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The ADVIA Centaur® Anti-Müllerian Hormone (AMH) assay is for in vitro diagnostic use in the quantitative determination of anti-Müllerian hormone (AMH) in human serum and plasma (lithium heparin) using the ADVIA Centaur® XP system. The measurement of AMH is used as an aid in the assessment of the ovarian reserve in women presenting to fertility clinics. This assay is intended to distinguish between women with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve). This assay is intended to be used in conjunction with other clinical and laboratory findings, such as AFC, before starting fertility therapy. This assay is not intended to be used for monitoring women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.

The ADVIA Centaur AMH assay is a sandwich immunoassay using direct acridinium ester-based chemiluminometric technology. Two monoclonal anti-AMH antibodies are employed in the assay. The first antibody in the Lite Reagent is a mouse monoclonal anti-AMH antibody labeled with acridinium ester. The second antibody is a biotinylated mouse monoclonal anti-AMH antibody coupled to streptavidin-coated magnetic particles in the Solid Phase. A direct relationship exists between the amount of AMH present in the patient sample and the amount of relative light units detected by the system. Dose concentration results (ng/mL) are calculated based on a 2-point calibration from a pre-defined master curve. Materials include: ADVIA Centaur AMH ReadyPack® primary reagent pack: Solid Phase (Streptavidin-coated paramagnetic microparticles with biotinylated mouse monoclonal anti-human AMH antibody in buffer; sodium azide (< 0.1%); blocker (bovine); surfactant; preservatives) ADVIA Centaur AMH ReadyPack® ancillary reagent pack: Ancillary Reagent (Mouse monoclonal anti-human AMH antibody labeled with acridinium ester in buffer (~0.6 µg/mL); sodium azide (<0.1%); blocker (bovine, murine); stabilizers; surfactant; preservatives) AMH CAL: After reconstitution, low and high levels of AMH antigen (bovine) in defibrinated human plasma; sodium azide (< 0.1%); preservatives

The Access AMH assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in the assessment of ovarian reserve in women presenting to fertility clinics. This system is intended to distinguish between women presenting with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve). The Access AMH is intended to be used in conjunction with other clinical and laboratory findings such as antral follicle count, before starting therapy. The Access AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.

The Access Anti-Mullerian Hormone Assay, Access Anti-Mullerian Hormone Calibrators, and the Access Immunoassay analyzers comprise the Dxl 9000 Access Immunoassay System for the quantitative determination of Anti-Mullerian Hormone levels in human serum and lithium heparin plasma using the Dxl 9000 Access Immunoassay system.

Elecsys AMH is intended for the in vitro quantitative determination of anti-Müllerian hormone (AMH) in human serum and lithium heparin plasma. The determination of AMH is used for the ovarian reserve in women presenting to fertility clinics. This immunoassay is intended to distinguish between women presenting with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve). This immunoassay is intended to be used for assessing the ovarian reserve in conjunction with other clinical and laboratory findings before starting any fertility therapy. Elecsys AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program. The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e immunoassay analyzers.

The Elecsys AMH immunoassay makes use of a sandwich test principle using a biotinylated monoclonal AMH-specific antibody and a monoclonal AMH-specific antibody labeled with a ruthenium complex. The Elecsys AMH immunoassay is intended for the quantitative determination of anti-Müllerian hormone (AMH) in human serum and lithium heparin plasma. It is 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-AMH-Ab~biotin (gray cap), 1 bottle, 8 mL: Biotinylated monoclonal anti-AMH antibody (mouse) 1.0 mg/L, phosphate buffer 50 mmol/L, pH 7.5; preservative. - Anti-AMH-Ab~Ru(bpy) (black cap), 1 bottle, 8 mL: Monoclonal anti-AMH antibody (mouse) labeled with ruthenium complex 1.0 mg/L, biotin scavenger antibody 1 mg/mL, phosphate buffer 50 mmol/L, pH 7.5; preservative.

The Access AMH assay is a paramagnetic particle chemiluminescent immunoassay for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and lithium heparin plasma using the Access Immunoassay Systems as an aid in the assessment of ovarian reserve in women presenting to fertility clinics. This system is intended to distinguish between women presenting with AFC (antral follicle count) values > 15 (high ovarian reserve) and women with AFC values ≤ 15 (normal or diminished ovarian reserve). The Access AMH is intended to be used in conjunction with other clinical and laboratory findings such as antral follicle count, before starting fertility therapy. The Access AMH is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program.

The Access AMH assay, Access AMH Calibrators, Access AMH QC, along with the Access 2 Immunoassay System analyzer comprise the Access Immunoassay System for the quantitative determination of anti-Müllerian hormone (AMH) levels in human serum and plasma.

Elecsys AMH system, consisting of the Elecsys AMH CalSet, PreciControl AMH, and AMH CalCheck 5, is intended for use in the in vitro quantitative determination of anti-Müllerian hormone (AMH) in human serum and lithium heparin plasma. The determination of AMH is used for the assessment of ovarian reserve in women presenting to fertility clinics. This system is intended to distinguish between women presenting with AFC (antral follicle count) values >15 (high ovarian reserve) and women with AFC values ≤15 (normal or diminished ovarian reserve). This system is intended to be used for assessing the ovarian reserve in conjunction with other clinical and laboratory findings before starting any fertility therapy. The Elecsys AMH system is not intended to be used for monitoring of women undergoing controlled ovarian stimulation in an Assisted Reproduction Technology program. The Elecsys AMH system is intended for use on cobas e 411 analyzer. AMH CalSet is used for calibrating the quantitative Elecsys AMH assay. PreciControl AMH is used for quality control of the Elecsys AMH assay. AMH CalCheck 5 is an assayed control for use in calibration verification and for use in the verification of the assay range established for the Elecsys AMH assay.

The Elecsys AMH reagent working solutions are packed in Rack Pack (kit placed on analyzer), which include: - Streptavidin-coated microparticles (transparent cap). 1 bottle. 6.5 mL: Streptavidin-. coated microparticles 0.72 mg/mL; preservative. - . Reagent 1: Anti-AMH-Ab~biotin (gray cap), 1 bottle, 8 mL: Biotinylated monoclonal anti-AMH antibody (mouse) 1.0 mg/L, phosphate buffer 50 mmol/L, pH 7.5: preservative. - Reagent 2: Anti-AMH-Ab~Ru(bpy)32+ (black cap), 1 bottle, 8 mL: Monoclonal . anti-AMH antibody (mouse) labeled with ruthenium complex 1.0 mg/L, phosphate buffer 50 mmol/L, pH 7.5; preservative. The AMH CalSet is a lyophilized equine serum matrix with endogenous AMH (Cal 1) and a lyophilized equine serum matrix with added bovine AMH (Cal 2). The CalSet includes: - AMH Cal 1: approximately 0.04 ng/mL endogenous AMH in an equine serum matrix, . preservative. - . AMH Cal 2: approximately 8 ng/mL bovine AMH in an equine serum matrix, preservative. PreciControl AMH is a lyophilized equine serum matrix with added bovine AMH (male fetal bovine serum) in two concentration ranges. The controls are used for monitoring the accuracy and precision of the Elecsys AMH assay. PreciControl AMH includes: - . PC AMH 1: approximately 1 ng/mL bovine AMH in an equine serum matrix, preservative. - PC AMH 2: approximately 5 ng/mL bovine AMH in an equine serum matrix, ● preservative. AMH CalCheck 5 is a (b) (4) (b) (4) (b) (4)