Search Results

The Centocor CA 15-3 RIA is an in vitro test for the quantitative determination of DF3 antibodydefined antigen, encoded by the MUC 1 gene, in serum and plasma, Serial test results obtained with the Centocor CA 15-3 RIA, are useful in the early detection of recurrence in patients previously treated for stage III breast cancer, who are clinically free of disease. Early detection of recurrence cannot be readily accomplished by routine clinical or diagnostic studies alone. The use of a circulating serum tumor marker assay, such as Centocor CA 15-3 RIA, can be useful in the identification of these patients. The Centocor CA 15-3 RIA should be used in conjunction with all relevant information derived from diagnostic tests, physical examination and full medical history, in accordance with appropriate patient management procedures

The Centocor CA 15-3 RIA is an in vitro diagnostic device based on the well established RIA "forward sandwich" principle. The device is in kit format and consists of murine monoclonal antibody 115D8-coated polystyrene beads, standards, diluent, positive control, and 122 radio-labeled, murine monoclonal antibody, DF3. Antibody coated beads are incubated with a specimen or the appropriate standards and controls. During this initial incubation step, DF3 antibody-defined antigen present in the specimen are bound by the coated beads. Unbound material present in the specimen are removed by aspiration and washing. In the second step, the beads are incubated with DF3 radio-labeled with "2". The tracer detects DF3 antibody-defined antigen bound to the beads during the initial incubation step. The unbound tracer antibody is removed by washing and aspiration. The bound radioactivity is determined by counting the beads in a gamma counter. The bound radioactivity is directly proportional to the concentration of the DF3 antibody-defined antigen in the specimen. A standard curve is obtained by plotting the DF3 antibody-defined antigen concentration of the standards against the bound radioactivity.

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are established by comparing the Centocor CA 15-3 RIA to a predicate device, the Biomira TRUQUANT BR RIA. The key metric for this comparison is linear agreement and precision.

Note: The document explicitly states "The Centocor CA 15-3 RIA and the TRUQUANT BR RIA demonstrated good linear agreement and precision comparable to that claimed in the TRUQUANT BR RIA product instructions." The exact numerical acceptance thresholds for "good linear agreement" and "comparable precision" are not explicitly stated, but the reported performance values met this unspecified standard.

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

• Sample Size for Linear Agreement Study: 204 serum samples

• Data Provenance: Not explicitly stated regarding the country of origin. The study appears to be a retrospective analysis of collected serum samples from breast cancer patients.

• Sample Size for Inter and Intra-Assay Precision Study: 24 coded samples (2 sets of 12 samples) and 1 kit control. Tested repeatedly.

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

This information is not provided in the document. The study compares two diagnostic assays against each other rather than validating against a clinical ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not provided. The study is a direct comparison between two assays, not a study involving expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement with AI vs. Without AI Assistance

This information is not applicable/provided. The device is an in-vitro diagnostic assay, not an AI-assisted diagnostic tool that would involve human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance data presented is for the Centocor CA 15-3 RIA device itself, which is an in-vitro diagnostic test. Therefore, the "standalone" performance is what is described. It measures the assay's analytical performance in terms of linearity and precision.

7. The Type of Ground Truth Used

The "ground truth" for the comparative study was the results obtained from the predicate device (Biomira TRUQUANT BR RIA). The Centocor CA 15-3 RIA's performance was evaluated for its agreement with this established method. For the precision studies, the ground truth was the expected value of the control samples.

8. The Sample Size for the Training Set

This information is not provided. The document describes a comparison study and assay validation, not the development or training of an algorithm in the machine learning sense. The assay works based on a biochemical principle, not a trained model.

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

This information is not applicable/provided. As noted above, the device is an in-vitro diagnostic assay based on a biochemical principle, not a machine learning model that would require a "training set" with established ground truth in that context.

Ask a specific question about this device

Ask a specific question about this device