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Immunoassay for the in vitro quantitation of autoantibodies to thyroid stimulating hormone (TSH) receptor in human serum using a human thyroid stimulating monoclonal antibody. The anti-TSH receptor determination is used in the assessment of patients suspected of Graves' disease (autoimmune hyperthyroidism).

The electrochemiluminescence immunoassay "ECLIA" is intended for use on cobas e 601 immunoassay analyzers.

The Elecsys Anti-TSHR is used for the in vitro quantitative determination of autoantibodies to TSHR receptor in human serum using a human thyroid stimulating monoclonal antibody. It is intended for use on the cobas e 601 immunoassay analyzer. The cobas e family of analyzers uses electrochemiluminescence immunoassay "ECLIA" technology.

Here's an analysis of the provided text to extract the acceptance criteria and study information for the Elecsys Anti-TSHR device:

Acceptance Criteria and Device Performance for Elecsys Anti-TSHR

The Elecsys Anti-TSHR is an immunoassay for the in vitro quantitative determination of autoantibodies to the TSH receptor in human serum, used in the assessment of patients suspected of Graves' disease.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Precision (Repeatability & Intermediate Precision): 5 human serum samples (4 native, 1 spiked) and 2 controls (PC ThyroAB) were tested over 21 days with 2 replicates per run, 2 runs per day. (Total of 84 replicates per sample/control for repeatability and intermediate precision calculations).
• Lot-to-Lot Reproducibility: 5 human serum samples (4 native, 1 spiked) were tested with 2 replicates per run, 2 runs per day, for 3 reagent lots (n = 28 determinations per lot per sample, totaling 3x7x2x2 measurements over 3 lots for each sample).
• Analytical Sensitivity (LoB, LoD, LoQ):
  • LoB: Five blank samples with two replicates each per run, for 6 runs on ≥ three days, across three reagent lots. (Total 60 determinations for analyte-free samples).
  • LoD: Five low analyte samples with two replicates each per run, for 6 runs on ≥ three days, across three reagent lots. (60 replicates per sample per reagent lot).
  • LoQ: Samples tested across three reagent lots for 5 days, one run per day (25 replicates per sample per reagent lot).
• Linearity/Assay Reportable Range: Three high analyte human serum samples (serum pools) were diluted to create 14 concentrations (13 dilutions). Samples were measured in triplicate within a single run.
• Endogenous Interference (Biotin, Hemolysis, Bilirubin, Lipemia, Rheumatoid Factors): Not explicitly stated, but typically involves a few serum samples spiked with interferents and compared to unspiked controls. Each sample was spiked with the interfering substance, another aliquot was spiked with isotonic NaCl solution (dilution pool), and the interfering pool was diluted into the dilution pool (in 10% increments for some).
• Analytical Specificity/Cross-Reactivity: One native human serum sample pool with a low concentration of anti-TSHR was used.
• Exogenous Interferences (Drugs): Two human serum samples (native serum pools) were used.
• Method Comparison to Predicate:
  • Agreement: 260 clinical samples from the "intended use population".
  • Regression Analysis: A subset of 120 samples, evenly distributed across the measuring range, from the 260 collected samples.

Data Provenance:

• For the "Expected values" (Table 2), an external study used samples from 436 apparently healthy individuals, 210 patients with thyroid diseases without Graves' disease, and 102 patients with untreated Graves' disease.
• For the non-clinical performance evaluation, samples used were primarily "human serum pools" (native and spiked) and controls.
• For the Method Comparison, "clinical samples from the intended use population" were used.

The document does not explicitly state the country of origin or whether the data was retrospective or prospective beyond referring to "clinical samples" and an "external study."

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

This document describes an in vitro diagnostic immunoassay. The concept of "experts establishing ground truth for a test set" as typically understood in AI/imaging studies (e.g., radiologists reviewing images) is not directly applicable here. The "ground truth" for an immunoassay is typically established by reference methods, clinical diagnosis, or by defining specific concentrations for spiked samples or control materials.

For the "Expected Values" in Table 2, an external study was used where an "optimal cutoff of 1.75 IU/L was determined" based on diagnoses of apparently healthy individuals, those with thyroid diseases without Graves', and those with untreated Graves' disease. This implies a clinical diagnostic ground truth, but not direct "expert adjudication" in the sense of multiple experts assigning labels to individual cases for comparison.

4. Adjudication Method for the Test Set:

Not applicable in the context of an immunoassay performance study as described. Clinical diagnoses or reference assays serve as the "ground truth" rather than expert adjudication of individual test cases.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging interpretation devices involving human readers, not for an automated immunoassay such as the Elecsys Anti-TSHR.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

Yes, the studies described are all standalone performance evaluations of the Elecsys Anti-TSHR device itself. This device is an automated immunoassay system that provides quantitative results without human interpretation in the loop as part of its primary function. Its performance characteristics (precision, sensitivity, linearity, interference, method comparison) are evaluated directly.

7. The Type of Ground Truth Used:

• Clinical Diagnosis/Disease State: For "Expected Values" (Sensitivity and Specificity), the ground truth was based on patient cohorts: apparently healthy individuals, patients with thyroid diseases (without Graves'), and patients with untreated Graves' disease.
• Reference Methods/Known Concentrations: For analytical performance studies (Precision, Analytical Sensitivity, Linearity, Interference, Cross-Reactivity), the ground truth was established by:
  • Using predefined control materials with known values.
  • Using native human serum pools.
  • Spiking samples with known concentrations of analyte or interfering substances.
  • Comparison against a predicate device (Elecsys Anti-TSHR Immunoassay K080092) for method comparison.

8. The Sample Size for the Training Set:

The document describes performance evaluation studies, not the development or training of an AI algorithm. Therefore, there is no "training set" in the context of artificial intelligence or machine learning. The studies described are for validation and verification of the device's performance characteristics.

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

As there is no "training set" for an AI model mentioned in the context of this immunoassay, this question is not applicable. The device's underlying principles are based on electrochemiluminescence immunoassay (ECLIA) technology, not machine learning that requires a training set.

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