The electrochemiluminescence binding assay is intended for use on the cobas e 411 immunoassay analyzer. CalSet Vitamin D total II is used for calibrating the quantitative Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. PreciControl Vitamin D total II is used for quality control of the Elecsys Vitamin D total II assay on the cobas e 411 immunoassay analyzer. This CalCheck set is an assayed control for use in calibration verification of the assay range established by the Elecsys Vitamin D total II reagent on the cobas e 411 immunoassay analyzer.

Elecsys Vitamin D total II is a second generation assay by Roche Diagnostics for the in vitro quantitative determination of 25-hydroxyvitamin D in human serum and plasma. It is intended for use on the cobas e 411 immunoassay analyzer. The cobas e family of analyzers employs the electrochemiluminescence "ECLIA" technology. The assay is a 27 minute assay utilizing a competition principle and a pretreatment step to release the bound 25-hydroxyvitamin D from the vitamin D binding protein. Results are determined via a calibration curve which is instrument specifically generated by 2-point calibration against the master curve for that reagent lot.