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The INCSTAR Toxoplasma IgM Capture ELISA kit contains instructions and materials for the qualitative detection of IgM antibodies to Toxoplasma gondii in human serum by reverse capture enzyme-linked immunosorbent assay (ELISA) technique. When performed according to instructions, the Toxoplasma IgM Capture ELISA test can be used as an aid in the diagnosis of current or recent active Toxoplasma gondii infection. This product is not FDA cleared for use in testing (i.e., screening) blood or plasma donors.

The INCSTAR Toxoplasma IgM Capture ELISA Kit utilizes the enzyme-linked immunosorbent assay (ELISA) based on the antibody capture technique. Diluted patient serum is incubated with monoclonal mouse antibody against human IgM (u chain specific) bound to the solid surface of the microtiter well. : Patient IgM is "captured" by the surface bound antibody. The presence of patient anti-Toxoplasma IgM antibodies are then "detected" and bound by Toxoplasma antigen which is linked to an anti-Toxoplasma antibody conjugated to horseradish peroxidase. Bound horseradish peroxidase is reacted with chromogen, resulting in color development. The absorbance of the solution, measured at 450 nm / 630 nm, is directly proportional to the concentration of IgM to Toxoplasma antigen present in the reaction solution.

{
  "1": {
    "table_of_acceptance_criteria_and_reported_device_performance": {
      "Acceptance Criteria": [
        "Relative sensitivity: 91% to 99% (95% confidence intervals)",
        "Relative specificity: 99% to 100% (95% confidence intervals)",
        "Overall agreement: 97% to 100% (95% confidence intervals)"
      ],
      "Reported Device Performance": [
        "Relative sensitivity: 91% to 99%",
        "Relative specificity: 99% to 100%",
        "Overall agreement: 97% to 100%"
      ]
    },
    "sample_size_test_set_data_provenance": "406 serum samples from 375 individuals. The data provenance is not explicitly stated as retrospective or prospective, nor the country of origin, but it represents a \"mixed population of healthy donors, transplant patients, immunocompromised hosts, pregnant women, Toxoplasma proven individuals, and patients having various other illnesses.\"",
    "number_of_experts_ground_truth_test_set_qualifications": "Not applicable. The ground truth for the test set was established by comparison to a cleared predicate device (BioWhittaker TOXOCAP-M ELISA kit), not by expert consensus.",
    "adjudication_method_test_set": "Not applicable. The ground truth for the test set was established by comparison to a cleared predicate device, not through expert adjudication.",
    "multi_reader_multi_case_comparative_effectiveness_study": "No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is a diagnostic kit, not an AI-assisted interpretation system for human readers.",
    "standalone_algorithm_only_performance": "Yes, a standalone performance study was done. The study compares the performance of the INCSTAR Toxoplasma IgM Capture ELISA Kit to a predicate device, which inherently evaluates the algorithm (kit) on its own.",
    "type_of_ground_truth_used": "Comparative ground truth based on a predicate device (BioWhittaker TOXOCAP-M ELISA kit).",
    "sample_size_training_set": "Not applicable. The document describes a diagnostic kit, and the performance study is a validation study comparing it to a predicate device, not a study involving iterative training and testing of a machine learning model. Therefore, a distinct 'training set' in the machine learning sense is not mentioned or relevant to the described study.",
    "how_ground_truth_for_training_set_established": "Not applicable, as there is no training set described in the context of a machine learning model."
  }
}

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