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ImmunoWELL VCA IgM Test is for the qualitative detection of IgM antibody to Epstein-Barr Virus viral capsid antigen (VCA) in human serum by ELISA. When the VCA IgM test is used in conjunction with other testing such as the EBV nuclear antigen (EBNA-1), VCA IgG, and EBV early antigen tests and/or heterophile tests, the results can serve as an aid in the diagnosis of infectious mononucleosis (IM).

Microtiter ELISA kit detecting VCA IgM antibodies

This document describes the ImmunoWELL VCA IgM Test, a microtiter ELISA kit designed for the qualitative detection of IgM antibodies to Epstein-Barr Virus (EBV) viral capsid antigen (VCA) in human serum. This test is intended to be used as an aid in diagnosing infectious mononucleosis (IM) when used alongside other EBV tests.

The submission claims substantial equivalence to the Epstein-Barr Viral Capsid Antigen IgM ELISA Kit by Gull Laboratories, Inc. Both devices utilize VCA affinity-purified antigen and measure antibodies using ELISA technology in a microtiter assay format.

Here's an analysis of the acceptance criteria and the study performance based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria (e.g., minimum sensitivity or specificity thresholds). Instead, the study's goal was to demonstrate substantial equivalence to the predicate device. The performance is reported in terms of agreement with the predicate device.

Note: The table presented in the input is a 2x2 contingency table comparing the ImmunoWELL VCA IgM Test (labeled "GB") against the Gull EIA.

From this table:

• True Negatives (both negative): 88
• False Negatives (ImmunoWELL negative, Gull positive): 1
• False Positives (ImmunoWELL positive, Gull negative): 0
• True Positives (both positive): 4

This implies:

• Total Gull Negative: 88
• Total Gull Positive: 5 (4+1)
• Total ImmunoWELL Negative: 89 (88+1)
• Total ImmunoWELL Positive: 4

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for the Test Set: 93 samples (88 negative by predicate + 4 positive by predicate + 1 discrepant). The table shows a total of 93 samples analyzed in the comparison study.
• Data Provenance: The document does not explicitly state the country of origin. It mentions "sera from suspected patients," suggesting these were patient samples collected in a clinical context. The study is retrospective, as it involves testing existing serum samples and comparing the results to a predicate device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The concept of "experts" and their qualifications for establishing ground truth is not applicable in this context. The "ground truth" for the test set is established by the results of the predicate device (Gull Laboratories' Epstein-Barr Viral Capsid Antigen IgM ELISA Kit). The study design compares the new device's results against those of an already legally marketed device, considering the predicate device's results as the reference.

4. Adjudication Method for the Test Set

No adjudication method is described for the test set. The comparison is a direct concordance analysis between the new device and the predicate device. Discrepancies (one sample was negative by ImmunoWELL but positive by Gull EIA) are noted, but no further adjudication (e.g., by a third expert or a tie-breaker rule) is mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This study focuses on the performance of a diagnostic kit, not on the interpretation skills of human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) was Done

Yes, this is a standalone study of the device (ELISA kit). The performance reported is that of the ImmunoWELL VCA IgM Test kit itself, without human interpretation as a variable. The "human-in-the-loop" concept is more relevant to imaging or AI-assisted diagnostic systems.

7. The Type of Ground Truth Used

The "ground truth" used for evaluating the ImmunoWELL VCA IgM Test was comparison to a legally marketed predicate device (Epstein-Barr Viral Capsid Antigen IgM ELISA Kit, Gull Laboratories, Inc.). The predicate device's results served as the reference standard for assessing the new device's performance.

8. The Sample Size for the Training Set

The document does not provide information on a "training set." This type of diagnostic device (ELISA kit) typically undergoes development and validation using laboratory methods, rather than machine learning training sets. Therefore, there's no mention of a traditional "training set" in the context of an algorithm.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of this device's development (which is assumed to be a traditional ELISA kit development rather than an AI algorithm), the establishment of ground truth for a training set is not applicable or described in the provided text.

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