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The EUROIMMUN IFA 40: HEp-20-10 is an indirect immunofluorescence antibody test for the qualitative or semi-quantitative detection of antibodies against cell nuclei (ANA) in human serum. This test system is used as an aid in the diagnosis of systemic rheumatic diseases in conjunction with other laboratory and clinical findings.

The test system consists of BIOCHIPs coated with HEp-20-10 cells. It includes a fluorescein-labeled goat anti-human IgG, a positive and negative control, salt for PBS, Tween 20, embedding medium, cover glasses and instruction booklet. Reagent trays for the TITERPLANE technique are required but ordered separately.

Here's a breakdown of the acceptance criteria and study information for the EUROIMMUN IFA 40: HEp-20-10 device, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample Size and Data Provenance

• Qualitative Comparison Study (Method comparison with predicate device):
  • Test Set Sample Size: 200 blinded prospective samples.
  • Data Provenance: Department of Clinical Pathology & Laboratory Medicine at the University of Pennsylvania (USA). Samples obtained from patients sent for routine ANA screening.
• Semi-Quantitative/Quantitative Comparison Study (Method comparison with predicate device):
  • Test Set Sample Size: 156 blinded prospective samples.
  • Data Provenance: Samples obtained from patients sent for routine ANA screening (location not explicitly stated but implied to be the same clinical setting as the qualitative study given the continuous description and similar sample acquisition method).
• Assay Cut-off Verification:
  • Test Set Sample Size: 138 samples.
  • Data Provenance: EUROIMMUN US Inc. laboratory (USA). Serum samples sent in for antibody testing, collected in sequential order for two days.
• Expected Values/Reference Range Study:
  • Test Set Sample Size: 200 sera from normal healthy adult blood donors.
  • Data Provenance: University hospital Lübeck, Germany.
• Analytical Performance Studies (Precision/Reproducibility, Linearity, Analytical Specificity, Interfering Substances):
  • Data Provenance: All performed at EUROIMMUN Medizinische Labordiagnostika AG, Lübeck, Germany, unless stated otherwise. The Inter-Observer Reproducibility Study was performed in a US Laboratory setting.
  • Sample Sizes: Vary per study (e.g., 10-fold repeated measurements for Intra-Assay, 20 repeated for Inter-Assay, 6 for Inter-Lot, 14 positive and 1 negative for Semi-quantitative Reproducibility, 6 for Linearity, 20 for Interfering substances). Specific numbers for each analytical study are provided in the "Performance Characteristics" section.

3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts

• Qualitative and Semi-Quantitative/Quantitative Comparison Studies:
  • Number of Experts: Two primary technicians, with a third decisive technician in case of discrepancies.
  • Qualifications: "Technicians" are mentioned. No specific background (e.g., years of experience, specific certifications) is provided.
• Analytical Performance Studies (e.g., Reproducibility, Linearity, Analytical Specificity, Interfering Substances):
  • Generally, the evaluation was performed by "the same technician" or "two different technicians," with a third technician for resolution in Inter-Observer Reproducibility. No specific qualifications are detailed.
• Assay Cut-off Verification & Expected Values/Reference Range Studies:
  • "As per the American College of Rheumatology" is cited for an expected prevalence range, indicating reliance on established medical guidelines/expert consensus for context, but not for direct ground truth labeling of individual samples in these specific studies. Samples were tested as per instructions for use by technicians.

4. Adjudication method for the test set

• Qualitative and Semi-Quantitative/Quantitative Comparison Studies:
  • Adjudication Method: "Visual fluorescence microscopy evaluation was performed by two different technicians independently. In case of a discrepant result a 3rd technician was decisive." This is a 2+1 adjudication method.
• Inter-Observer Reproducibility:
  • Adjudication Method: "separate independent reading of the Inter-Assay slides by a 2nd technician. In case of discrepancies a 3th technician would have been decisive." This is also a 2+1 adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance.

• No, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers improving with AI vs. without AI assistance was not performed. This device is an in-vitro diagnostic test kit that relies on human microscopy reading, not an AI-assisted diagnostic tool for image interpretation. The comparison studies were between the new device and a predicate device, both relying on human visual interpretation.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• No, a standalone algorithm-only performance study was not done. The device is an IFA test system that requires human visual interpretation via a fluorescent microscope.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Qualitative and Semi-Quantitative/Quantitative Comparison Studies: The ground truth was established by the predicate device (ImmunoConcepts® HEp-2000 ANA-Ro IFA), interpreted by technicians with a 2+1 adjudication. Discrepancies were sometimes confirmed using "FDA cleared assays" (e.g., blot tests), which serve as a higher-level reference standard.
• Analytical Specificity (Cross-reactivity): The CDC Centers for Disease Control and Prevention reference panel (characterized by the CDC) was used as ground truth.
• Assay Cut-off Verification & Expected Values/Reference Range Studies: The ground truth for individual samples was their status as positive or negative based on the device's interpretation at a specific dilution. The reference range and prevalence context were established by comparing against published ranges from the American College of Rheumatology.
• Precision/Reproducibility, Linearity, Interfering Substances: Ground truth implicitly involved the expected behavior of the samples (e.g., 0-4+ intensity, specific patterns, decreasing intensity with dilution) as evaluated by trained technicians.

8. The sample size for the training set

• The document does not mention a training set, as this is an in-vitro diagnostic test kit that is read visually by technicians, not a machine learning or AI-based diagnostic tool that would typically require a training set.

9. How the ground truth for the training set was established

• Not applicable, as no training set for an algorithm was mentioned or used.

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