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For the qualitative determination of IgM antibodies in human serum to Epstein Barr (recombinant) Viral Capsid antigen (EBV-VCA) antigen. The EBV-VCA IgM assay should be used in conjunction with other Epstein-Barr serologies (EBV-VCA IgG, EBNA-1 IgG, EA-D IgG, EA-D IgM, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious monomucleosis. The test can be performed either manually or in conjunction with the MAGO PLUS ™ Automated EIA Processor.

The & EBV-VCA IgM ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgM antibodies to Epstein-Barr Viral Capsid antigen in human serum.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Device Name: EBV-VCA IgM ELISA Kit (also referred to as Is-EBV-VCA IgM Test Kit and 7 VCA IgM ELISA)

Study Details Proving Acceptance Criteria

1. Sample Size used for the test set and the data provenance:

   • Clinical Sensitivity and Specificity: 176 frozen retrospective sera. The provenance (country of origin) is not explicitly stated, but it's referred to as "sera from one hundred and seventy-six patients" which suggests human samples. The study explicitly states it was a "pre-selected, retrospective, population."
   • Precision:
     • Intra-assay and Interassay Precision: Four positive and two negative sera (6 unique sera) were assayed 10 times each, in 3 different runs. This was done at 3 different sites.
     • Inter-Site Precision: The document mentions n=90 for serum samples A-F (presumably 90 total measurements across sites for each serum type, or 3 sites * 3 runs * 10 replicates = 90 total for each serum type), and n=36 for CAL (Calibrator), n=18 for LPC (Low Positive Control), n=18 for NC (Negative Control).
   • Specificity with Potentially Cross-Reactive Sera: 13 sera.
   • Correlation of Manual and MAGO Plus Results: 120 serum samples.
   • MAGO Plus Precision: Six sera were assayed 10 times each in 3 different runs (similar to the manual precision study).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For the "Clinical Sensitivity and Specificity Using Characterized Sera" section, the sera were "characterized using commercially available kits for VCA IgM, VCA IgG, EBNA IgG and heterophile antibodies." This implies an established laboratory testing method rather than human expert opinion directly establishing ground truth for individual cases. No human experts are explicitly mentioned for ground truth establishment.

3. Adjudication method for the test set:

   • No adjudication method (e.g., 2+1, 3+1) is mentioned. The ground truth was established by comparing to results from "commercially available kits" for other EBV serologies.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This is not an MRMC study. The device is an ELISA kit, which is an in vitro diagnostic (IVD) test, not an AI-assisted diagnostic tool for human readers. There is no mention of human readers or AI assistance in this context. The comparison is between the new EBV-VCA IgM ELISA Kit and existing commercial kits/methods.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Yes, for the EBV-VCA IgM ELISA Kit, the performance data provided (sensitivity, specificity, precision, cross-reactivity) represents the standalone performance of the diagnostic assay. This assay is a laboratory test, and its results are read and interpreted, but the performance characteristics apply to the kit itself.
   • The "Correlation of Manual and MAGO Plus Results" section compares the standalone performance of the kit when processed manually versus using an automated EIA processor (MAGO Plus). Both are "standalone" in the sense of the chemical assay's performance.

6. The type of ground truth used:

   • Clinical Performance: "EBV Serological Status" derived from other "commercially available kits for VCA IgM, VCA IgG, EBNA IgG and heterophile antibodies." This is a lab result-based ground truth (or predicate method comparison) rather than pathology, clinical outcome, or expert consensus on a subjective measure. The document explicitly states: "There was not an attempt to correlate the assay's results with disease presence or absence."
   • Precision: Ground truth for positive/negative samples was pre-established (e.g., "four positive and two negative sera").
   • Cross-Reactivity: Sera "reactive for IgM antibodies to varicella zoster, cytomegalovirus and herpes simplex virus by EIA". This is again a lab result-based ground truth to check for specific antibody interference.
   • Correlation: Comparison between the manual and MAGO Plus results on the same samples.

7. The sample size for the training set:

   • The document does not explicitly describe a "training set" in the context of machine learning or AI. This is an in vitro diagnostic (IVD) assay. The development of such assays typically involves research and development where reagents and protocols are optimized. The "Characterized Sera" mentioned in the clinical performance section serves as the test set for the final validation of the device.

8. How the ground truth for the training set was established:

   • As no "training set" in the AI sense is explicitly mentioned, this question is not fully applicable. For the development and optimization of the ELISA kit itself, ground truth for sample characterization would have been established through well-characterized reference materials, clinical samples with known serological status using predicate methods, or samples from a disease registry. The "Characterized Sera" in the performance study were characterized using "commercially available kits for VCA IgM, VCA IgG, EBNA IgG and heterophile antibodies," which indicates the method used to establish the "ground truth" for those specific samples relative to established serological definitions.

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

The Wampole Epstein-Barr Viral Capsid Antigen (VCA) IgM kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the qualitative determination of IgM antibodies in human serum to VCA antigen. The Wampole anti-VCA IgM assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, EBNA-1 IgG, EA-D IgG, EBNA-1 IgM and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only. The VCA IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Epstein-Barr Viral Capsid antigen. Afinity purified gp125 VCA 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 IgM 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 a breakdown of the acceptance criteria and the study details for the Wampole VCA IgM ELISA Test Kit, based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the Wampole VCA IgM ELISA Test Kit are based on its performance in terms of sensitivity and specificity, as demonstrated by the serum characterization study.

Note: The document does not explicitly state numerical acceptance thresholds (e.g., "sensitivity must be >95%"). Instead, the reported performance metrics serve as the basis for demonstrating substantial equivalence to the predicate device.

Study Details

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

• Test Set Sample Size: 166 selected serum samples.
• Data Provenance: The text states, "One hundred and sixty six selected serum were tested at a clinical lab." This suggests the data is retrospective, as the serum samples were "selected" and "characterized," implying they were already collected and categorized before the study. The country of origin is not specified, but the submission is to the U.S. FDA, so it's likely U.S.-based or from a region with similar clinical practices.

2. Number of Experts Used to Establish the 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 ground truth. The ground truth ("seronegative," "acute," or "seropositive" EBV infection) was established based on a panel of other Epstein-Barr serologies (VCA IgM, heterophile antibody, EBNA IgG, VCA IgG). It is implied that these serological profiles, rather than individual expert opinions, served as the basis for characterization.

3. Adjudication Method for the Test Set

The document does not detail an adjudication method. The characterization of serum samples (acute, seropositive, seronegative) was based on the presence or absence of specific markers from a panel of EBV serologies. It's an objective classification based on laboratory results, not subjective interpretation requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. This study evaluates an in vitro diagnostic device (ELISA kit), not an AI system or imaging device where human reader performance would be a primary metric.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this study represents a standalone performance evaluation of the Wampole VCA IgM ELISA Test Kit. The test kit itself is the "algorithm" or device being evaluated, and its performance (sensitivity, specificity, precision, cross-reactivity) is assessed directly against the established ground truth of the serum samples. There is no human-in-the-loop interaction being measured for diagnostic performance, other than the standard laboratory procedures for running the assay.

6. The Type of Ground Truth Used

The ground truth used was expert serological characterization. This was based on a panel of established serological markers for Epstein-Barr Virus infection:

• Acute: VCA IgM present, EBNA IgG absent, Heterophile antibody present.
• Seropositive (Past infection): VCA IgG present, EBNA IgG present, VCA IgM absent, Heterophile antibody absent.
• Seronegative: VCA IgG absent, EBNA IgG absent, VCA IgM absent, Heterophile antibody absent.

This method relies on established clinical and laboratory diagnostic criteria to define the true state of EBV infection for each sample.

7. The Sample Size for the Training Set

The document does not report a separate training set or its sample size. This type of diagnostic device (ELISA kit) typically undergoes development and optimization before an official performance study. The data presented here is for the validation/test phase of the device.

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

As no specific training set is reported, the method for establishing its ground truth is also not mentioned. For the development and optimization of such assays, manufacturers generally use well-characterized clinical samples or panels from reference laboratories.

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