Search Results

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:

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.

Ask a specific question about this device