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Lumipulse G HE4 Immunoreaction Cartridges: For in vitro diagnostic use. Lumipulse G HE4 is a Chemiluminescent Enzyme Immunoassay (CLEIA) for the quantitative determination of HE4 in human serum and plasma (lithium heparin or dipotassium EDTA) on the Lumipulse G System. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 values should be used in conjunction with other clinical methods used for monitoring epithelial ovarian cancer. Lumipulse G HE4 Calibrators: Lumipulse G HE4 Calibrators are for use in the calibration of the Lumipulse G System for the quantitative measurement of HE4 in human serum and plasma (lithium heparin or dipotassium EDTA).

The Lumipulse G HE4 is an assay system, including a set of immunoassay reagents, for the quantitative measurement of HE4 in specimens based on CLEIA technology by a two-step sandwich immunoassay method on the LUMIPULSE G System.

The Elecsys HE4 assay is an immunoassay for the quantitative determination of HE4 in human serum and plasma. The assay is used as an aid in monitoring the recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical findings used for monitoring ovarian cancer. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

The Elecsys HE4 assay is a sandwich immunoassay which includes a biotinylated monoclonal, murine HE4-specific IgG antibody as capture and a ruthenium labeled monoclonal, murine HE4-specific IgG antibody as signal.

The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. For In Vitro Diagnostic Use Only. Fujirebio Diagnostics Tumor Marker Control is intended for use as an assayed control serum to monitor the precision of laboratory testing procedures for the analytes listed in the lot specific assigned values sheet.

The Fujirebio Diagnostics Tumor Marker Controls are used for validation of each HE4 EIA assay series. The HE4 EIA results should be considered valid if the mean HE4 values of control duplicates are within the specified HE4 EIA ranges indicated on the Assigned Value Sheet provided with the Fujirebio Diagnostics Tumor Marker Controls.

The ARCHITECT HE4 assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of HE4 antigen in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer. The ARCHITECT HE4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum. The ARCHITECT HE4 Controls are used for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum.

The ARCHITECT HE4 assay is a two-step immunoassay for the quantitative determination of HE4 antigen in human serum using CMIA technology with flexible assay protocols, referred to as Chemiflex. In the first step, sample and 2H5 anti-HE4 coated paramagnetic microparticles are combined. HE4 antigen present in the sample binds to the anti-HE4 coated microparticles. After washing, 3D8 anti-HE4 acridinium-labeled conjugate is added to create a reaction mixture in the second step. 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). A direct relationship exists between the amount of HE4 antigen in the sample and the RLUs detected by the ARCHITECT i System optics. The ARCHITECT HE4 Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum. The ARCHITECT HE4 Controls are used for the verification of the accuracy and precision of the ARCHITECT i System when used for the quantitative determination of HE4 antigen in human serum.

The HE4 EIA is an enzyme immunometric assay for the quantitative determination of HE4 in human serum. The assay is to be used as an aid in monitoring recurrence or progressive disease in patients with epithelial ovarian cancer. Serial testing for patient HE4 assay values should be used in conjunction with other clinical methods used for monitoring ovarian cancer.

The HE4 EIA is a solid-phase, non-competitive immunoassay based upon the direct sandwich technique based on two mouse monoclonal antibodies, 2H5 and 3D8, directed against two epitopes in the C-WFDC domain of HE4. Calibrators, controls and patient samples are incubated together with biotinylated Anti-HE4 monoclonal antibody (MAb) 2H5 in streptavidin coated microstrips. HE4 present in calibrators or samples is adsorbed to the streptavidin coated microstrips by the biotinylated Anti-HE4 MAb during the incubation. The strips are then washed and incubated with HRP labeled Anti-HE4 MAb 3D8. After washing, buffered Substrate/Chromogen reagent (hydrogen peroxide and 3, 3', 5' tetra-methyl-benzidine) is added to each well and the enzyme reaction is allowed to proceed. During the enzyme reaction a blue color will develop if antigen is present. The intensity of the color is proportionate to the amount of HE4 present in the samples. The color intensity is determined in a microplate spectrophotometer at 620 nm (or optionally at 405 nm after addition of Stop Solution). Calibration curves are constructed for each assay by plotting absorbance value versus the concentration for each calibrator. The HE4 concentrations of patient samples are then read from the calibration curve.