(69 days)
The TPO IgG kit is an Enzyme-Linked Immunosorbent Assay (ELISA) For the qualitative detection and quantitation of antibodies against the thyroid peroxidase antigen in serum as an aid in the diagnosis of thyroid autoimmune disease. The test can be performed either manually or in conjunction with the Mago Plus automated EIA processor.
The & TPO IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the detection of IgG to thyroid peroxidase in human serum.
Acceptance Criteria and Study for Is-anti-TPO IgG ELISA Test Kit
This document describes the acceptance criteria and the studies performed to demonstrate the safety and effectiveness of the Is-anti-TPO IgG ELISA Kit.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Relative Sensitivity | Not explicitly stated, but compared to a commercially available ELISA kit. | 100% (71/71) when equivocal results are excluded. |
| Relative Specificity | Not explicitly stated, but compared to a commercially available ELISA kit. | 97.1% (167/172) when equivocal results are excluded. |
| Overall Agreement | Not explicitly stated, but compared to a commercially available ELISA kit. | 97.9% (238/243) when equivocal results are excluded. |
| Clinical Specificity (Normals) | Not explicitly stated, but assessed in normal patient group. | 91.4% (160/175) with a 95% CI of 86.3-95.1%. |
| Clinical Sensitivity (Grave's Disease) | Not explicitly stated, but assessed in Grave's Disease patient group. | 64.3% (9/14) with a 95% CI of 35.1-87.2%. |
| Clinical Sensitivity (Hashimoto's Disease) | Not explicitly stated, but assessed in Hashimoto's Disease patient group. | 75.0% (12/16) with a 95% CI of 47.6-92.7%. |
| Intra-Assay Precision (CV%) | Desired to be low for consistent results within a single assay run. | Site #1 (Manual): Range from 4.96% to 14.37% for positive sera, and 36.15% to 316.23% for negative sera (higher CV% for very low values is expected). |
| Site #2 (Manual): Range from 6.31% to 19.84% for positive sera, and 6.35% to 15.90% for negative sera. | ||
| MAGO Plus: Range from 8.42% to 20.61% for all sera. | ||
| Interassay Precision (CV%) | Desired to be low for consistent results across different assay runs. | Site #1 (Manual): Range from 5.89% to 11.04% for positive sera, and 41.92% to 161.76% for negative sera. |
| Site #2 (Manual): Range from 8.29% to 21.47% for positive sera, and 43.97% to 55.73% for negative sera. | ||
| MAGO Plus: Range from 11.43% to 48.32% for all sera. | ||
| Correlation of Manual and MAGO Plus Results | Demonstrate equivalence between manual and automated methods. | Pearson Correlation Coefficient of 0.977 (indicated good correlation). |
2. Sample Size and Data Provenance (Test Set)
- Relative Sensitivity and Specificity Study: 255 frozen retrospective sera.
- Clinical Sensitivity and Specificity Study: 207 frozen retrospective, characterized sera.
- Precision Study: 4 positive sera and 2 negative sera, each assayed 10 times in 3 different runs at 2 different sites. For MAGO Plus precision, 6 sera were assayed 10 times each in 3 different runs.
- Correlation of Manual and MAGO Plus Results: 104 serum samples.
Data Provenance: All data appears to be retrospective. The country of origin of the data is not explicitly stated in the provided text, but given the context of a US regulatory submission, it is likely the data was collected in the USA or a region with comparable clinical practices.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
The document does not explicitly state the number of experts used to establish the ground truth for the test set, nor their specific qualifications (e.g., radiologist with X years of experience).
- For the "Relative Sensitivity and Specificity" study, a "commercially available ELISA kit for TPO antibodies" was used as the comparator, implying its results served as the reference for ground truth in that comparison.
- For the "Clinical Sensitivity and Specificity" study, "characterized sera" were used. This suggests that the ground truth for these samples (e.g., normal, Grave's Disease, Hashimoto's Disease) was previously established through clinical diagnosis, but the method and expert involvement are not detailed.
4. Adjudication Method (Test Set)
The document does not describe an adjudication method for the test set, such as 2+1 or 3+1. The ground truth appears to be based on results from a comparative device or pre-characterized clinical diagnoses.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The device is an in-vitro diagnostic (ELISA kit), not an imaging or AI-assisted diagnostic tool that typically involves human readers. Therefore, the concept of human readers improving with or without AI assistance is not applicable here.
6. Standalone Performance Study
Yes, a standalone performance study was conducted. The "Relative Sensitivity and Specificity" and "Clinical Sensitivity and Specificity" sections, along with the "Precision" studies, evaluate the performance of the "Is-anti-TPO IgG Test Kit" as a standalone device. The correlation study with the MAGO Plus demonstrates the performance of the kit both manually and when integrated with an automated processor, but these are still evaluations of the algorithm/kit itself.
7. Type of Ground Truth Used
- Relative Sensitivity and Specificity Study: The "ground truth" was established by the results of a commercially available ELISA kit for TPO antibodies. This is a form of comparative reference standard.
- Clinical Sensitivity and Specificity Study: The "ground truth" was based on characterized clinical diagnoses (Normals, Grave's Disease, Hashimoto's Disease). This can be categorized as clinical diagnosis/outcomes data, although the specific methods of characterization are not detailed.
8. Sample Size for the Training Set
The document does not mention a "training set" or "validation set" in the context of device development. The studies described are performance evaluations of the final device. This type of in-vitro diagnostic development typically focuses on analytical and clinical performance studies rather than machine learning model training.
9. How Ground Truth for Training Set Was Established
As no training set is described, the method for establishing its ground truth is not applicable or provided.
§ 866.5870 Thyroid autoantibody immunological test system.
(a)
Identification. A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.(b)
Classification. Class II (performance standards).