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Immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to hepatitis A virus (HAV) in human pediatric (ages 2 through 21 years) and adult serum and plasma (Li-heparin, potassium EDTA, Na-hebarin). The assay, in conjunction with other serological and clinical information, is indicated as an aid in the clinical laboratory diagnosis of acute or past hepatitis A virus infection in persons with signs or symptoms of hepatitis and in persons at increased risk for hepatitis A infection, or as an aid to identify HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients.

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

Assay performance characteristics have not been established for immunocompromised or immunosuppressed patients. This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

Elecsys Anti-HAV II is a second generation assay by Roche Diagnostics for the in vitro qualitative detection of total antibodies (IgG and IgM) to the hepatitis A virus (HAV) in human pediatric (ages 2 through 21 years) and adult serum and plasma. It is intended for use on the cobas e 601 immunoassay analyzer. The cobas e family of analyzers employs the electrochemiluminescence "ECLIA" technology. The assay is an 18-minute assay utilizing a competition principle.

Results are determined automatically by the software by comparing the electrochemiluminescence signal obtained from the reaction product of the sample with the signal of the cutoff value previously obtained by calibration.

The reagent rackpack working solutions include:

• M: Streptavidin-coated microparticles .
• R1: HAV Ag (cell culture) .
• R2: Biotinylated monoclonal anti-HAV antibody, monoclonal Anti-HAV antibody . labeled with ruthenium complex
• AHAV 2 Cal1: Negative Calibrator 1 (human serum) .
• AHAV 2 Cal2: Positive Calibrator 2 (anti-HAV (human), approximately 60 IU/L in . human serum)

PreciControl Anti-HAV II is a ready-for-use control serum based on human serum both in the negative and positive concentration range. The controls are used for monitoring the performance of the Elecsys Anti-HAV II immunoassay. PreciControl Anti-HAV II is sold separately from the Elecsys Anti-HAV II immunoassay reagent.

The Elecsys Anti-HAV II is an immunoassay for the in vitro qualitative detection of total antibodies (IgG and IgM) to hepatitis A virus (HAV) in human pediatric (ages 2 through 21 years) and adult serum and plasma. Its purpose is to aid in the clinical laboratory diagnosis of acute or past hepatitis A virus infection in persons with signs or symptoms of hepatitis and in persons at increased risk for hepatitis A infection, or as an aid to identify HAV susceptible individuals and to determine the presence of an antibody response to HAV in vaccine recipients.

Here's an analysis of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Precision (Repeatability and Within-Laboratory Precision): 5 human serum sample pools and 2 PreciControl materials, tested in 2 aliquots per run, 2 runs per day for 21 days (total 84 measurements per sample/control).
• Analytical Sensitivity (Cut-off): 10 serially diluted samples of the 2nd International Standard for Anti-Hepatitis A, Immunoglobulin, Human, NIBSC code: 97/646. Tested fourfold with three different reagent and calibrator lots.
• HAMA Interference: 11 human serum samples, double positive for HAMA and anti-HAV antibodies.
• Endogenous Interferences (Hemoglobin/Bilirubin/Lipemia, Rheumatoid Factor, Serum Albumin/IgG/IgA/IgM): Four human serum samples for each interfering substance, tested in accordance with CLSI EP07-A2.
• Biotin Interference: Five human serum samples.
• Analytical Specificity/Cross-Reactivity: 12 sample pools, each containing 10 samples (total 120 samples) with antibodies to various infectious agents.
• Exogenous Interferences (Drugs): Four human serum samples (native human serum pools) for each of 18 pharmaceutical compounds.
• Sample Matrix Comparison: At least 60 serum/plasma pairs for each anticoagulant type (K2-EDTA, K3-EDTA, Na-Heparin, Li-Heparin, Na-Citrate).
• Analytical Method Comparison to Predicate: A total of 215 modified serum samples (≥100 negative and ≥100 positive samples).
• Reagent Stability:
  • After First Opening: 2 control samples and 7 samples, tested in duplicate.
  • On-Board Reagent Stability: 2 control samples (singleton) and 7 samples (duplicate).
• Calibration Stability:
  • Lot Calibration Stability: 2 control samples (singleton) and 7 human serum samples (duplicate).
  • On-Board Calibration Stability: 2 control samples (singleton) and 7 human serum samples (duplicate).
• Sample Stability:
  • 2-8°C, Room Temperature, -15 to -25°C, Freeze/Thaw Cycles: 6 human serum, K2-EDTA, Li-Heparin, and Na-Citrate plasma samples, and 7 K3-EDTA and Na-Heparin plasma samples.
• Reproducibility (External Testing): Four human serum pools and two PreciControl materials. Tested in 3 replicates per run, 2 runs per day for 5 days (total 90 measurements per sample/control per site).
• Method Comparison Versus Predicate (Clinical): 961 specimens from various cohorts.
  • Routine HAV testing: 91 PPA, 109 NPA
  • Hospitalized: 56 PPA, 144 NPA
  • Increased risk for hepatitis: 119 PPA, 87 NPA
  • Symptomatic: 129 PPA, 91 NPA
  • Characterized acute HAV: 65 PPA, 10 NPA
  • Pediatric: 42 PPA, 18 NPA
• Pre- and Post-HAV Vaccination: Specimens from 49 subjects.
• Prevalence Study: 400 evaluable subjects from a "high prevalence" region (Western US) and 400 evaluable subjects from a "low prevalence" region (Eastern US).

Data Provenance for Clinical Studies:
The method comparison and prevalence studies were conducted using specimens that are likely from the United States, as they reference "US- and non-US-obtained specimens" and "Western United States" and "Eastern United States" for the prevalence study. These studies appear to be prospective in nature, as they involve specimen collection for specific study purposes (e.g., cohorts for method comparison, pre- and post-vaccination, and prevalence studies with subjects recruited from specific regions).

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

The document does not explicitly state the number or qualifications of "experts" used to establish the ground truth in the traditional sense of consensus reading or clinical adjudication by medical specialists.

• For the method comparison study, the "ground truth" was established by the predicate device, Elecsys Anti-HAV assay (FDA-cleared). This means the predicate device's results were accepted as the reference against which the new device's performance was measured.
• For the Pre- and Post-HAV Vaccination study, the "ground truth" was established by the predicate assay (Elecsys Anti-HAV).
• For the Analytical Specificity/Cross-Reactivity study, samples were defined as "Anti-HAV negative samples containing potential cross-reacting antibodies to other infectious diseases," implying these diagnoses were previously established, likely through standard diagnostic tests.
• For the Prevalence study, the "ground truth" for HAV antibody status was determined by the Elecsys Anti-HAV II assay itself, as the study evaluated its performance in determining prevalence in different populations rather than comparing it to an external gold standard for individual cases.

4. Adjudication Method for the Test Set:

• None explicitly mentioned in the typical sense of expert review for ambiguous cases.
• For the Method Comparison study, discordant results were counted against the Elecsys Anti-HAV II when calculating agreement. Specifically, specimens with results in the borderline range of the predicate device (18.0 ≤ IU/L

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