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The ADVIA Centaur EBV-EBNA IgG (EBVnaG) assay is for in vitro diagnostic use in the qualitative detection of IqG antibodies to Epstein-Barr virus (EBV) nuclear antigen (EBNA) in human pediatric (2-21 years old) and adult serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XP system. When used in conjunction with other EBV markers, this assay is intended for use as an aid in the diagnosis of Epstein-Barr virus infection, such as infectious mononucleosis.

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The provided text describes the performance of the ADVIA Centaur EBV-EBNA IgG assay, an in vitro diagnostic device for the qualitative detection of IgG antibodies to Epstein-Barr virus (EBV) nuclear antigen (EBNA).

Here's an analysis of the acceptance criteria and study data:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the ADVIA Centaur EBV-EBNA IgG assay are primarily demonstrated through its agreement with an FDA-cleared reference EBV EBNA IgG assay. While explicit "acceptance criteria" are not listed with numerical thresholds in a dedicated table, the clinical study results (Positive Percent Agreement - PPA and Negative Percent Agreement - NPA) are implicitly compared against an expectation of substantial equivalence to the predicate device.

For precision and reproducibility, specific targets are mentioned.

• NPA: 92.8% (95% CI: 89.6% - 95.1%)
• PPA: 99.4% (95% CI: 98.8% - 99.7%)

Population 2 (Known EBV EBNA IgG negative individuals)

• NPA: 98.2% (95% CI: 94.9% - 99.4%)

Pediatric Population (Population 1 - symptomatic)

• NPA: 97.3% (95% CI: 94.3% - 98.8%)
• PPA: 98.4% (95% CI: 96.0% - 99.4%)

Pediatric Population (Population 2 - known negative)

• NPA: 100% (95% CI: 94.9% - 100%) |
  | Precision | Not explicitly stated as a single value, but individual sample CVs are presented. | Serum Samples: Total Precision CVs range from 4.4% to 13.3%.
  Plasma, EDTA Samples: Total Precision CVs range from 4.3% to 9.5%.
  Controls: Control 1 (0.32 Index) Total Precision SD 0.014; Control 2 (3.16 Index) Total Precision CV 4.1%. |
  | Reproducibility | - Concentration $\le$ 0.80 Index: N/A (for CV)
• Concentration > 0.80 Index: $\le$ 20.0% CV | Serum Samples:
• Serum A (0.77 Index): SD 0.048, CV N/A (within $\le$ 0.80 Index)
• Serum B-E (1.07 to 8.85 Index): CVs range from 4.0% to 9.8% (all $\le$ 20.0%)
  Plasma, EDTA Samples:
• Plasma A (0.78 Index): SD 0.044, CV N/A (within $\le$ 0.80 Index)
• Plasma B-E (1.06 to 8.75 Index): CVs range from 5.0% to 10.7% (all $\le$ 20.0%)
  Controls: Control 1 (0.36 Index) SD 0.022, CV N/A; Control 2 (3.31 Index) CV 4.0%. |
  | Specimen Equivalency | Regression equation close to y=x, high correlation coefficient (r). | EDTA Plasma vs. Serum: y = 1.00x - 0.01 Index; r = 1.00
  Lithium Heparin Plasma vs. Serum: y = 0.98x - 0.01 Index; r = 0.99
  Conclusion: EDTA Plasma and Lithium Heparin Plasma are equivalent matrixes to Serum. |
  | Interferences | ±10% bias for reactive samples and ±0.10 Index for nonreactive samples. | The listed substances (Hemoglobin, Bilirubin, Lipemia, Biotin, Cholesterol, Protein, etc.) do not interfere at the indicated concentrations. |
  | Cross-reactivity | Not explicitly stated as a numerical criterion, but demonstrated by testing against various viral antibodies and disease states. | Data presented for 330 samples across 29 clinical categories, showing agreement or defined discrepancies with the comparative assay. For HCV, Mycoplasma pneumoniae IgG, HSV-1 IgG, and HSV-2 IgG, possible cross-reactivity cannot be excluded for a few discordant samples and should be interpreted clinically. |
  | Onboard Stability | 28 days for reagents, 28 days for calibration. | Reagents: 28 days. Calibration: 28 days. |
  | Calibrator Stability (Opened Vial) | 60 days when stored at 2-8ºC. | 60 days when stored at 2-8ºC. |
  | Unopened Reagents/Calibrators Stability | Until expiration date when stored at 2-8°C. | Until expiration date when stored at 2-8°C. |

2. Sample Size and Data Provenance

Clinical Study (Test Set):

• Total Study Population (Population 1): 1428 leftover samples.
  • Provenance: Collected over a contiguous time period from individuals for whom an EBV test was ordered. The document does not specify the country of origin but implies a clinical setting ("symptoms and signs for whom an EBV antibody test was ordered"). It is a retrospective collection of leftover samples.
• Known EBV EBNA IgG Negative Population (Population 2): 167 samples.
  • Provenance: Samples with a known EBV EBNA IgG negative result, used to supplement numbers for negative EBV EBNA IgG. Retrospective.
• Pediatric Population: Subsets of Population 1 (479 samples including 84 unclassified serostatus individuals) and Population 2 (72 samples including 6 unclassified serostatus individuals).
• Cross-reactivity Study: 330 samples across various clinical categories.
• Specimen Equivalency Study: 97-98 sets of matched samples (SST, EDTA plasma, lithium heparin plasma).
  • Provenance: Commercial sources.

3. Number of Experts and Qualifications for Ground Truth

The document explicitly states that the ground truth for the clinical study was established by an "FDA cleared EBV EBNA IgG reference assay."
It also states: "Equivocal reference assay results were resolved by 2 other comparative assays."

• Number of 'Experts' (resolving assays): 2 (for equivocal cases from the primary reference assay).
• "Qualifications" of these 'experts': These were "comparative assays" rather than human experts. The document does not specify if these were other FDA-cleared assays or the nature of their qualification, but the implication is that they served as a consensus mechanism to resolve indeterminate results from the primary reference assay.

4. Adjudication Method for the Test Set

The adjudication method for equivocal results from the primary reference assay was by "2 other comparative assays." This is a form of 2+0 or 1+2 (primary reference + 2 comparative). If the two comparative assays agreed, that likely established the reconciled ground truth for the equivocal samples. The document does not describe what happened if the two comparative assays disagreed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was done. This device is an in vitro diagnostic assay, which typically does not involve human readers interpreting images or data alongside AI. The device is evaluated for its analytical and clinical performance against a reference method. Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.

6. Standalone (Algorithm only without human-in-the loop performance)

Yes, a standalone performance study was done. The entire clinical study, precision, reproducibility, specimen equivalency, and interference studies evaluate the performance of the ADVIA Centaur EBV-EBNA IgG assay as a standalone device (algorithm/assay only) against a reference method or predetermined analytical specifications. There is no human-in-the-loop component described for its primary intended use and evaluation.

7. Type of Ground Truth Used

The ground truth used for the clinical study was based on an FDA-cleared EBV EBNA IgG reference assay, with equivocal results resolved by 2 other comparative assays. This indicates a reference method or comparative assay-based ground truth.

8. Sample Size for the Training Set

The document is a 510(k) summary for an in vitro diagnostic assay. It does not provide information regarding a "training set" in the context of machine learning or AI models.
The samples mentioned are for performance evaluation (clinical study, precision, etc.) and are analogous to test or validation sets. For IVD devices, a "training set" might refer to samples used during the development and optimization of the assay's reagents and parameters, but this information is not typically disclosed in a 510(k) summary in this format.

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

As there is no "training set" described in the context of an AI/ML model for this IVD assay according to the provided document, this information is not applicable and not available.

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The DiaSorin LIAISON® EBNA IgG kit uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IgG antibodies to EBV nuclear antigen synthetic peptide (EBNA) in human serum. When performed in conjunction with other EBV marker tests, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control EBNA IgG kit is used in conjunction with LIAISON® EBNA IgG immunoassay for quality control of assay runs.

The LIAISON® EBV IgM assay uses chemiluminescent immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative determination of IgM antibodies to Epstein-Barr virus (EBV) viral capsid antigen (VCA) p-18 synthetic peptide in human serum. When performed in conjunction with other EBV markers, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control EBV IgM kit is used in conjunction with LIAISON® EBV IgM immunoassay for quality control of assay runs.

The DiaSorin LIAISON® VCA IgG kit uses chemiluminescence immunoassay (CLIA) technology on the LIAISON® Analyzer for the qualitative detection of specific IqG antibodies to EBV viral capsid antigen (VCA) p-18 synthetic peptide in human serum. When performed in conjunction with other EBV marker tests, this assay can be used as an aid in the clinical laboratory diagnosis of Epstein-Barr viral Syndrome in patients with signs and symptoms of EBV infection such as infectious mononucleosis (IM). LIAISON® Control VCA IgG kit is used in conjunction with LIAISON® VCA IgG immunoassay for quality control of assay runs.

The method for qualitative determination of specific IgG to EBNA is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with EBNA-1 synthetic peptide and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, EBNA antibodies present in the calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with EBNA IgG already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of EBNA IgG in calibrators, samples or controls.

The method for qualitative determination of specific IgM to Epstein-Barr viral capsid antigens (VCA) is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Chemiluminescence Analyzer. The principal components of the test are magnetic particles (solid phase) coated with p18 synthetic peptide and a conjugate of mouse monoclonal antibody to human IgM linked to an isoluminol derivative (isoluminolantibody conjugate). In the first step, samples and controls are diluted with Buffer A, which contains goat IgG to human IgG as an absorbent reagent to curb interference from human IgG specific to VCA or from rheumatoid factor. During the first incubation, VCA IgM antibodies present in the calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with VCA IgM already bound to the solid phase. After each incubation, the unbound material is removed with a wash cycle. Subsequently, the starter reagents are added and a flash chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured hy a photomultiplier as relative light units (RLU) and is indicative of the presence of VCA IgM in calibrators, samples or controls.

The method for qualititative determination of specific IgG to EBV viral capsid antigen (VCA) is an indirect chemiluminescence immunoassay (CLIA). All assay steps (with the exception of magnetic particle resuspension) and incubations are performed by the LIAISON® Analyzer. The principal components of the test are magnetic particles (solid phase) coated with EBV VCA p-18 synthetic peptide and a conjugate of mouse monoclonal antibody to human IgG linked to an isoluminol derivative (isoluminol-antibody conjugate). During the first incubation, VCA IgG antibodies present in calibrators, samples or controls bind to the solid phase. During the second incubation, the antibody conjugate reacts with VCA IgG antibodies that are already bound to the solid phase. After each incubation, unbound material is removed Subsequently, the starter reagents are added and a flash with a wash cycle. chemiluminescence reaction is thus induced. The light signal, and hence the amount of isoluminol-antibody conjugate, is measured by a photomultiplier as relative light units (RLU) and is indicative of the presence of EBV VCA IgG antibodies present in calibrators, samples or controls.

Here's an analysis of the acceptance criteria and study details for the DiaSorin LIAISON® EBNA IgG, LIAISON® EBV IgM, and LIAISON® VCA IgG assays, based on the provided text.

DiaSorin LIAISON® EBNA IgG Assay

This device is an immunoassay for the qualitative detection of IgG antibodies to EBV Nuclear Antigen (EBNA). It is intended to aid in the clinical diagnosis of Epstein-Barr viral Syndrome when used with other EBV marker tests.

1. Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria for the DiaSorin LIAISON® EBNA IgG assay. However, performance is evaluated by "Percent Agreement" with a predicate device (DiaSorin ETI-EBNA-G Kit) and with serological classifications based on multiple reference assays. The conclusion states that the device showed "equivalent performance to the corresponding FDA-cleared assay" and "demonstrated agreement with the comparison method higher then 95% among prospectively collected samples and 94% among selected retrospective samples."

Assuming the predicate device's performance benchmarks implicitly serve as acceptance criteria, here's a table based on the reported agreement:

Table of Acceptance Criteria (Implied) and Reported Device Performance for LIAISON® EBNA IgG

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Prospective Samples:
    • Comparison to Predicate: 823 samples
    • Comparison to Serological Classification: 819 samples (4 samples omitted due to insufficient volume)
  • Retrospective Samples:
    • Comparison to Predicate: 70 samples (VCA IgM-positive)
    • Comparison to Serological Classification: 70 samples
• Data Provenance: The clinical trials were conducted at "two external US laboratories and at DiaSorin." The samples were described as "repository and prospective samples." This indicates a mix of retrospective (repository) and prospective data, all from the USA.

3. Number of Experts and Qualifications for Ground Truth

The text does not mention the use of experts to establish ground truth. The ground truth for comparative clinical trials was based on:
* Predicate device: DiaSorin ETI-EBNA-G Kit.
* Serological classification: A panel of three reference assays (VCA IgG, EBNA-1 IgG, VCA IgM ELISA).

4. Adjudication Method

No explicit adjudication method (e.g., 2+1, 3+1) is described for resolving discrepancies or establishing ground truth. Agreement was determined by direct comparison to the predicate device and serological classification.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or described. This is an in-vitro diagnostic device, not an imaging AI device that involves human readers.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The performance data presented (e.g., percent agreement) reflects the algorithm-only performance of the DiaSorin LIAISON® EBNA IgG assay against the predicate and against serological classifications.

7. Type of Ground Truth Used

The ground truth used was:

• Comparison to a predicate device: DiaSorin ETI-EBNA-G Kit (an existing FDA-cleared immunoassay).
• Serological classification: Established by the results of three reference assays (VCA IgG, EBNA-1 IgG, VCA IgM ELISA). This acts as a composite "truth" for different EBV infection stages.

8. Sample Size for Training Set

No information is provided about a separate training set. Immunoassays typically do not have "training sets" in the same way machine learning algorithms do. The development and validation process relies on reagents, calibration, and analytical performance studies rather than data-driven model training.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no described training set for this type of device.

DiaSorin LIAISON® EBV IgM Assay

This device is an immunoassay for the qualitative detection of IgM antibodies to EBV Viral Capsid Antigen (VCA) p-18 synthetic peptide. It is intended to aid in the clinical diagnosis of Epstein-Barr viral Syndrome when used with other EBV marker tests.

1. Acceptance Criteria and Reported Device Performance

Similar to the EBNA IgG assay, the provided text does not explicitly state pre-defined acceptance criteria. Performance is evaluated by "Percent Agreement" with a predicate device (DiaSorin ETI-EBV-M reverse ELISA Kit) and with serological classifications. The conclusion states the device "demonstrated agreement with the comparison method higher than 89% among prospectively collected samples and 95% agreement among retrospective selected samples."

Table of Acceptance Criteria (Implied) and Reported Device Performance for LIAISON® EBV IgM

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Prospective Samples: 819 samples (for both predicate and serological classification comparison).
  • Retrospective Samples: 70 samples (VCA IgM-positive) (for both predicate and serological classification comparison).
• Data Provenance: The clinical trials were conducted at "two external US laboratories and at DiaSorin." The samples were described as "repository and prospective samples." This indicates a mix of retrospective (repository) and prospective data, all from the USA.

3. Number of Experts and Qualifications for Ground Truth

Not mentioned. Ground truth derived from a predicate device and a panel of three reference assays (VCA IgG, EBNA-1 IgG, VCA IgM ELISA).

4. Adjudication Method

No explicit adjudication method described. Agreement was determined by direct comparison to the predicate device and serological classification.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or described. This is an in-vitro diagnostic device.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The performance data presented reflects the algorithm-only performance of the DiaSorin LIAISON® EBV IgM assay against the predicate and against serological classifications.

7. Type of Ground Truth Used

The ground truth used was:

• Comparison to a predicate device: DiaSorin ETI-EBV-M reverse ELISA Kit (an existing FDA-cleared immunoassay).
• Serological classification: Established by the results of three reference assays (VCA IgG, EBNA-1 IgG, VCA IgM ELISA).

8. Sample Size for Training Set

No information is provided about a separate training set.

9. How Ground Truth for Training Set Was Established

Not applicable.

DiaSorin LIAISON® VCA IgG Assay

This device is an immunoassay for the qualitative detection of IgG antibodies to EBV Viral Capsid Antigen (VCA) p-18 synthetic peptide. It is intended to aid in the clinical diagnosis of Epstein-Barr viral Syndrome when used with other EBV marker tests.

1. Acceptance Criteria and Reported Device Performance

The text presents performance in "Percent Agreement" with a predicate device (DiaSorin ETI-VCA-G Kit) and with serological classifications. The conclusion states the device "demonstrated agreement with the comparison method higher then 96% among prospectively collected samples and 100% agreement among retrospective selected samples."

Table of Acceptance Criteria (Implied) and Reported Device Performance for LIAISON® VCA IgG

2. Sample Size and Data Provenance

• Test Set Sample Size:
  • Prospective Samples:
    • Comparison to Predicate: 823 samples
    • Comparison to Serological Classification: 819 samples (4 samples omitted due to insufficient volume)
  • Retrospective Samples: 70 samples (VCA IgM-positive) (for both predicate and serological classification comparison).
• Data Provenance: The clinical trials were conducted at "two external US laboratories and at DiaSorin." The samples were described as "repository and prospective samples." This indicates a mix of retrospective (repository) and prospective data, all from the USA.

3. Number of Experts and Qualifications for Ground Truth

Not mentioned. Ground truth derived from a predicate device and a panel of three reference assays (VCA IgG, EBNA-1 IgG, VCA IgM ELISA).

4. Adjudication Method

No explicit adjudication method described. Agreement was determined by direct comparison to the predicate device and serological classification.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No MRMC study was performed or described. This is an in-vitro diagnostic device.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The performance data presented reflects the algorithm-only performance of the DiaSorin LIAISON® VCA IgG assay against the predicate and against serological classifications.

7. Type of Ground Truth Used

The ground truth used was:

• Comparison to a predicate device: DiaSorin ETI-VCA-G Kit (an existing FDA-cleared immunoassay).
• Serological classification: Established by the results of three reference assays (VCA IgG, EBNA-1 IgG, VCA IgM ELISA).

8. Sample Size for Training Set

No information is provided about a separate training set.

9. How Ground Truth for Training Set Was Established

Not applicable.

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This test system is designed for the manual or automated, qualitative detection of IgG antibodies to EBNA in human serum specimens. When used with other EBV serologies such as Heterophile, VCA IgG an VCA IgM, this test system may aid in the diagnosis and provide information on infectious mononucleosis that may be of value in patient management and treatment. The test is for in vitro diagnostic use.

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The provided text is a 510(k) clearance letter from the FDA for a device called "The Aptus (automated) Application of the EBNA IgG ELISA Test System." This letter only states that the device is substantially equivalent to a legally marketed predicate device and grants permission to market it. It does not contain the detailed study information, acceptance criteria, or performance data that you are requesting.

Therefore, I cannot provide the specific answers to your questions based on the input text. The document is essentially a regulatory approval notice, not a scientific study report.

To answer your questions, I would need a different type of document, such as:

• A clinical study report
• A validation report
• The 510(k) summary (which might contain a brief overview of performance data but usually not in the level of detail you're asking for)
• The Instructions for Use (IFU) for the device, which often contains performance characteristics.

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

Microtiter ELISA kit detecting EBNA antibodies

The provided text describes a 510(k) premarket notification for the "ImmunoWELL EBNA IgG Test" and its substantial equivalence to a predicate device. This document focuses on the performance of an in vitro diagnostic (IVD) device and not an AI/ML powered medical device. Therefore, several requested categories are not applicable.

Here's an analysis of the acceptance criteria and study data presented:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of specific sensitivity, specificity, or agreement percentages. Instead, the criterion for acceptance seems to be demonstrating "substantial equivalence" to a legally marketed predicate device. The performance is presented as a comparison table between the new device and the predicate.

Table 1: Gull EIA vs. ImmunoWELL EBNA IgG Test Performance (Clinical Samples)

Interpretation of Table 1:
The table compares the classification of patient samples by the new ImmunoWELL EBNA IgG Test against the predicate Gull EIA. The diagonal elements (65, 7, 8) represent agreement between the two devices. Off-diagonal elements represent disagreement. For example:

• 65 samples were classified as "Past/Recent" by both devices.
• 8 samples were classified as "Past/Recent" by ImmunoWELL but "Current" by Gull EIA.
• 5 samples were classified as "No Past Infection" by ImmunoWELL but "Past/Recent" by Gull EIA.

The summary states the predicate and new device "perform essentially the same when testing sers from suspected patients."

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

• Sample Size for Test Set: The total number of samples used in the comparison study (Table 1) is 70 + 16 + 8 = 94 samples.
• Data Provenance: The document does not explicitly state the country of origin. It describes the samples as "sérums from suspected patients," implying prospective or retrospective clinical samples from a patient population relevant to the intended use. It does not explicitly state whether it’s retrospective or prospective.

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

• Not Applicable. For an IVD device, the "ground truth" is typically established by either a reference method, confirmed clinical diagnosis, or a composite reference standard, rather than expert interpretation of images or other subjective data. In this case, the predicate device (Gull EIA) serves as the comparator for performance, effectively acting as an established "truth" for comparison within the context of substantial equivalence.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1 for consensus readings) are typically used when human interpretation is the primary method of establishing ground truth or performance. For this IVD comparison, the results are quantitative or qualitative classifications from two different assays, making an adjudication method unnecessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

• Not Applicable. This is an IVD device study, not an AI-powered image analysis or diagnostic support system that typically involves multiple human readers evaluating cases with and without AI assistance. Therefore, an MRMC study and effect size in terms context of AI assistance are not relevant here.

6. If a Standalone Performance (Algorithm only without human-in-the-loop performance) was done

• Yes, a standalone performance study was done. The entire study described by Table 1 is a standalone performance comparison. The ImmunoWELL EBNA IgG Test, like the predicate, is an assay that produces an output (qualitative detection of IgG antibody) without immediate human-in-the-loop intervention during the assay execution and primary result generation. The interpretation of the results "in conjunction with other testing" is part of clinical utility, but the device performance itself is standalone.

7. The Type of Ground Truth Used

• The "ground truth" in this context is implicitly the results obtained from the legally marketed predicate device (Gull Laboratories' Epstein-Barr Nuclear Antigen (EBNA) IgG ELISA Kit). The study's goal is to demonstrate that the new device's results are "essentially the same" as those from the predicate.

8. The Sample Size for the Training Set

• Not applicable. The "ImmunoWELL EBNA IgG Test" is an ELISA kit, which is a biochemical assay, not an AI/ML algorithm that requires a training set in the conventional sense. The development of such a kit involves reagent optimization and validation, but not machine learning training.

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

• Not applicable. As this is not an AI/ML device, there is no training set or associated ground truth for training in the sense of machine learning.

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

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

For In Vitro Diagnostic Use Only.

The EBNA-1 IgM ELISA test is an enzyme linked immunosorbent assay to detect IgM antibodies to Epstein-Barr Nuclear Antigen -1. Recombinant EBNA-1 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 an analysis of the provided information regarding the EBNA-1 IgM ELISA Test Kit, presented with the requested structure:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in the provided text. However, based on the presented performance characteristics, we can infer the implied targets for sensitivity and specificity. The study demonstrates performance against these inferred criteria.

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The ImmunoProbe anti-EBNA-1 IgG assay may be used in conjunction with other Epstein-Barr serologies (VCA IgG, VCA IgM, EA (R&D), and heterophile) as an aid in the diagnosis of infectious mononucleosis. For In Vitro Diagnostic Use Only.

The Epstein-Barr Virus Nuclear Antigen 1 (EBNA-1) IgG kit is an Enzyme-Linked Immunosorbent Assays (ELISA) for the semi-quantitative determination of IgG antibodies in human serum to EBNA-1 antigen. The EBNA-1 IgG EIA test is an enzyme linked immunosorbent assay to detect IgG antibodies to EBNA-1. Purified recombinant EBNA-1 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.

This document describes the performance characteristics of the Immuno Probe EBNA-1 IgG EIA Test Kit (K951549) and presents studies to demonstrate its safety and effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EBNA-1 IgG EIA Test Kit are not explicitly stated as distinct, pre-defined thresholds in the provided text. Instead, the document presents performance characteristics and demonstrates that the device's results are in line with a predicate device and expected clinical serological profiles for EBNA-1 IgG. Based on the "Performance Characteristics" section, we can infer the following performance metrics and observed results:

2. Sample size used for the test set and the data provenance

• Relative sensitivity and specificity (vs. predicate):
  • Sample Size: 350 total specimens (276 positive, 74 negative). 8 equivocal results were excluded.
  • Data Provenance: The study was conducted at three different sites: two R&D laboratories at commercial companies (Maryland and New York) and one large commercial lab (Pennsylvania). The data is retrospective, as it compares the new device's performance against an "alternate commercially available EIA assay" implying existing specimens.
• Precision:
  • Sample Size: For each of the four sera (High Positive, Mid Positive, Low Positive, Negative) and two controls (Calibrator, High Positive Control), samples were tested 3 times, twice a day for 20 days at 3 sites.
    • This totals to 3 * 2 * 20 * 3 = 360 individual assay points for each serum type across all sites (though the table states n=360 for "Inter Site Precision", implying this is the total number of data points aggregated for the CV calculation, not necessarily 360 distinct patient samples).
    • Calibrator: n=240
    • High Positive Control: n=120
  • Data Provenance: Three different sites (locations not specified beyond "different sites"). Likely prospective as these were controlled runs of known sera/controls.
• Linearity:
  • Sample Size: 5 different sera were serially diluted and tested.
  • Data Provenance: Not specified, but likely laboratory-generated data as it involves controlled serial dilutions.
• Cross-Reactivity:
  • Sample Size: 5 sera known to contain antibodies to HSV I & II, CMV, and VZV.
  • Data Provenance: Not specified, but likely laboratory-generated data from specific known-positive samples.
• Evaluation of paired sera:
  • Sample Size: 20 high positive sera were serially diluted to create 68 paired samples with a four-fold dilution.
  • Data Provenance: Not specified, but likely laboratory-generated from existing high-positive samples.
• Sensitivity and Specificity Based on Serum Characterization:
  • Sample Size: 150 specimens (95 seropositive, 24 acute, 31 seronegative). 8 equivocal results were excluded.
  • Data Provenance: The serum was from "the first study site" which implies one of the sites mentioned in the relative sensitivity/specificity study. The characterization (seronegative, acute, seropositive) suggests these were clinical samples. The study is likely retrospective, using samples with pre-established serological profiles.

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

The document does not explicitly state the number or qualifications of experts used to establish the ground truth.

• For Relative Sensitivity/Specificity: The ground truth for the comparison was an "alternate commercially available EIA assay." It is implied that the results from this predicate device are considered the truth for this comparison. The "experts" would implicitly be the developers and users of this predicate device, whose qualifications are not detailed.
• For Sensitivity/Specificity Based on Serum Characterization: The ground truth was established by classifying sera as "seronegative," "acute," or "seropositive" based on "other Epstein-Barr serologies (VCA IgG, VCA IgM)." This implies a determination made by laboratory personnel or serologists who follow established diagnostic protocols. No specific number or qualifications are provided.

4. Adjudication method for the test set

The document does not describe an adjudication method involving multiple readers for the test sets. The results appear to be based on direct laboratory measurements and comparisons to a predicate device or established serological profiles. "Equivocals were not included in the calculations" for the relative sensitivity/specificity and the serum characterization studies, which acts as a form of exclusion rather than an adjudication process to assign true status.

5. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an Enzyme-Linked Immunosorbent Assay (ELISA), which is an in vitro diagnostic test, not an AI-powered diagnostic imaging or interpretation tool that would typically involve human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.

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

Yes, the studies presented are all standalone performance evaluations of the assay itself. The results (e.g., optical density readings converted to index values) are generated by the kit components and detected instrumentally, without a human-in-the-loop interpretation step that influences the primary measurement outcome beyond standard laboratory procedures for running an ELISA.

7. The type of ground truth used

• For Relative Sensitivity and Specificity: The ground truth was based on the results of a "commercially available EIA assay" (predicate device).
• For Sensitivity and Specificity Based on Serum Characterization: The ground truth was based on serological characterization using other established EBV serologies (VCA IgG, VCA IgM) to classify samples as seronegative, acute, or seropositive. This falls under the category of established diagnostic criteria.
• For Precision, Linearity, Cross-Reactivity, Paired Sera: The ground truth was based on known characteristics of the samples used (e.g., known positive/negative samples for precision, serially diluted samples for linearity, samples with known viral antibodies for cross-reactivity).

8. The sample size for the training set

The document does not explicitly mention a "training set" in the context of machine learning or algorithm development. The device is a traditional immunoassay kit, not an AI/ML algorithm. Therefore, no specific training set data is described for this type of device. The extensive testing described in the document serves as performance validation.

9. How the ground truth for the training set was established

As there is no AI/ML algorithm and thus no explicit "training set" described, this question is not applicable. The performance characteristics were established by testing against established serological methods and clinical classifications, which serve as the reference standard or "ground truth" for validation.

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