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510(k) Data Aggregation
(68 days)
DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM
For the quantitative detection of RF IgM-class antibodies in human serum by indirect enzyme immunoassayas an aid in the diagnosis of rheumatoid arthritis (RA). This test kit can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
The Is-Rheumatoid Factor Test Kit System is an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of RF IgM-class in human serum.
Acceptance Criteria and Device Performance for Is-Rheumatoid Factor Test System
This document outlines the acceptance criteria and the results of studies demonstrating the performance of the Diamedix Is-Rheumatoid Factor Test System, an enzyme-linked immunosorbent assay (ELISA) for the detection and quantitation of IgM-class Rheumatoid Factor (RF) in human serum.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Is-Rheumatoid Factor Test System were established through comparative studies against another commercially available EIA kit and nephelometry, as well as an assessment of linearity, cross-reactivity, precision, and expected values in normal and clinical populations.
| Performance Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Relative Sensitivity | High agreement with predicate EIA device. | 100% (89/89) compared to another EIA kit (95% CI: 95.9-100.0%) |
| Relative Specificity | High agreement with predicate EIA device. | 100% (91/91) compared to another EIA kit (95% CI: 96.0-100.0%) |
| Overall Agreement | High agreement with predicate EIA device. | 100% (190/190) compared to another EIA kit (95% CI: 98.1-100.0%) |
| Correlation with Nephelometry | Strong positive correlation (e.g., r > 0.90). | Correlation Coefficient (r) = 0.9672 (95% CI: 0.9384 to 0.9826) for 40 samples. |
| Comparison with Latex Agglutination | Demonstrate at least comparable sensitivity/specificity to latex agglutination, or better given the quantitative nature of the device. | - Normal Sera (40 samples): Specificity 100% (40/40 Negative) for both Latex and Is-RF. |
- Clinical Sera (18 samples): Sensitivity 50% (9/18 Positive) for Latex; Sensitivity 100% (18/18 Positive) for Is-RF.
- Other Sera (13 samples): Latex 4/13 Positive; Is-RF 10/13 Positive. Higher sensitivity for Is-RF compared to Latex. |
| Linearity (WHO Standard) | High correlation coefficient (r) with serial dilutions. | Correlation Coefficient (r) = 0.9557. |
| Linearity (In-House Standard) | High correlation coefficient (r) with serial dilutions. | Correlation Coefficient (r) = 0.9634. |
| Lack of Cross-reactivity with other ANA | Minimal or no positive results from RF-negative samples containing other ANAs. | Out of 21 RF-negative samples with various ANAs (SSA, Sm, RNP, Scl-70, Jo-1, dsDNA, SSB), only one sample containing anti-SSB gave a very low positive result (21.2 IU/ml), all others were negative. This demonstrates minimal cross-reactivity. |
| Lack of Prozone/High-Dose Hook Effects | No evidence of prozone or high-dose hook effects across a range of RF concentrations. | No prozone or high-dose hook effects were evidenced in 8 sera (4 high concentrated, 2 mid-range, 2 negative) tested with serial dilutions. |
| Correlation of Manual and MAGO Plus Results | Strong positive correlation between manual and automated (MAGO Plus) testing. | Correlation Coefficient (r) = 0.9933 (95% CI: 0.9916 to 0.9946) for 303 normal and clinical serum samples. |
| Precision (Intra-assay and Inter-assay) | Acceptable coefficient of variation (%CV) for various RF levels, within generally accepted laboratory standards. | Manual: Intra-assay %CV generally
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