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UniCAP Specific IgE Assay is an in vitro semi-quantitative assay for the measurement of allergen Specific IgE in human serum or plasma. UniCAP Specific IgE assay is to be used with the instrument UniCAP 100. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.

Information Specific to Latex k82 Allergen

UniCAP Specific IgE Assay, Latex k82 test result may be used as an aid in the clinical diagnosis of patients with suspected latex allergy.

The allergen of interest, in this case Latex, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient serum specimen. After washing away non-specific IgE, enzyme labelled antibodies against IgE are added to form a complex. After incubation, unbound enzyme-anti-IgE is washed away and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the greater the quantity of specific IgE present in the specimen. To evaluate the test results, the response for the patient sample is compared directly to the response for the calibrators.

UniCAP 100 instrument with built in software processes all steps of the assay and prints results automatically after the assay is completed.

Here's a breakdown of the acceptance criteria and study information for the UniCAP Specific IgE, Latex Allergen ImmunoCAP k82, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a numerical or percentage threshold form. However, the study aims to demonstrate substantial equivalence to a predicate device and good clinical performance as measured by sensitivity, specificity, and overall agreement. For this type of submission, demonstrating comparable or better performance than the predicate is often the implicit acceptance criterion.

2. Sample Size for the Test Set and Data Provenance

• Sample Size for Test Set: 182 patients
  • 96 patients diagnosed as clinically allergic to latex with a positive latex skin test.
  • 86 patients clinically negative with a negative latex skin test.
• Data Provenance: The text states, "Serum samples from a total of 182 patients from three clinical sites were tested..." It does not specify the country of origin of these clinical sites. The data is retrospective in that it's using existing patient samples.

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

The ground truth was established by "clinical diagnosis as defined by clinical history and latex skin test (SPT) results." The document doesn't specify the number of experts involved in these clinical diagnoses nor their specific qualifications (e.g., "radiologist with 10 years of experience"). However, it generally implies that these diagnoses were made by qualified clinicians as part of standard medical practice at the "three clinical sites." The latex skin test is a well-established diagnostic tool.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (like 2+1 or 3+1) for establishing the clinical diagnosis, which served as the ground truth. It simply states the diagnosis was based on clinical history and latex skin test results. It does not mention any disagreement resolution process among multiple clinicians for individual patient diagnoses in this summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is an in-vitro diagnostic assay (an automated lab test), not an AI-powered diagnostic imaging or decision-support system that human readers would interact with.

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

Yes, this was a standalone performance study. The UniCAP Specific IgE FEIA Assay is an automated immunoassay system that provides a result (specific IgE levels for latex) directly. The reported performance metrics (sensitivity, specificity, overall agreement) reflect the algorithm/assay's performance in isolation, compared against the clinical diagnosis (ground truth). It is not designed to be used with a human-in-the-loop for result interpretation, beyond a clinician using the quantitative result to aid in diagnosis.

7. The Type of Ground Truth Used

The ground truth used was clinical diagnosis, defined by a combination of:

• Clinical history
• Latex skin test (SPT) results

8. The Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This type of submission for an immunoassay typically focuses on the performance of the finalized assay against a clinical reference standard rather than detailing the training of a machine learning algorithm. The "training" of such a system would involve the assay's development and optimization, but distinct "training sets" in the AI sense are not mentioned.

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

Since no distinct training set is mentioned in the context of an "AI training/ground truth" in this document, this question is not applicable to the provided information. The assay itself embodies the established chemical and biological principles for IgE detection.

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