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The Roche Elecsys Anti-HAV IgM immunoassay is used for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma (potassium EDTA, lithium or sodium heparin, sodium citrate). The assay is intended for use as an aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection.

Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with hepatitis A virus in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis A infection.

The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.

Elecsys PreciControl Anti-HAV IgM is used for quality control of the Elecsys Anti-HAV IgM immunoassay on the Elecsys and cobas e immunoassay analyzers.

The Elecsys Anti-HAV IgM immunoassay utilizes a u-capture test concept based on a monoclonal h-IgM directed biotinylated antibody, cell culture derived Hepatitis A Virus and a ruthenylated monoclonal antibody directed to HAV. Capture of formed immune complexes from the reaction mixture is based on biotin binding to streptavidin-coated magnetic microparticles which are collected on a measuring cell electrode. Signal generation is triggered by the application of a voltage to the electrode (electrochemiluminescence technology). The level of signal count detected by the system increases as the concentration of the IgM antibody target present in a patient sample increases.

The Elecsys PreciControl Anti-HAV IgM contains control serum based on human serum in the negative and positive concentration range. The controls are used for monitoring the accuracy of the Elecsys Anti-HAV IgM immunoassays.

The Elecsys® Anti-HAV IgM immunoassay is intended for the in vitro qualitative detection of IgM antibodies to hepatitis A virus (anti-HAV IgM) in human serum and plasma. The assay is meant to aid in the laboratory diagnosis of an acute or recently acquired hepatitis A virus infection.

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

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for sensitivity, specificity, or agreement. However, the study aims to demonstrate the performance of the Elecsys Anti-HAV IgM immunoassay by comparing it to an FDA-cleared reference method. The implicit acceptance criterion is a high level of agreement with the predicate device across various sample cohorts.

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

• Test Set Sample Size:
  • Comparative Testing (Clinical Performance): 1087 total samples.
  • Analytical Sensitivity: 3 commercially available HAV seroconversion panels.
  • Expected Values (Prevalence): 602 subjects (208 males, 394 females) from two US regions.
  • Cross-reactivity: 211 specimens representing various disease states.
  • Potentially Interfering Substances: Not explicitly stated, implied to be sufficient for 18 pharmaceuticals and other substances.
  • Serum and Plasma Comparison: 10 positive, 15 borderline, and 20 negative specimens per plasma matrix (Li-heparin, Na-heparin, K2-EDTA, Sodium citrate).
  • Precision/Reproducibility: Human serum pools (3) and controls (2) tested in replicates over multiple days/runs/sites.
• Data Provenance:
  • Clinical Performance: Multi-center study conducted in the U.S. Retrospective (samples were obtained for routine testing, from hospitalized patients, etc.).
  • Expected Values: Prospective study of apparently healthy individuals from New Mexico (high prevalence region) and Indiana (low prevalence region) in the U.S.
  • Other studies (Analytical Sensitivity, Cross-reactivity, Precision/Reproducibility, Interfering Substances, Serum/Plasma Comparison) are likely laboratory-based studies conducted by the manufacturer, with samples possibly sourced from commercial vendors or clinical sites.

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

The ground truth for the clinical performance study was established by an "FDA-cleared reference method." A second FDA-cleared anti-HAV IgM assay was used for discrepant analysis, and for a subset of concordant specimens.

• Number of Experts: Not applicable, as the ground truth was established by laboratory assays (reference methods), not by individual experts or a consensus thereof.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

For the comparative testing (clinical performance):

• The primary comparison was against a "1st reference anti-HAV IgM assay."
• Discrepant Analysis: For discrepant and several concordant samples, a "second FDA cleared anti-HAV IgM assay" was used for additional testing.
• Adjudication Rule: The second predicate agreed with the Elecsys outcome in 7 of 10 discrepant samples and with the first predicate in 2 of 10. No consensus was obtained in the remaining specimen.
• This indicates a form of 2-assay adjudication where a third assay (the Elecsys in this case) is compared against two reference assays. The "ground truth" for the overall agreement calculation appears to be based on the initial primary reference assay, with the secondary assay used to investigate discrepancies.

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

• No, an MRMC comparative effectiveness study was not done.
  • This device is an in vitro diagnostic (IVD) immunoassay, not an imaging or interpretation device that would typically involve multiple human readers. The performance is assessed in terms of agreement with a reference laboratory method.
• Effect Size of Human Readers with/without AI Assistance: Not applicable, as no human reader component or AI assistance is described for the interpretation of this immunoassay.

6. Standalone Performance Study

• Yes, a standalone study was done. The entire clinical performance section, particularly the "COMPARATIVE TESTING" and "ANALYTICAL SENSITIVITY" sections, evaluates the algorithm's (the immunoassay's) performance independently against established reference methods and panels. The reported Positive Percent Agreement and Negative Percent Agreement are measures of the device's standalone performance relative to the chosen reference.

7. Type of Ground Truth Used

• Expert Consensus: Not used for establishing the primary ground truth.
• Pathology: Not applicable.
• Outcomes Data: Not explicitly mentioned as the primary ground truth source.
• Reference Assay/Method: The primary ground truth for the clinical performance was established by an "FDA-cleared reference method" (the Abbott Axsym HAVAB-M 2.0 Assay). For discrepant samples, a second FDA-cleared anti-HAV IgM assay was used for further investigation. For analytical sensitivity, the ground truth was based on commercially available HAV seroconversion panels and comparator assays (Abbott Axym HAVAB-M 2.0 and Abbott HAVAB-M).

8. Sample Size for the Training Set

• Not explicitly stated within the provided document. IVD assays like this immunoassay typically undergo extensive laboratory development and optimization during which various samples might be used for "training" or optimization. However, the document focuses on the validation and performance testing of the finalized assay. Manufacturers often do not disclose specific "training set" sizes for IVD assays in 510(k) submissions, as the development process involves reagent formulation and analytical optimization rather than a distinct "machine learning training set" in the common sense.

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

• Not explicitly stated in the document. Similar to point 8, the specific methodology for establishing ground truth during the assay's development or "training" phase is not detailed. It is reasonable to assume that standard laboratory practices, including the use of well-characterized positive and negative control samples, reference materials, and expert knowledge of HAV infection serology, would have been employed during the optimization and development of the Elecsys Anti-HAV IgM immunoassay.

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