(232 days)
The Ig plex Celiac DGP Panel is an in vitro diagnostic test for the semi-quantitative detection of the IgA and IgG immunoglobulin classes of antibodies to deamidated gliadin peptide (DGP) and tissue transglutaminase (TG) in human serum. The test is intended for use in clinical laboratories as an aid in the disease in conjunction with other laboratory and clinical findings, and requires the sqid-X system.
The Ig plex Celiac DGP Panel is a consumable reagent kit. It is designed to run on the sqid-X system. The kit includes a microarray plate, reporter mix, standards, controls, sample diluents, wash buffer concentrates and a CD-ROM.
The assay detects the presences of the IgA and IgG classes of antibody, and the IgA and lgG classes of anti-tissue transglutaminase antibody. This is performed in an integrated fashion on the sqid-X system that reports all analytes simultaneously to aid in the diagnosis of celiac disease.
The system is a multiplex immunoassay analyzer that semi-automates the protocol of a specific lg plex assay from plate washing to reporting of all assay markers for each individual patient sample. The system combines manual liquid handling (samples and reagents) with automated steps for washing, scanning, data analyses and reporting. Results for each patient sample are obtained simultaneously for each of the four markers using the results from one well containing one aliquot of the patient's serum. Results are reported independently.
Here's a summary of the acceptance criteria and study findings for the Ig plex Celiac DGP Panel, based on the provided document:
1. Table of Acceptance Criteria & Reported Device Performance
The document does not explicitly state formal "acceptance criteria" in a go/no-go fashion with numerical targets for all performance metrics. However, it presents various performance results without indicating that they failed to meet any internal or regulatory thresholds. The following table summarizes what can be inferred as the expected performance based on the reported study results:
| Performance Metric | Acceptance Criteria (Inferred/Implied from Reported Performance) | Reported Device Performance (Ig plex Celiac DGP Panel) |
|---|---|---|
| Clinical Sensitivity | Acceptable sensitivity for each analyte | tTG IgA: 98.4% (95% CI: 97.3-99.5%) |
| tTG IgG: 46.9% (95% CI: 42.5-51.3%) | ||
| DGP IgA: 79.7% (95% CI: 76.1-83.2%) | ||
| DGP IgG: 89.1% (95% CI: 86.3-91.8%) | ||
| Clinical Specificity | Acceptable specificity for each analyte | tTG IgA: 100.0% (95% CI: 100.0-100.0%) |
| tTG IgG: 98.8% (95% CI: 98.1-99.5%) | ||
| DGP IgA: 99.2% (95% CI: 98.6-99.8%) | ||
| DGP IgG: 99.6% (95% CI: 99.2-100.0%) | ||
| Analytical Interference | Clinically acceptable recoveries (bias ≤15%) for specified interferents at given concentrations | Met for Bilirubin (0.15 mg/mL), Hemoglobin (5.00 mg/mL), Triglycerides (5.00 mg/mL), and Human IgG (0.50 mg/mL) across all analytes. |
| Method Agreement (Positive) | High positive agreement with predicate methods | tTG IgA: 100.0% (95% CI: 97.2-100.0%) |
| tTG IgG: 94.1% (95% CI: 84.1-98.0%) | ||
| DGP IgA: 93.3% (95% CI: 87.8-96.5%) | ||
| DGP IgG: 98.5% (95% CI: 94.6-99.6%) | ||
| Method Agreement (Negative) | High negative agreement with predicate methods | tTG IgA: 87.9% (95% CI: 82.5-91.8%) |
| tTG IgG: 84.6% (95% CI: 79.3-88.7%) | ||
| DGP IgA: 95.1% (95% CI: 90.9-97.4%) | ||
| DGP IgG: 90.3% (95% CI: 85.3-93.7%) | ||
| Method Agreement (Overall) | High overall agreement with predicate methods | tTG IgA: 92.9% (95% CI: 89.5-95.2%) |
| tTG IgG: 86.3% (95% CI: 81.8-89.9%) | ||
| DGP IgA: 94.3% (95% CI: 91.2-96.4%) | ||
| DGP IgG: 93.6% (95% CI: 90.4-95.7%) | ||
| Precision (Inter-assay, Lot-to-Lot, Instrument-to-Instrument) | Acceptable %CV values for various concentrations across different precision studies (generally |
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).