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510(k) Data Aggregation
(101 days)
The Epstein Barr Virus Nuclear Antigen (EBNA) IgG ELISA Test is for the qualitative detection of IgG antibodies to EBNA in serum as an aid in the clinical laboratory diagnosis of Epstein barr virus (EBV) infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBNA IgG ELISA should be used in conjunction with other EBV serologies.
The EBV-EBNA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV-EBNA antigen in human serum.
Here's a breakdown of the acceptance criteria and study information for the PANBIO EBV-EBNA IgG ELISA Kit:
Acceptance Criteria and Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided document. However, the study results demonstrate that the device performs with high serological sensitivity and specificity, the implied acceptance criteria were likely based on these performance metrics being sufficiently high and comparable to the predicate device. The reproducibility data also indicates consistent performance, which would be an implicit acceptance criterion.
| Performance Metric | Study Site 2 (Retrospective, USA) - Reported Performance | Study Site 3 (Prospective, Australia) - Reported Performance |
|---|---|---|
| Serological Sensitivity (Past EBV) | 97.1 (95% CI: 91.6 - 99.4%) | 85.1% (95% CI: 80.8 - 89.4%) |
| Serological Specificity (Acute IM) | 92.3% (95% CI: 74.9 - 99.1%) | 100.0% (95% CI: 91.6 - 100.0%) |
| Serological Specificity (Seronegative) | 96.4% (95% CI: 81.6 - 99.9%) | 100.0% (95% CI: 92.6 - 100.0%) |
| Serological Agreement | 96.2% (95% CI: 91.8 - 98.6%) | 88.9% (95% CI: 85.6 - 92.2%) |
| Cross-Reactivity (vs. 32 other diseases) | 0/32 positive (100% negative) | Not applicable (tested for analytical specificity) |
| Reproducibility (CV%) | Various CVs reported for different samples (e.g., 4.7% - 28.8% for total precision) | Same reproducibility study across 3 sites (see table for details) |
Study Information
Test Set and Data Provenance:
- Study Site 2:
- Sample Size: 156 frozen sera.
- Data Provenance: Retrospective, collected from a state health laboratory in Maryland, USA.
- Study Site 3:
- Sample Size: 352 sera.
- Data Provenance: Prospective, collected from a private pathology laboratory in Queensland, Australia.
Number of Experts and Qualifications for Ground Truth:
- The document does not explicitly state the number of experts or their qualifications for establishing the ground truth.
- Instead, the ground truth (EBV status) for the test sets was established by using "EBV ELISA assays from an alternate manufacturer" and other serological markers (VCA IgG, VCA IgM, EBNA IgG) to categorize samples into Seronegative, Acute Infectious Mononucleosis, and Past Infection groups. This implies that the 'experts' in this context are well-established diagnostic assays and the interpretation of their results by laboratory personnel.
Adjudication Method:
- No explicit adjudication method (e.g., 2+1, 3+1) is mentioned.
- The ground truth was determined by the results of established EBV serological assays from an alternate manufacturer, used as a reference standard. Equivocal samples in Study Site 2 were not retested due to unavailability, and in Study Site 3, due to insufficient sample.
MRMC (Multi-Reader Multi-Case) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not performed. This device is an in vitro diagnostic assay, not an AI-assisted diagnostic tool that aids human interpretation of images or other complex data.
Standalone (Algorithm Only) Performance:
- Yes, the studies directly assess the standalone performance of the PANBIO EBV-EBNA IgG ELISA Kit. The reported sensitivity, specificity, and agreement are measures of the algorithm's (the ELISA kit's) performance compared to the established serological EBV status. There is no human-in-the-loop component in these performance evaluations.
Type of Ground Truth Used:
- The ground truth used was expert consensus serology, meaning the classification of samples into "Seronegative," "Acute Infectious Mononucleosis," or "Past Infection" based on multiple established EBV serological markers (VCA IgG, VCA IgM, EBNA IgG) from an alternate manufacturer. It is not pathology, nor direct outcomes data (though the categories correlate with disease state).
Training Set Sample Size:
- The document does not explicitly mention a training set or its sample size for the development of the EBV-EBNA IgG ELISA kit. This is typical for an ELISA kit, where the "training" involves optimizing the assay components and parameters rather than training a machine learning algorithm on a specific dataset. The studies described are performance validation studies.
How Ground Truth for Training Set was Established:
- As no explicit training set is mentioned in the context of machine learning, this question isn't directly applicable. The "ground truth" for the development of such an assay would involve internal quality controls, reference panels, and extensive optimization to ensure the assay reagents and conditions accurately detect the target antibody.
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