(179 days)
The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician's office laboratory and the clinical laboratory.
Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen using mouse monoclonal anti-IgM antibodies and heterophile antigen from bovine red blood cells.
Here's an analysis of the provided text regarding the Genzyme Diagnostics Contrast® Mono test, structured according to your request:
1. Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Overall Agreement | High agreement with predicate device (not explicitly stated as a numerical threshold, but implied by the comparison to a legally marketed predicate) | 99.2% agreement with Quidel Concise® Plus™ Mono |
| Reproducibility | Reproducible results across different days and users (not explicitly stated as a numerical threshold) | Demonstrated reproducible results at three physician's office laboratories |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 480 specimens (serum, plasma, and whole blood)
- Data Provenance: Retrospective (specimens submitted for infectious mononucleosis testing) and prospective (students presenting with symptoms) from a multicenter clinical study. The study was conducted in three physician's office laboratories (POLs), including two university student health centers and one clinical laboratory. The country of origin is not explicitly stated.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text states that the Genzyme device was compared to the "reference method" and the legally marketed "Quidel Concise® Plus™ Mono Test." The predicate device likely served as the de facto "ground truth" or a strong proxy for it. There is no information provided about the number of experts or their qualifications used to establish this reference method or to adjudicate the results of the Quidel test itself for the purpose of this study.
4. Adjudication Method for the Test Set
The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "reference method" or the predicate device's results were used for comparison. It's implied that the results of these reference methods were taken as authoritative.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported. The study focused on the agreement of the novel device with a predicate device, not on how human readers' performance improved with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone performance study. The Genzyme Diagnostics Contrast® Mono Test is a rapid immunoassay kit. Its performance was evaluated by comparing its direct results to those of a reference method/predicate device. There is no "human-in-the-loop" aspect to the device's output itself.
7. The Type of Ground Truth Used
The ground truth was established by comparing the test device's results to a legally marketed predicate device (Quidel Concise® Plus™ Mono Test) and a "reference method." While the nature of the "reference method" isn't explicitly detailed, in the context of IVD devices like this, it typically refers to a well-established and accepted diagnostic procedure for the disease.
8. The Sample Size for the Training Set
This information is not provided. The document describes a clinical study to evaluate the device's performance, but it does not detail any separate training set or process for developing the immunoassay itself.
9. How the Ground Truth for the Training Set Was Established
This information is not provided, as details about a specific "training set" for the device's development are absent from the document. The immunoassay itself would have been developed based on scientific principles and internal validation, but the documentation focuses on the external clinical validation study.
§ 866.5640 Infectious mononucleosis immunological test system.
(a)
Identification. An infectious mononucleosis immunological test system is a device that consists of the reagents used to measure by immunochemical techniques heterophile antibodies frequently associated with infectious mononucleosis in serum, plasma, and other body fluids. Measurements of these antibodies aid in the diagnosis of infectious mononucleosis.(b)
Classification. Class II (performance standards).