(29 days)
Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma. The test aids in the diagnosis of infectious mononucleosis.
Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma.
This document describes the acceptance criteria and study proving the performance of the Color-Monogen device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Sensitivity | |
| Relative to a commercially available horse red cell slide test. (No specific threshold given, but implied to be high for a diagnostic test). | 97.9% (95% Confidence Interval = 88.7 - 99.9%) |
| Specificity | |
| Relative to a commercially available horse red cell slide test. (No specific threshold given, but implied to be high for a diagnostic test). | 95.8% (95% Confidence Interval = 91.9-98.2%) |
| Reproducibility (Qualitative & Semiquantitative) | |
| 100% reproducibility when accepting an error on repeated estimations of only one two-fold dilution for semiquantitative procedure, and for qualitative procedure using kit controls. | 100% (Qualitative and Semiquantitative) |
2. Sample Sizes and Data Provenance
- Test Set Sample Sizes:
- Sensitivity: 48 samples (presumptively positive for IM heterophile antibodies)
- Specificity: 200 samples (randomly selected serum patient samples presumptively negative for IM heterophile antibodies)
- Reproducibility: An in-house IM heterophile antibody calibrator diluted from 1/1 to 1/32, plus Color-Monogen kit controls (negative and positive). The exact number of individual "samples" for reproducibility testing beyond the calibrator dilutions and controls isn't specified, but it was tested by three operators on five consecutive days.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "samples" and "serum patient samples."
3. Number of Experts and Qualifications for Ground Truth
- The study design does not indicate the use of experts to establish ground truth for the test set. Instead, it uses a commercially available horse red cell slide test as the reference method for comparison to determine sensitivity and specificity.
4. Adjudication Method
- No adjudication method (e.g., 2+1, 3+1, none) for the test set is described, as the ground truth was established by comparison to a predicate device, not by expert consensus.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- A MRMC comparative effectiveness study was not conducted. The study focuses on the device's performance against a predicate device, not on human reader performance with or without AI assistance.
- For reproducibility, three different operators tested the samples for 5 consecutive days, but this was to assess the device's consistency, not to compare human reader performance with or without AI.
6. Standalone Performance Study
- Yes, a standalone performance study was done. The reported sensitivity, specificity, and reproducibility figures represent the Color-Monogen device's performance directly, independent of human interpretation or assistance beyond following the test procedure.
7. Type of Ground Truth Used
- The ground truth for sensitivity and specificity was established by comparing the Color-Monogen device's results to a commercially available horse red cell slide test. For reproducibility, an in-house IM heterophile antibody calibrator and Color-Monogen kit controls served as the reference.
8. Sample Size for the Training Set
- No information is provided about a training set. This device is a diagnostic test kit (direct hemagglutination) and likely does not involve machine learning or an algorithm that requires a separate training set.
9. How Ground Truth for Training Set Was Established
- Not applicable, as no training set is mentioned or implied for this type of device.
§ 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).