(53 days)
The Access® Thyroglobulin Antibody (TgAb) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of thyroglobulin antibody levels in human serum and plasma using the Access® Immunoassay Systems. The measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease, nontoxic goiter, and Graves' disease.
The Access Thyroglobulin Antibody reagents, Thyroglobulin Antibody calibrators, and the Access Immunoassay Analyzer comprise the Access Immunoassay System for the quantitative determination of thyroglobulin antibody in human serum and plasma.
Here's a breakdown of the acceptance criteria and study information for the Access® Thyroglobulin Antibody assay, based on the provided text:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Analytical Specificity | No significant interference from potential sample contaminants (total protein, bilirubin, hemoglobin, and triglycerides). Only one discrepancy found between interpretations positive and negative when compared to the predicate device for autoimmune disease samples. |
| Analytical Sensitivity | Lowest detectable level: 1.5 IU/mL (at 95% confidence). An analytical sensitivity of 2.2 IU/mL will be used in labeling. |
| Dilution Recovery | Overall mean recovery: 95%. Individual mean sample recoveries: 90% to 100%. |
| Precision | Within-run imprecision: 3.99 to 5.04 % CV |
| Between-run imprecision: 1.95 to 4.66 % CV | |
| Total imprecision: 4.47 to 6.74 % CV (at levels between 34.1 and 1,693 IU/ml) | |
| Hook Effect | No hook effect demonstrated up to 350,000 IU/ml. |
| Relative Sensitivity vs. Predicate | 79.0% |
| Relative Specificity vs. Predicate | 87.6% |
| Method Comparison (Correlation with Predicate) | Correlation coefficient (r) = 0.816 |
| Slope (y) = 0.957 | |
| Intercept = -5.886 | |
| Reagent Stability | 56 days after opening. |
| Calibration Curve Stability | 56 days. |
Study Information
- Sample size used for the test set and the data provenance:
- Test Set Sample Size:
- Relative Sensitivity and Specificity: 296 serum samples (99 with Graves' disease, 97 with Hashimoto's disease, and 100 normals).
- Method Comparison: 276 samples (values ranging from approximately
- Test Set Sample Size:
§ 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).