Search Results
Found 1 results
510(k) Data Aggregation
(100 days)
The Epstein-Barr Viral Capsid Antigen (VCA) IgM ELISA Test is for the qualitative detection of IgM antibodies to EBV VCA in serum as an aid in the clinical laboratory diagnosis of EBV infection in patients with clinical symptoms consistent with infectious mononucleosis (IM). The PANBIO EBV VCA IgM ELISA should be used in conjunction with other EBV serology.
The EBV-VCA IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to EBV-VCA antigen in human serum.
Here's a breakdown of the acceptance criteria and the study information for the EBV-VCA IgM ELISA Kit, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" as a separate section with predefined thresholds. However, based on the performance data presented, the implied criteria are high sensitivity, specificity, and agreement compared to established EBV serological tests.
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance (Study Site 2 - Retrospective) | Reported Device Performance (Study Site 3 - Prospective) |
|---|---|---|---|
| Serological Sensitivity (Acute) | High | 100% (95% CI: 86.8 – 100 %) | 85.7% (95% CI: 71.5 - 94.6%) |
| Serological Specificity (Past) | High | 90.2% (95% CI: 82.7 – 95.2 %) | 98.1% (95% CI: 95.6-99.4%) |
| Serological Specificity (Negative) | High | 100% (95% CI: 87.7 – 100 %) | 87.5% (95% CI: 74.7 - 95.3%) |
| Serological Agreement | High | 93.6% (95% CI: 88.5 – 96.9 %) | 95.2% (95% CI: 92.4 - 97.2%) |
| Cross-Reactivity (Analytical Specificity) | 0% positive results for non-EBV diseases | 0% (0/50 specimens) | N/A (Only conducted once) |
2. Sample Sizes and Data Provenance for Test Sets:
- Study Site 2 (Retrospective Data):
- Sample Size: 156 frozen retrospective sera.
- Data Provenance: Maryland, USA. The samples include:
- 28 seronegative samples
- 26 samples from patients with acute Infectious Mononucleosis
- 102 samples from patients with past exposure to EBV
- Study Site 3 (Prospective Data):
- Sample Size: 352 prospective sera.
- Data Provenance: Queensland, Australia (private pathology laboratory). The samples include:
- 48 seronegative samples
- 42 samples from patients with acute Infectious Mononucleosis
- 262 samples from patients with past exposure to EBV
- Study Site 5 (Cross-Reactivity Data):
- Sample Size: 50 specimens from patients with confirmed diseases other than Epstein-Barr Virus.
- Data Provenance: Not specified, but generally collected for "potential cross-reactivity" and characterized prior to analysis.
3. Number of Experts and Qualifications for Ground Truth:
The document does not specify the number of experts used or their qualifications for establishing the ground truth. It states that the EBV status of the sera was determined "using EBV ELISA assays from an alternate manufacturer." This implies that the ground truth was established by comparing to existing, established serological methods, not necessarily by individual expert review of each case.
4. Adjudication Method for the Test Set:
The document does not describe an adjudication method (e.g., 2+1, 3+1). The ground truth for the test sets was established by comparison to the results of "EBV ELISA assays from an alternate manufacturer" to determine the EBV status.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic (IVD) ELISA kit, which is typically evaluated for its analytical and clinical performance against a reference method, not for human reader improvement with AI assistance.
6. Standalone (Algorithm Only) Performance:
Yes, the performance characteristics provided (sensitivity, specificity, agreement) are indicative of the standalone performance of the PANBIO EBV-VCA IgM ELISA kit. There is no human-in-the-loop component described for these performance evaluations.
7. Type of Ground Truth Used:
The ground truth used was expert consensus serology based on a panel of "EBV ELISA assays from an alternate manufacturer." The document states:
- "The EBV status of the sera" was determined using alternate manufacturer's assays.
- "Serological" sensitivity and specificity refers to the comparison of the PANBIO assay results to other assays normally used to diagnose EBV associated IM.
- It explicitly notes: "There was not an attempt to correlate the assay's results with disease presence or absence. No judgement can be made on the comparison's accuracy to predict disease." This clarifies that the ground truth is based on established serological markers of EBV infection status (e.g., VCA IgG/IgM, EBNA IgG), rather than direct pathology or outcomes data for the individuals.
8. Sample Size for the Training Set:
The document does not mention a training set or any deep learning/machine learning model that would require one. The EBV-VCA IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA), which is a biochemical assay, not a software algorithm that is "trained."
9. How Ground Truth for the Training Set Was Established:
Since there is no training set described for this ELISA kit, this question is not applicable.
Ask a specific question about this device
Page 1 of 1