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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.
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(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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(101 days)
The Epstein Barr Virus Viral Capsid Antigen (EBV-VCA) IgG ELISA Test is for the qualitative detection of IgG 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 IgG ELISA should be used in conjunction with other EBV serologies.
The EBV-VCA IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG antibodies to EBV-VCA antigen in human serum.
Acceptance Criteria and Device Performance for PANBIO EBV-VCA IgG ELISA Kit
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state pre-defined acceptance criteria values for the performance metrics (sensitivity, specificity, and agreement). However, it reports the calculated performance against the defined EBV status. For the purpose of this response, the reported performance values will be considered as effectively meeting the implicit criteria for substantial equivalence to a predicate device.
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Study Site 2, USA) | Reported Device Performance (Study Site 3, Australia) |
|---|---|---|---|
| Serological Sensitivity (Acute) | Sufficient to demonstrate equivalence | 69.2% (95% CI: 48.2 – 85.7%) | 92.9% (95% CI: 80.5 – 98.5%) |
| Serological Sensitivity (Past) | Sufficient to demonstrate equivalence | 94.1% (95% CI: 87.6 – 97.8%) | 89.3% (95% CI: 85.6 – 93.1%) |
| Serological Specificity (Negative) | Sufficient to demonstrate equivalence | 96.4% (95% CI: 81.6 – 99.9%) | 91.7% (95% CI: 80.0 – 97.7%) |
| Serological Agreement | Sufficient to demonstrate equivalence | 90.4% (95% CI: 84.6 – 94.5%) | 90.1% (95% CI: 86.4 – 93.0%) |
| Cross-Reactivity (Specificity) | 0% positive results for disease panel | 0/29 (100% true negative) | N/A (Not reported separately for this site) |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Study Site 2 (USA):
- Sample Size: 156 frozen retrospective sera.
- Data Provenance: Maryland, USA. The samples were retrospective, meaning they were collected in the past for other purposes (EBV testing) and then re-analyzed.
- Study Site 3 (Australia):
- Sample Size: 352 prospective sera.
- Data Provenance: Queensland, Australia. The samples were prospective, meaning they were collected specifically for this study.
- Cross-Reactivity Study (Study Site 5):
- Sample Size: 29 specimens.
- Data Provenance: Not explicitly stated for specific geography, but the study was conducted to establish analytical specificity for the EBV-VCA IgG ELISA Test.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not specify the number or qualifications of experts used to establish the "EBV status" of the sera in either Study Site 2 or Study Site 3. The ground truth (EBV Status) was determined using "EBV ELISA assays from an alternate manufacturer" and other EBV serologies (VCA IgM, EBNA IgG) to categorize samples as "Seronegative," "Acute Infectious Mononucleosis," or "Past Infection." This implies reliance on established laboratory diagnostic methods rather than individual expert adjudication of raw data.
4. Adjudication Method for the Test Set:
Not applicable in the traditional sense of human expert adjudication. The "EBV Status" (ground truth) was established through the results of other EBV ELISA assays and serological markers, not by human experts adjudicating the PANBIO device's results. The comparison was to an established diagnostic status determined by alternative, presumably validated, methods.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. Without AI Assistance:
This information is not applicable. The device described is an in vitro diagnostic ELISA kit for detecting antibodies in serum, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation or MRMC studies.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done:
Yes, the studies presented (Study Site 2 and Study Site 3) evaluate the standalone performance of the PANBIO EBV-VCA IgG ELISA kit. The results (sensitivity, specificity, agreement) are calculated solely based on the device's output compared to the established EBV status of the samples. There is no mention of human interpretation or involvement in the final classification of the device's results.
7. The Type of Ground Truth Used:
The ground truth used was expert consensus on serological markers/established diagnostic assays. For the sensitivity and specificity studies (Study Site 2 & 3), the "EBV Status" was determined by a combination of other EBV serological assays (VCA IgG, VCA IgM, EBNA IgG) from an alternate manufacturer. For the cross-reactivity study, the ground truth was "confirmed disease other than Epstein Barr Virus" as characterized prior to analysis.
8. The Sample Size for the Training Set:
The document does not explicitly state a separate "training set" size. For an ELISA kit, development often involves optimization and calibration using various samples, but these are typically not referred to as a "training set" in the same way as machine learning models. The provided studies focus on validation/test sets.
9. How the Ground Truth for the Training Set Was Established:
As there is no explicitly defined "training set" for the purpose of a machine learning model, the method for establishing its ground truth is not provided. The development and calibration of an ELISA kit involve establishing cutoff values and validating reagent performance, which would inherently rely on characterized samples but not a "training set" in the AI sense.
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(270 days)
For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Nuclear Antigen-1 (EBV-EBNA-1 IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-EBNA-1 IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM , Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgM, Early Antigen-Diffuse (EA-D) IgG and IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of paired sera, to determine a significant increase in EBNA-1 IgG antibody titer, can also aid in the diagnosis of acute infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated Processor.
The CEBV-EBNA-1 IgG ELISA Kit is an enzyme-linked inımunosorbent assay (ELISA) for the detection of IgG to Epstein Barr Nuclear antigen-1 in human serum.
Here's a breakdown of the acceptance criteria and study information for the ZEBV EBNA-1 IgG ELISA Kit, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" as a separate section with predefined targets. Instead, it presents the "Performance Characteristics" of the proposed device (Diamedix Is-EBV-EBNA IgG ELISA Kit) and compares them to a predicate device (Wampole EBNA-1 IgG ELISA). The implicit acceptance criteria are that the device performs comparably to or better than the predicate device.
Here's a table summarizing the reported performance, which serves as the fulfillment of these implicit criteria:
| Performance Characteristic | Proposed Device (Diamedix Is-EBV-EBNA IgG ELISA Kit) | Predicate Device (Wampole EBNA-1 IgG ELISA) |
|---|---|---|
| Relative Sensitivity | 98.0% | 97.8% |
| Relative Specificity (Current Infection) | 87.2% | (Not explicitly listed for current infection, but overall specificity is 100%) |
| Relative Specificity (Seronegative) | 97.1% | 100% (overall specificity) |
| Agreement | 95.4% | 98.3% |
| Intra-assay Precision (Manual) | 2.46-8.69% CV | (Not explicitly listed) |
| Intra-assay Precision (MAGO Plus) | 3.33-6.55% CV | (Not explicitly listed) |
| Interassay Precision (Manual) | 3.73-8.86% CV | 7.70-10.78% CV (Inter-Site Precision) |
| Interassay Precision (MAGO Plus) | 7.80-9.23% CV | (Not explicitly listed) |
| Cross-reactivity | No cross-reactivity with VZV, CMV, HSV | No cross-reactivity |
| Correlation (Manual vs. MAGO Plus) | Pearson Correlation Coefficient: 0.991 | Not Applicable (MAGO Plus compatibility is for the proposed device) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Sensitivity and Specificity Test Set: 175 sera
- 102 convalescent sera
- 34 seronegative sera
- 39 current (recent) infection sera
- Data Provenance: The document does not specify the country of origin. It indicates that the sera were from "one hundred and seventy-five patients" and were tested by an "independent clinical commercial laboratory." The study is retrospective, as the patient sera were "characterized using commercially available kits" prior to being tested with the proposed device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The ground truth for the test set was established by characterizing sera "using commercially available kits for VCA IgG, VCA IgM, EBNA IgG and heterophile antibodies." This implies that the ground truth was based on the results of established diagnostic assays, not direct expert interpretation of patient samples. Therefore, information about the number or qualifications of clinicians/experts interpreting these initial commercial kit results is not provided or directly relevant in the context of this study design.
4. Adjudication Method for the Test Set
There is no mention of an adjudication method in the context of establishing the ground truth or evaluating the test results. The categorization of sera (convalescent, seronegative, current infection) was based directly on the results of predicate commercial kits.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This device is an immunoassay kit for detecting antibodies, not an imaging or diagnostic device that involves human readers interpreting results. The comparison is between the proposed kit's performance and a predicate kit's performance, as well as the proposed kit's performance with manual vs. automated processing.
6. Standalone (Algorithm Only) Performance
Yes, the study primarily evaluates the standalone performance of the Diamedix Is-EBV-EBNA-1 IgG ELISA Kit itself. It's a laboratory diagnostic test kit, not an algorithm in the typical sense of AI. The performance characteristics (sensitivity, specificity, precision) are inherent to the kit's design and chemical reactions, whether performed manually or on an automated platform (MAGO Plus). The "algorithm" here refers to the immunoassay procedure and interpretation criteria.
7. Type of Ground Truth Used
The ground truth used was expert consensus derived from a panel of commercially available diagnostic kits. Specifically, sera were characterized using:
- VCA IgG (Viral Capsid Antigen IgG)
- VCA IgM (Viral Capsid Antigen IgM)
- EBNA IgG (Epstein-Barr Nuclear Antigen IgG)
- Heterophile antibodies
Based on results from these kits, sera were categorized into:
- Convalescent (past infection)
- Seronegative
- Current (recent) infection
8. Sample Size for the Training Set
The document describes a 510(k) submission for a diagnostic kit, not a machine learning model. Therefore, there is no explicit "training set" in the sense of data used to train an AI algorithm. The development of the kit (e.g., reagent formulation, optimization of conditions) would have involved internal R&D, but this document focuses on the validation of the finalized kit.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" for an AI model, this question is not applicable to this submission. The "ground truth" used in the performance validation study (clinical sensitivity and specificity) was established by characterizing patient sera with commercially available diagnostic kits, as described in point 7.
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(270 days)
For the qualitative and semi-quantitative determination of IgG antibodies to Epstein-Barr Virus (recombinant) Early Antigen Diffuse (EBV-EA-D IgG) in human serum by indirect enzyme immunoassay. The Is-EBV-EA-D IgG Test Kit may be used in combination with other Epstein-Barr serologies (Viral Capsid Antigen (VCA) IgG and IgM , Epstein-Barr Nuclear Antigen-1 (EBNA-1) IgG and IgM, Early Antigen-Diffuse (EA-D) IgM and heterophile antibody as an aid in the diagnosis of infectious mononucleosis (IM). The evaluation of paired sera, to determine a significant increase in EA-D IgG antibody titer, can also aid in the diagnosis of acute infection. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated Processor.
The Is-EBV-EA-D IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to Epstein Barr Early Antigen diffuse in human serum. Recombinant EA-D antigen is bound to microwells. Diluted patient sera, Cut-Off Calibrator and controls are placed in the microwells and incubated. Anti-EA-D IgG antibodies, if present, will bind to the antigen forming antigen-antibody complexes. Residual sample is eliminated by aspirating, Conjugate (horseradish peroxidase-labeled anti-human IgG) is added and will bind to these complexes. Unbound conjugate is removed by aspiration and washing. Substrate is then added and incubated. In the presence of bound enzyme the substrate is converted to an end product. The absorbance of this end product can be read spectrophotometrically at 450 nm (reference 600-630 nm) and is directly proportional to the concentration of IgG antibodies to EA-D present in the sample.
The provided document describes the "Is-EBV-EA-D IgG ELISA Kit" and its performance characteristics, primarily for establishing substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study findings based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria for the "Is-EBV-EA-D IgG ELISA Kit" to meet. Instead, it presents performance characteristics and concludes substantial equivalence based on a comparison with a predicate device. The values reported for the proposed device are presented as its performance, without explicit thresholds set beforehand as "acceptance criteria."
However, we can infer performance metrics that were evaluated:
| Performance Characteristic | Reported Device Performance (Is-EBV-EA-D IgG ELISA Kit) |
|---|---|
| Relative Sensitivity (Late Infection) | 81.8% |
| Relative Sensitivity (Current Infection) | 28.1% |
| Relative Specificity (Convalescent) | 89.7% |
| Relative Specificity (Seronegative) | 100.0% |
| Overall Agreement | 79.9% |
| Intra-assay Precision (Manual) | 2.07-13.88% CV (Positive samples, all sites collectively, range across samples) |
| Intra-assay Precision (MAGO Plus) | 1.77-18.00% CV (Positive samples, all sites collectively, range across samples) |
| Inter-assay Precision (Manual) | 5.12-9.08% CV (Positive samples, all sites collectively, range across samples) |
| Inter-assay Precision (MAGO Plus) | 5.09-11.61% CV (Positive samples, all sites collectively, range across samples) |
| Cross-reactivity | No cross-reactivity expected with Varicella Zoster, Cytomegalovirus, and Herpes Simplex Virus. (Tested with 16 sera, 15 anti-VZV IgG positive, 3 anti-CMV IgG positive, 3 anti-HSV positive, all non-reactive for anti-EA-D IgG) |
| Correlation (Manual vs. MAGO Plus) | Pearson Correlation Coefficient: 0.989 (Based on 193 serum samples) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 184 frozen retrospective sera for clinical sensitivity and specificity.
- Data Provenance: The sera were retrospectively collected and "characterized as research frozen retrospective sera." The document does not specify the country of origin, only stating it was tested by "an independent clinical commercial laboratory." It is retrospective data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify that "experts" were used to establish the ground truth in the traditional sense of a human review panel. Instead, the sera were "characterized" based on a combination of different EBV serologies.
- No explicit number of experts is mentioned.
- No qualifications of experts are provided.
4. Adjudication Method for the Test Set
There was no adjudication method described. The "ground truth" (EBV serological status) was established by characterizing the sera based on results from other EBV serologies (VCA IgG, VCA IgM, EBNA IgG, heterophile antibody), not through a human consensus or adjudication process for the test device itself.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This device is an in-vitro diagnostic (IVD) assay (ELISA), which measures biochemical markers and thus does not involve human readers interpreting images or data alongside an AI.
6. Standalone (Algorithm Only) Performance
Yes, the study primarily describes the standalone performance of the "Is-EBV-EA-D IgG ELISA Kit" as an in-vitro diagnostic test. There is no "human-in-the-loop" component described for interpreting the ELISA results themselves beyond the technician performing the test and reading the absorbance values to calculate an index value, which then falls into predefined interpretative ranges (negative, equivocal, positive). The "MAGO Plus Automated Processor" is mentioned as an automated way to run the assay, but it automates the physical assay steps, not interpretive steps.
7. Type of Ground Truth Used
The ground truth used was EBV Serological Status, established by testing the sera with a panel of other established EBV serologies (VCA IgG, VCA IgM, EBNA IgG, heterophile antibody). This is a form of reference standard data based on established diagnostic tests for Epstein-Barr Virus infection. It is not pathology, expert consensus on the device's output, or outcomes data.
8. Sample Size for the Training Set
The document does not describe a "training set" in the context of an algorithm or machine learning device. This is an ELISA kit, a traditional biochemical assay. Therefore, there is no explicit training set as would be found in AI/ML device development. The assay's parameters would have been developed and optimized internally by the manufacturer, but this is not typically referred to as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
As there is no described training set for an algorithm, the concept of establishing ground truth for a training set does not apply directly. The development of the ELISA kit itself relies on established serological principles and reagents (e.g., recombinant EA-D antigen), with internal validation studies conducted during development to optimize its performance, but this is distinct from establishing ground truth for an AI/ML training set.
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