Search Results

The Nichols Advantage® Chemiluminescence Helicobacter pylori IgG Antibodies Immunoassay is intended for use with the Nichols Advantage® Specialty System for the qualitative determination of anti-H. pylori IgG in human serum to aid in the diagnosis of infection by H. pylori.

The Nichols Advantage® Helicobacter pylori IgG Antibodies Assay is a two-site chemiluminescence assay for use with the Nichols Advantage® Specialty System. Nichols Institute Diagnostics utilizes chemiluminescence acridinium esters as the label in its specialty chemiluminescence system. Acridinium esters emit light upon treatment with hydrogen peroxide and an alkaline solution. The Trigger 1 solution contains hydrogen peroxide in diluted acid and Trigger 2 solution contains diluted sodium hydroxide. The system automatically injects Trigger solutions 1 and 2 into the wells of the cuvette which oxidize the acridinium ester. The oxidized product is in an excited state. The subsequent return to ground state results in the emission of light, which is quantified in two seconds and is expressed in relative light units (RLU) by the integrated system luminometer. The Nichols Advantage® Anti-H. pylori IgG Assay is a two-site chemiluminescence immunoassay for the measurement of anti-H. pylori IgG in human serum. It utilizes an acridinium-ester-labeled mouse monoclonal anti-human IgG antibody and a biotinylated H. pylori antigen cocktail. The sample containing anti-H. pylori IgG antibodies is incubated with the biotinylated antigen cocktail and magnetic particles for 10 minutes at 37°C. Free, unbound biotinylated antigens and anti-H. pylori IgG antibodies are separated from the complex bound to the magnetic particles by aspiration of the reaction mixture and subsequent washing. Thereafter, acridinium-labeled anti-human IgG antibodies are added to the reaction mixture and a second 10 minute incubation follows creating the sandwich complex. Free, unbound acridinium-labeled anti-human IgG antibodies are separated from the complex bound to the magnetic particles by aspiration of the reaction mixture and subsequent washing. The wells containing the washed magnetic particles are transported into the system luminometer, which automatically injects Trigger 1 and Trigger 2, initiating the chemiluminescence reaction. The light is quantitated by the luminometer and expressed as RLU. The amount of bound-labeled antibody is directly proportional to the titer of anti-H. pylori IgG antibodies in the sample. The Nichols Advantage Specialty System automatically handles sample dilution as well as sample and reagent additions, the temperature-controlled incubation, separation/washing step, and measurement of the light output. It calculates test results for controls and patient samples from the stored calibration curve, and generates a printed report, which includes patient information.

Here's an analysis of the provided text, extracting the requested information about acceptance criteria and the supporting study:

Acceptance Criteria and Device Performance for Nichols Advantage® H. pylori IgG Antibodies Immunoassay

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" with numerical thresholds for performance metrics. Instead, it presents performance characteristics and compares them to the predicate device, implying that the Nichols Advantage® assay's performance is considered acceptable if its characteristics are comparable or superior and meet the intended use.

Based on the "Performance Characteristics" section, here are the reported performance details:

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the "Method Comparison" test set, nor does it specify the country of origin of the data or whether the study was retrospective or prospective. It only presents the "Range of Results" for the method comparison as "1:13 to 1:5526" for the Nichols Advantage® assay and "1:97 to 1:9504" for the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not describe the use of experts to establish ground truth for the method comparison. The comparison is between the Nichols Advantage® assay and a predicate device (Orion Diagnostica Pyloriset® EIA-G Immunoassay), suggesting the predicate device's results served as a reference.

4. Adjudication Method for the Test Set

No adjudication method is described, as the comparison is primarily assay-to-assay.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was conducted or mentioned in the document. This is an in vitro diagnostic device, and MRMC studies are typically for imaging or interpretation tasks where human readers are involved.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

The device itself is an automated immunoassay system. The performance characteristics described for the Nichols Advantage® system are inherently standalone (algorithm/device only) without human-in-the-loop performance influencing the assay's raw output. The system automatically handles processes and calculates results.

7. Type of Ground Truth Used

The ground truth for the method comparison study appears to be the results obtained from the predicate device, the Orion Diagnostica Pyloriset® EIA-G Immunoassay. The document states a "Method Comparison" was performed, and then provides "Concordance," "Percent Agreement Positive," and "Percent Agreement Negative" between the new device and the predicate. This implies the predicate's results were used as a reference for comparison.

8. Sample Size for the Training Set

The document describes an immunoassay, not a machine learning algorithm that typically has a "training set." Therefore, a "training set" in the context of data used to train an algorithm is not applicable here. The assay relies on established chemical and immunological principles, with performance validated through analytical and clinical studies.

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

As noted above, a "training set" for an algorithm is not applicable for this type of device. The assay's analytical performance (intra-assay, inter-assay, recovery, parallelism) would have been established using characterized samples with known concentrations/titer ranges, but this is part of analytical validation, not algorithm training.

Ask a specific question about this device