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The Access® AFP assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of alpha-fetoprotein (AFP) in human serum using the Access Immunoassay System. AFP measured by the Access AFP Immunoassay, is used as an aid in the management of patients with nonseminomatous testicular cancer.

The ACCESS® AFP Immunoassay Reagents and the ACCESS® Immunoassay Analyzer comprise the ACCESS® Immunoassay System for the quantitative determination of AFP in human serum.

{
  "acceptance_criteria_and_study": {
    "table_of_performance": [
      {
        "criterion": "Correlation with Predicate Device (Abbott IMx AFP assay)",
        "acceptance_criteria": "Not explicitly stated, but typically highly correlated (e.g., r > 0.95 and slope near 1, intercept near 0)",
        "reported_performance": "r = 0.99; y = 0.91x + 3.86 (indicating very good agreement)"
      },
      {
        "criterion": "Expected Range (Healthy individuals)",
        "acceptance_criteria": "Typically, a high percentage of healthy individuals should fall within a defined reference range.",
        "reported_performance": "98.9% of 177 healthy individuals had AFP values ≤ 9.0 ng/mL. 1.1% had values in the 9.1 to 15 ng/mL range."
      },
      {
        "criterion": "Monitoring Data (Nonseminomatous Testicular Cancer Patients)",
        "acceptance_criteria": "High concordance with predicate device results and concurrent clinical assessment in monitoring patient status.",
        "reported_performance": "Results were highly concordant to both the IMx AFP results and concurrent clinical assessment."
      },
      {
        "criterion": "Recovery (Linearity studies)",
        "acceptance_criteria": "Typically a range of 90-110% recovery.",
        "reported_performance": "96 to 110% recovery for diluted samples."
      },
      {
        "criterion": "Recovery (Spiked samples)",
        "acceptance_criteria": "Typically a range of 90-110% recovery.",
        "reported_performance": "Average 99% recovery, with individual recoveries ranging from 90 to 108%."
      },
      {
        "criterion": "Precision (Assay imprecision)",
        "acceptance_criteria": "Typically less than a specified percentage (e.g., <10%, <15%).",
        "reported_performance": "<6% for AFP concentrations from 6.5 to 1680 ng/ml."
      },
      {
        "criterion": "Specificity",
        "acceptance_criteria": "No significant interference from potential biological substances, therapeutic drugs, or cross-reacting substances.",
        "reported_performance": "No significant interference."
      },
      {
        "criterion": "Analytical Sensitivity (Lowest detectable level)",
        "acceptance_criteria": "A specific low concentration value that is distinguishable from zero with a high confidence level.",
        "reported_performance": "0.5 ng/ml (distinguishable from zero with 95% confidence)."
      }
    ],
    "sample_size_test_set_and_data_provenance": {
      "correlation_study": {
        "sample_size": "170 samples",
        "data_provenance": "Not specified (retrospective or prospective, country of origin not mentioned)."
      },
      "expected_range_study": {
        "sample_size": "177 apparently healthy males and females",
        "data_provenance": "Not specified (retrospective or prospective, country of origin not mentioned)."
      },
      "monitoring_data_study": {
        "sample_size": "Longitudinal samples from previously diagnosed nonseminomatous testicular cancer patients (number not specified)",
        "data_provenance": "Not specified (retrospective or prospective, country of origin not mentioned)."
      },
      "recovery_studies": {
        "sample_size": "Not specified (number of human serum samples or spiked samples)",
        "data_provenance": "Not specified."
      },
      "precision_study": {
        "sample_size": "Not specified (number of samples tested for precision)",
        "data_provenance": "Not specified."
      },
      "specificity_study": {
        "sample_size": "Not specified (number of substances/drugs tested)",
        "data_provenance": "Not specified."
      },
      "analytical_sensitivity_study": {
        "sample_size": "Not specified",
        "data_provenance": "Not specified."
      }
    },
    "ground_truth_experts_test_set": {
      "correlation_monitoring_expected_range": "Not applicable, as these studies primarily compared measurements against a predicate device or established reference ranges, not against a new 'ground truth' established by experts in the context of image analysis, for example.",
      "qualifications": "Not applicable."
    },
    "adjudication_method_test_set": "Not applicable, as this is a quantitative immunoassay and not reliant on expert review of ambiguous cases.",
    "mrmc_comparative_effectiveness_study": "No, this is an in-vitro diagnostic device for quantitative measurement of alpha-fetoprotein (AFP) and not an imaging device or algorithm requiring human reader interpretation or assistance. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study with AI assistance is not relevant.",
    "standalone_performance_study": "Yes, all the described studies (correlation, expected range, monitoring data, recovery, precision, specificity, analytical sensitivity) demonstrate the standalone performance of the ACCESS® AFP Immunoassay. The assay directly measures AFP levels in serum.",
    "type_of_ground_truth_used": {
      "correlation_study": "The Abbott IMx AFP assay (predicate device) served as the reference for comparison.",
      "expected_range_study": "Statistical distribution of AFP values in an 'apparently healthy' population.",
      "monitoring_data_study": "Abbott IMx AFP assay results and 'concurrent clinical assessment' provided the reference for concordance.",
      "recovery_precision_specificity_analytical_sensitivity": "Defined analytical standards, known spiked concentrations, and reference materials were used."
    },
    "sample_size_training_set": "Not applicable, as this is a chemical immunoassay, not a machine learning model that requires a training set in the conventional sense. The 'training' for the assay involves internal calibration and reagent optimization by the manufacturer.",
    "ground_truth_training_set_establishment": "Not applicable for the reasons stated above. The immunoassay itself is based on chemical reactions and detection, not a learned algorithm from a training dataset."
  }
}

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