(138 days)
The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma. The assay is used to detect antibodies in a single specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. The analysis should be performed by trained laboratory professionals.
The EDIA™ anti-CCP test kit is an enzyme-linked immunosorbent assay (ELISA) for detection and semi-quantitation of IgG antibodies to Cyclic Citrullinated Peptides (CCP) in human sera and plasma. The assay is used to detect antibodies in a single specimen. The results of the assay are to be used as an aid to the diagnosis of Rheumatoid Arthritis (RA), in conjunction with other laboratory and clinical findings. Trained laboratory professionals should perform the analysis. "For in vitro diagnostic use".
The wells are coated with Cyclic Citrullinated Peptides. During the first incubation, specific antibodies in diluted serum, will bind to the antigen coating.
The wells are then washed to remove unbound antibodies and other components. A conjugate of alkaline phosphatase labelled antibodies to human IgG binds to the antibodies in the wells in this second incubation.
After a further washing step, detection of specific antibodies is obtained by incubation with substrate solution. The amount of bound antibodies correlates to the colour intensity and is measured in terms of absorbance (optical density (OD)). The absorbance is then calculated against a calibrator curve and the results are given in arbitrary units.
Here's a breakdown of the acceptance criteria and study details for the EDIA™ anti-CCP kit, based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are not explicitly stated as strict pass/fail thresholds in the provided document. Instead, the study aims to demonstrate substantial equivalence to a predicate device and establish clinical performance characteristics. The reported device performance is as follows:
| Performance Metric | Acceptance Criteria (Implied / Predicate Comparison) | Reported Device Performance |
|---|---|---|
| Predicate Device Comparison | ||
| Positive Percent Agreement | Substantial equivalence to Immunoscan RA anti-CCP (e.g., high agreement). | 98.4% (95% CI: 96.4 - 99.5%) |
| Negative Percent Agreement | Substantial equivalence to Immunoscan RA anti-CCP (e.g., high agreement). | 99.4% (95% CI: 98.0 - 99.9%) |
| Overall Percent Agreement | Substantial equivalence to Immunoscan RA anti-CCP (e.g., high agreement). | 99.0% (95% CI: 97.9 - 99.6%) |
| Linear Correlation (EDIA vs. Immunoscan RA) | Strong positive linear correlation expected. | R-squared = 0.8886 |
| Clinical Performance | ||
| Clinical Sensitivity (RA patients) | Adequate sensitivity for aiding in RA diagnosis (no explicit numerical target, but typically >70% for such markers). | 76.2% (95% CI: 72.1-80.3) |
| Clinical Specificity (Healthy Blood Donors) | High specificity to differentiate from healthy individuals and other diseases (no explicit numerical target, but typically >90%). | 99.2% (95% CI: 97.3 - 99.9%) |
| Clinical Specificity (Non-RA Diseased) | High specificity to differentiate from various non-RA conditions (no explicit numerical target, but ideally >90% for most). | Ranged from 80% (Chlamydia) to 100% (many conditions) |
| Total Clinical Specificity (Non-RA) | Overall high specificity across non-RA conditions. | 98.6% |
| Analytical Performance | ||
| Intra-assay Precision (% CV) | Low variability (e.g., |
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).