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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:

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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The . Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.

Epstein-Barr Early Antigen Diffuse component (EA-D) IgG kit is an Enzyme-Linked The Immunosorbent Assay (ELISA) for the qualitative determination of IgG antibodies in human serum to EA-D antigen. The Clark anti-EA-D IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EBNA-1 IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. The EA-D IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Epstein-Barr Early Antigen Diffuse component. Purified recombinant EA-D antigen is attached to a solid phase microtiter well. Diluted test sera is added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. If antibody is present it will bind to the antibody attached to the antigen on the well. After incubation the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing an indirect measurement of specific antibody in the patient specimen.

Here's an analysis of the provided text to extract the acceptance criteria and study information:

Acceptance Criteria and Device Performance for EA-D IgG ELISA Test Kit

1. Table of Acceptance Criteria and Reported Device Performance

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