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Allergen ImmunoCAPTM is the solid phase component of the Pharmacia & Upjohn in vitro immunodiagnostic systems which measure specific IgE to the respective allergen bound to the ImmunoCAP™. Allergen ImmunoCAP™ are intended to be used with Pharmacia CAP System™ RAST FEIA and UniCAP® Specific IgE in vitro diagnostic assays.

Pharmacia CAP System RAST® FEIA and UniCAP® Specific IgE are intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and are to be used in clinical laboratories, as well as, physician office laboratories.

Allergen ImmunoCAP™ consists of a cellulose sponge matrix to which allergenic components are covalently coupled. The matrix is encased in a small round plastic capsule. This capsule is at the same time a holder of the matrix for convenient automation and a reaction chamber.

The sponge matrix is manufactured from activated cellulose derivative to which allergen extract solution is added under defined optimized conditions for the allergen coupling. This solid phase is an excellent carrier of allergens and provides favorable reaction conditions.

Here's a breakdown of the acceptance criteria and the study information for the Allergen ImmunoCAP™ device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it describes a functional verification process:

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "clinical serum samples, with a history or indication of allergy to the specific allergen, and established negative samples." The exact number of samples for each allergen or overall is not provided.
• Data Provenance: Not explicitly stated. Given that the manufacturer is Pharmacia & Upjohn, Diagnostics AB in Uppsala, Sweden, and the US operation is in Kalamazoo, MI, it is likely that samples came from either or both regions, but this is not confirmed. The study appears to be retrospective, as it uses "clinical serum samples" and "established negative samples," implying samples collected prior to the study.

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

• Number of Experts: Not specified.
• Qualifications of Experts: The document states that the samples were "clinical serum samples, with a history or indication of allergy to the specific allergen, and established negative samples." This implies that the ground truth (positive or negative for allergy) was established by clinical diagnosis or history, likely by medical professionals (e.g., allergists, physicians) based on patient symptoms, history, and potentially other diagnostic tests, but the specific role and qualifications of experts in establishing this ground truth for the study are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. The document states that "results show an outstanding agreement of outcome concerning positive and negative samples" between the two test systems, but it doesn't describe a process for resolving discrepancies or establishing a definitive ground truth through adjudication for the study. The ground truth appears to be pre-established clinical history.

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

• MRMC Study: No, this was not an MRMC comparative effectiveness study in the typical sense of evaluating human readers with and without AI assistance. This device is an in-vitro diagnostic (IVD) test system (ImmunoCAP™) that measures specific IgE antibodies, not an AI-driven image analysis or diagnostic aid for human readers. The study compares the performance of the new ImmunoCAP™ allergens within two existing automated test systems (Pharmacia CAP System™ and UniCAP™).

6. Standalone Performance (Algorithm Only)

• Standalone Performance: Yes, in a way. The "device" is the Allergen ImmunoCAP™ itself, which is a component of an automated laboratory test. The performance characteristics described are for the ImmunoCAP™'s ability to bind specific IgE and yield accurate positive/negative results when run on the automated systems. There is no "human-in-the-loop" performance to consider for this type of diagnostic test. The study evaluates the performance of the ImmunoCAP™ as a standalone component within the larger automated diagnostic process.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the test set was based on clinical history or indication of allergy for positive samples and "established negative samples." This is essentially a form of clinical diagnosis/history.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes the safety and effectiveness of physically manufactured in-vitro diagnostic components (ImmunoCAPs) that are chemically coupled with allergens. There is no "algorithm" or machine learning model that requires a training set in the conventional sense. The "training" for such components involves optimization during manufacturing (e.g., allergen coupling conditions) and quality control, not data-driven model training.

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

• How Ground Truth for Training Set was Established: Not applicable, as there is no training set for an algorithm. The development and optimization of the ImmunoCAP™ manufacturing process (e.g., allergen coupling) would rely on analytical performance characteristics (e.g., binding efficiency, signal-to-noise ratio) and iterative testing, rather than a "ground truth" derived from patient data in a training set context.

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