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BGM Galectin-3 is an in vitro diagnostic device that quantitatively measures galectin-3 in serum or EDTA-plasma by enzyme-linked immunosorbant assay (ELISA) on a microtiter plate platform to be used in conjunction with clinical evaluation as an aid in assessing prognosis of patients diagnosed with chronic heart failure (HF). BGM Galectin-3 is indicated for prescription use only.

BGM Galectin-3 is a microtiter plate-based sandwich enzyme-linked immunosorbant assay (ELISA) for the quantitative determination of galectin-3 levels in human serum and plasma. BGM Galectin-3 consists of a rat monoclonal anti-mouse galectin-3 antibody coated microtiter plate serving as the solid phase capture antibody and a horseradish peroxidase (HRP)-labeled mouse monoclonal anti-human galectin-3 antibody functioning as the liquid phase tracer antibody for detecting bound galectin-3.

In the testing procedure, galectin-3 in the standard, control, or patient specimen binds to the immobilized capture antibody; after a wash step, bound galectin-3 is detected by the addition of HRP-labeled anti-galectin-3 antibody. Following a second wash step, the presence of bound galectin-3 is demonstrated by an enzymatic blue color development resulting from the addition of tetramethylbenzidene (TMB) solution as the substrate. Color development is stopped by adding sulfuric acid, changing the color to yellow. Color intensity is read at an absorbance of 450 nm using a colorimetric reader. The absorbance is proportional to the galectin-3 levels in the samples, and test results of the samples are determined using a calibration curve derived from the standards.

BGM Galectin-3 contains the microtiter plate, reagents, assayed quality control materials and standards required to perform analyses on serum or EDTA-plasma samples.

This document describes the analytical and clinical performance of the BGM Galectin-3™ assay.

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for all tests in a single table, but the "Summary of Performance Data" section describes various tests and their outcomes. For clinical performance, the focus is on hazard ratios and cumulative probabilities.

Here's an integrated table derived from the provided text, using reported outcomes as evidence of meeting implicit acceptance criteria:

• All-cause mortality & hospitalization: 1.35-1.46 (p=0.004-0.006)
• Cardiovascular mortality: 1.91-2.33 (p=0.002- 25.9 ng/mL).

These two sets effectively serve as the "training" or "derivation" sets for the clinical interpretation of the assay.

9. How the Ground Truth for the Training Set Was Established:

• Reference Range: Established from 1,099 apparently healthy subjects. "Healthy" implies the absence of known heart disease. The exact methods for confirming "healthy" status are not detailed but would typically involve medical history, physical examination, and possibly other diagnostic tests.
• Cutoff Value Derivation: Derived from 582 individuals with HF. The document implies these cutoffs were determined by analyzing the association between galectin-3 levels and adverse outcomes within this derivation cohort. The specific methodology for deriving these cutoffs (e.g., statistical methods like ROC curve analysis or survival analysis) is not explicitly detailed in this summary, but they are subsequently validated in a separate, larger cohort. "HF" diagnosis would be established by clinical criteria, but the specific validation method for that diagnosis is not given.

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For in vitro diagnostic use in the quantitative determination of Btype Natriuretic Peptide (BNP) in human plasma using the ADVIA Centaur® System. This assay is indicated for the measurement of plasma BNP as an aid in the diagnosis of heart failure. This assay is not intended for use on any other system.

The ADVIA® Centaur® BNP assay is a fully automated two-site sandwich immunoassay using direct chemiluminescent technology, which uses constant amounts of two monoclonal antibodies. The first antibody, in the Lite Reagent, is an acridinium ester labeled monoclonal mouse anti-human BNP F(ab')> fragment specific to the ring structure of BNP. The second antibody, in the Solid Phase, is a biotinylated monoclonal mouse anti-human antibody specific to the C-terminal portion of BNP, which is coupled to streptavidin magnetic particles. Patient sample (calibrator or control materials) is incubated for 5 minutes at 37°C with the Lite Reagent that contains the tracer antibody conjugate. Subsequently, Solid Phase reagent is added and incubated for 2.5 minutes at 37°C. An immuno-complex is formed between the BNP in the sample and the two antibody conjugates. Following incubation, the unbound antibody conjugates are washed away. The chemiluminescence of the immuno-complex signal is measured in a luminometer. Samples with low BNP levels will have a minimum amount of bound AE label, while samples with high levels of BNP will have maximum label complex bound. Thus, a direct relationship exists between the amount of BNP present in the patient sample and the amount of relative light units (RLUs) detected by the system.

The Bayer Diagnostics ADVIA Centaur BNP Assay is an in vitro immunoassay designed for the quantitative determination of B-type Natriuretic Peptide (BNP) in human plasma, to be used as an aid in the diagnosis of heart failure.

1. A table of acceptance criteria and the reported device performance

The provided text describes comparative performance against a predicate device and clinical agreement, rather than explicit pre-defined acceptance criteria with pass/fail thresholds. However, based on the comparative effectiveness study, we can infer the desired performance characteristics.

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