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Immunoassay for the in vitro quantitation of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. This assay can be used intraoperatively. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers

Both the Elecsys PTH and Elecsys PTH STAT immunoassays make use of a sandwich test principle using a biotinylated monoclonal PTH-specific antibody labeled with a ruthenium complex. Both the Elecsys PTH and Elecsys PTH STAT immunoassays are intended for the in vitro quantitative determination of intact parathyroid hormone in human serum and plasma for the differential diagnosis of hypercalcemia and hypocalcemia. These assays can be used intraoperatively. They are intended for use on the cobas e immunoassay analyzers. Results are determined via a calibration curve which is instrument-specifically generated by a two-point calibration and a master curve provided via the reagent barcode. The reagent working solutions include: Rack Pack (kit placed on the analyzer) - M Streptavidin coated microparticles (transparent cap), 1 bottle, 6.5 mL: Streptavidin . coated microparticles 0.72 mg/mL; preservative. - . R1 Anti PTH Ab~biotin (gray cap), 1 bottle, 7 mL: Biotinylated monoclonal anti PTH antibody (mouse) 2.3 mg/L; phosphate buffer 100 mmol/L, pH 7.0; preservative. - . R2 Anti PTH Ab~Ru(bpy) (black cap), 1 bottle, 7 mL: Monoclonal anti PTH antibody (mouse) labeled with ruthenium complex 2.0 mg/L; phosphate buffer 100 mmol/L, pH 7.0; preservative.

The Access Intact PTH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of intact parathyroid hormone (parathyrin, PTH) levels in human serum and plasma using the Access Immunoassay Systems. It is indicated to aid in the differential diagnosis of hyperparathyroidism, hypoparathyroidism, or hypercalcemia of malignancy and can be used intraoperatively. Assay results should be used in conjunction with other clinical data to assist the clinician in making individual patient management decisions.

The Access Intact PTH assay is a sandwich immunoenzymatic assay. The Access Intact PTH assay consists of the reagent pack and calibrators. Other items needed to run the assay include substrate and wash buffers. The Access intact PTH assay reagent pack, Access intact PTH assay calibrators, along with the Access wash buffer and substrate are designed for use on the Dxl 9000 Access Immunoassay Analyzers in a clinical laboratory setting.

VITROS Immunodiagnostic Products Intact PTH II Reagent Pack quantitatively measures intact parathyroid hormone (iPTH) in human serum and plasma (K2-EDTA, lithium heparin) using the automated VITROS 3600 Immunodiagnostic System. Intact PTH is indicated to aid in the diagnosis of hyperparathyroidism, differential diagnosis of hypocalcemia or hypercalcemia and for intraoperative measurement of iPTH levels.

The VITROS Immunodiagnostic Products Intact PTH II assay is performed using the VITROS Intact PTH II Reagent Pack and the VITROS Intact PTH II Calibrators on the VITROS 3600 Immunodiagnostic System. VITROS Intact PTH II Reagent Pack contains: 1 reagent pack containing: - 100 coated wells (biotinylated anti-PTH antibody, 2ug/ml). ● - 7.4 mL assay reagent as buffer with bovine gamma globulin, bovine serum albumin, and antimicrobial agent. - 7.4 mL conjugate reagent (HRP-mouse monoclonal anti-PTH, 6 ug/mL) in buffer with bovine serum albumin and antimicrobial agent).

For in vitro diagnostic use. Lumipulse G whole PTH is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative measurement of PTH (1-84) in human serum and plasma on the LUMIPULSE G System. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

The Lumipulse G whole PTH Immunoreaction Cartridges consists of 3 × 14 tests. Each kit contains the following: 1) Antibody-Coated Particle Solution (Liquid when used, 200 µL/Immunoreaction Cartridge) Contains 200 µg/mL anti-PTH polyclonal antibodies (goated ferrite particles, protein stabilizers (bovine and goat) and chemical stabilizers in MES buffer. This solution contains gelatin and turns into gel at 15 °C or lower. Preservative: ProClin 300 2) Enzyme-Labeled Antibody Solution (Liquid, 120 µL/Immunoreaction Cartridge) Contains 0.2 µq/mL alkaline phosphatase (ALP: calf)-labeled anti-PTH polyclonal antibody (qoat), protein stabilizers (bovine) and chemical stabilizers in MES buffer. Preservative: ProClin 300

The ADVIA Centaur® Intact Parathyroid Hormone (PTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (PTH) in human serum and plasma using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism, or disorders of calcium metabolism. This assay can be used intra-operatively.

The ADVIA Centaur® Intact Parathyroid Hormone (PTH) assay is a chemiluminescence sandwich immunoassay. It consists of a Lite Reagent containing acridinium ester-labeled mouse monoclonal anti-human PTH antibody and a Solid Phase Reagent containing biotinylated mouse monoclonal anti-human PTH antibody bound to streptavidin-coated paramagnetic particles. The assay also includes Low and High Calibrators which are reconstituted synthetic peptide in buffered saline with human EDTA plasma, surfactants, and preservatives.

The IDS-iSYS Intact PTH+ assay is an in vitro diagnostic device intended for the quantitative determination of intact PTH in human serum or plasma on the IDS-iSYS Multi-Discipline Automated System. Results are to be used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism.

The IDS-iSYS Intact PTH" assay is based on chemiluminescence technology. 100 uL of patient sample is incubated with a biotinylated polyclonal anti-PTH (39-84) antibody and an acridinium labelled PTH (13-34) antibody. Streptavidin labelled magnetic particles are added prior to a second incubation step. The magnetic particles are captured using a magnet and a wash step performed to remove any unbound analyte. Trigger reagents are added; the resulting light emitted by the acridinium label is directly proportional to the concentration of Intact PTH in the original sample. IDS-iSYS Intact PTH reagent kit consists of one (1) Immunoassay Cartridge, two (2) vials each of 2 concentration Calibrator levels and a mini-CD containing the Instructions For Use (IFU), CRY files and Certificate of Analysis. IDS-iSYS Intact PTHN Cartridge, sufficient for 100 tests, consists of reagents provided in individual compartment within a plastic container called the Cartridge. The IDS-iSYS Intact PTHN Cartridge contains the following ready to use reagents: - · Magnetic particles coated with streptavidin in a phosphate buffer containing sodium azide as preservative (<0.1%), 1 bottle. - Goat polyclonal antibody against 13-34 PTH labelled with an acridinium ester derivative, in buffer containing goat serum with sodium azide as preservative (<0.1%), 1 bottle. - Goat polyclonal antibody against 39-84 PTH 1abelled with biotin, in buffer containing bovine and goat proteins with sodium azide as preservative (<0.1%), 1 bottle. IDS-iSYS Intact PTH Calibrators are included in the reagent kit. - · Calibrator A: Two vials of lyophilized porcine serum matrix buffer containing low level PTH and sodium azide as preservative >1% (w/w%). - · Calibrator B: Two vials of lyophilized porcine serum matrix buffer containing high level PTH and sodium azide as preservative >1% (w/w%). The submission is due to a new source of antibody for the assay.

The DiaSorin LIAISON® 1-84 PTH assay is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of parathyroid hormone (1-84) in human serum and EDTA plasma. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia resulting from disorders of calcium metabolism. The test has to be performed on the LIAISON® Analyzer. The DiaSorin LIAISON® 1-84 PTH Control Set is intended for in vitro diagnostic use as assayed quality control samples to monitor the accuracy and precision of the LIAISON® 1-84 PTH Assay. The DiaSorin LIAISON® 1-84 PTH Calibration Verifiers are assayed quality control materials intended for in vitro diagnostic use in the quantitative verification of calibration and reportable range of the LIAISON® 1-84 PTH Assay.

The LIAISON® 1-84 PTH Assay is a modified two-step, two-site sandwich assay that uses two polyclonal antibodies for capture and detection of the 1-84 PTH molecule. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of 1-84 PTH present in the calibrators, controls or samples. LIAISON® 1-84 PTH Control set contains; - 2 levels controls containing human plasma spiked with 1-84 PTH, and preservatives: 4 vials each level; lyophilized The target concentration for control level 1 is 30 pg/mL. The target concentration for control Level 2 is 260 pg/mL. The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® 1-84 PTH Control set. LIAISON® 1-84 PTH Calibration Verifier set contains: - 4 levels containing human plasma spiked with 1-84 PTH, with preservative, 1 vial each level, lyophilized. The target concentration for cal verifier A is 10 pg/mL. The target concentration for cal verifier B is 80 pg/mL. The target concentration for cal verifier C is 400 pg/mL. The target concentration for cal verifier D is 1450 pg/mL. The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® 1-84 PTH Calibration Verifier set.

The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur and ADVIA Centaur XP systems. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.

The ADVIA Centaur iPTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of an antihuman PTH antibody in the Lite Reagent and an antihuman PTH antibody in the Solid Phase Reagent. The first antibody is a polyclonal goat antihuman PTH (N-terminal 1-34) antibody labeled with acridinium ester. The second antibody is a biotinylated polyclonal goat antihuman PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles in the Solid Phase reagent.

The LIAISON® N-TACT® PTH Gen II is an in vitro chemiluminescent immunoassay (CLIA) intended for the quantitative determination of intact human parathyroid hormone in serum, EDTA and Lithium Heparin plasma samples. Measurements of parathyroid hormone levels are used in the differential diagnosis of hypercalcemia and hypocalcemia resulting from disorders of calcium metabolism. The test is to be performed on the LIAISON® XL Analyzer. The LIAISON® N-TACT® PTH Gen II Control Set is intended for use as assayed quality control samples to monitor the accuracy and precision of the DiaSorin LIAISON® N-TACT® PTH Gen II assay. The LIAISON® N-TACT® PTH Gen II Calibration Verifiers are assayed quality control materials intended for the quantitative verification of calibration and reportable range of the LIAISON® N-TACT® PTH Gen II assay.

The LIAISON® N-TACT® PTH Gen II assay is a modified two-step, two-site sandwich assay that uses two goat polyclonal antibodies for capture and detection of intact PTH. Results are determined by a 2 point calibration conversion of the master curve to a working curve. The light signal is measured by a photomultiplier as relative light units (RLU) and is proportional to the concentration of intact PTH present in the calibrators, controls or samples. LIAISON® N-TACT® PTH Gen II Control set contains: 2 levels controls containing 80% human plasma spiked with 1-84 PTH, and preservatives; 4 vials each level; lyophilized The target concentration for control level 1 is 20 pg/mL. The target concentration for control Level 2 is 300 pg/mL. The range of concentrations of each control is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Control set. LIAISON® N-TACT® PTH Gen II Calibration Verifier set contains: 4 levels containing 80% human plasma spiked with 1-84 PTH, with preservative, . 1 vial each level, lyophilized The target concentration for cal verifier A is 10 pg/mL. The target concentration for cal verifier B is 150 pg/mL. The target concentration for cal verifier C is 650 pg/mL. The target concentration for cal verifier D is 1600 pg/mL. The range of concentrations of each calibration verifier is reported on the certificate of analysis provided with each LIAISON® N-TACT® PTH Gen II Calibration Verifier set.

The ADVIA® Centaur Intact Parathyroid (iPTH) assay is for in vitro diagnostic use in the quantitative determination of intact parathyroid hormone (iPTH) in EDTA plasma or serum using the ADVIA Centaur XP system. This assay is intended to be used to aid in the differential diagnosis of hyperparathyroidism and hypoparathyroidism.

The ADVIA Centaur iPTH assay is a two-site sandwich immunoassay using direct chemiluminometric technology, which uses constant amounts of an antihuman PTH antibody in the Lite Reagent and an antihuman PTH antibody in the Solid Phase Reagent. The first antibody is a polyclonal goat antihuman PTH (N-terminal 1-34) antibody labeled with acridinium ester. The second antibody is a biotinylated polyclonal goat antihuman PTH (39-84 region) antibody that is preformed to streptavidin coated paramagnetic latex particles in the Solid Phase reagent. The ADVIA Centaur iPTH reagent kit contains the following: . ReadyPack® primary reagent pack containing ADVIA Centaur Lite and Solid Phase Reagent) ADVIA Centaur iPTH Master Curve card . Materials Required but Not Provided iPTH Calibrator . Optional Reagents ADVIA Centaur Multi-Diluent 11 . iPTH 1, 2, 3 quality control material . iPTH Master Curve Material .