(247 days)
The BioPlex 2200 Celiac IgA kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgA autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy). The BioPlex 2200 Celiac IgA kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Celiac IgG kit is an in vitro multiplex flow immunoassay intended for the semi-quantitative detection of IgG autoantibodies to deamidated gliadin peptide (DGP) and tissue Transglutaminase (tTG) in human serum. In conjunction with clinical findings and other diagnostic tests, the test system is used as an aid in the diagnosis of Celiac Disease (gluten-sensitive enteropathy). The BioPlex 2200 Celiac IgG kit is intended for use with the Bio-Rad BioPlex 2200 System.
The BioPlex 2200 Celiac IgA Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac IgA Reagent Pack.
The BioPlex 2200 Celiac IgG Calibrator Set is intended for the calibration of the BioPlex 2200 Celiac IgG Reagent Pack.
The BioPlex 2200 Celiac IgA Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Celiac IgA Reagent Pack in the clinical laboratory. The performance of the BioPlex Celiac IgA Control Set has not been established with any other antitissue Transglutaminase (tTG) and anti-Deamidated Gliadin Peptide IgA assays.
The BioPlex 2200 Celiac IgG Control Set is intended for use as an assayed quality control to monitor the overall performance of the BioPlex 2200 Instrument and BioPlex 2200 Celiac IgG Reagent Pack in the clinical laboratory. The performance of the BioPlex Celiac IgG Control Set has not been established with any other antitissue Transglutaminase (tTG) and anti-Deamidated Gliadin Peptide IgG assays.
BioPlex® 2200 Celiac IgA and IgG kits include the following components:
One (1) 10 mL vial of Bead Set, containing dyed beads coated with recombinant antigens; an Internal Standard bead (ISB), a Serum Verification bead (SVB) and IgA Verification Bead (AVB) (in Celiac IgA only), in MOPS (3-[N-Morpholino] propanesulfonic acid) buffer supplemented with Glycerol and protein stabilizer (bovine and porcine). ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (
Here's an analysis of the acceptance criteria and study findings for the BioPlex® 2200 Celiac IgA and IgG kits, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state numerical acceptance criteria in a dedicated section with pass/fail thresholds. Instead, it presents performance characteristics from various studies. For this table, I will present the reported performance, which implicitly serves as the evidence that the device meets acceptable levels for these metrics. The "Target Performance" column will reflect typical expectations for such assays or the performance shown by the predicate devices where applicable.
Performance Characteristics for BioPlex® 2200 Celiac IgA and IgG Kits
| Performance Metric | Specific Assay | Reported Device Performance (Mean %CV/Values) | Target Performance (Implicit/Predicate) |
|---|---|---|---|
| Precision/Reproducibility (CLSI EP5-A2, 20 days, n=80 per sample type) | Anti-tTG IgA | Total Precision: 7.5% - 10.9% CV | Within generally accepted ranges for immunoassays (typically LoD > LoB, and values should be analytically sound for the intended use. |
| Anti-DGP IgA | LoQ: 0.2 U/mL, LoD: 0.1 U/mL, LoB: 0.0 U/mL | ||
| Anti-tTG IgG | LoQ: 0.8 U/mL, LoD: 0.8 U/mL, LoB: 0.6 U/mL | ||
| Anti-DGP IgG | LoQ: 0.4 U/mL, LoD: 0.1 U/mL, LoB: 0.0 U/mL | ||
| Clinical Sensitivity | Anti-tTG IgA | 94.9% (148/156) (95% CI: 90.2 - 97.4%) | High sensitivity for aid in diagnosis of Celiac Disease. |
| Anti-DGP IgA | 87.2% (136/156) (95% CI: 81.0 - 91.5%) | ||
| Anti-tTG IgG | 44.2% (69/156) (95% CI: 36.7 - 52.1%) | ||
| Anti-DGP IgG | 84.6% (132/156) (95% CI: 78.1 - 89.4%) | ||
| Clinical Specificity | Anti-tTG IgA | 98.8% (160/162) (95% CI: 95.6 - 99.7%) | High specificity for aid in diagnosis of Celiac Disease. |
| Anti-DGP IgA | 96.9% (158/163) (95% CI: 93.0 - 98.7%) | ||
| Anti-tTG IgG | 95.7% (155/162) (95% CI: 91.4 - 97.9%) | ||
| Anti-DGP IgG | 96.9% (158/163) (95% CI: 93.0 - 98.7%) | ||
| Method Comparison (Predicate Device) | Anti-tTG IgA (Positive Agreement) | 96.4% (163/169) (95% CI: 92.5 - 98.4%) | High agreement with legally marketed predicate devices. |
| Anti-tTG IgA (Negative Agreement) | 100% (176/176) (95% CI: 97.9 - 100%) | ||
| Anti-tTG IgA (Total Agreement) | 98.3% (339/345) (95% CI: 96.3 - 99.2%) | ||
| Anti-DGP IgA (Positive Agreement) | 97.3% (144/148) (95% CI: 93.3 - 98.9%) | ||
| Anti-DGP IgA (Negative Agreement) | 93.4% (185/198) (95% CI: 89.1 - 96.1%) | ||
| Anti-DGP IgA (Total Agreement) | 95.1% (329/346) (95% CI: 92.3 - 96.9%) | ||
| Anti-tTG IgG (Positive Agreement) | 93.3% (56/60) (95% CI: 84.1-97.4%) | ||
| Anti-tTG IgG (Negative Agreement) | 87.4% (249/285) (95% CI: 83.0 - 90.7%) | ||
| Anti-tTG IgG (Total Agreement) | 88.4% (305/345) (95% CI: 84.6-91.4%) | ||
| Anti-DGP IgG (Positive Agreement) | 93.3% (140/150) (95% CI: 88.2 - 96.3%) | ||
| Anti-DGP IgG (Negative Agreement) | 91.3% (179/196) (95% CI: 86.6 - 94.5%) | ||
| Anti-DGP IgG (Total Agreement) | 92.2% (319/346) (95% CI: 88.9 - 94.6%) |
2. Sample Size Used for the Test Set and Data Provenance:
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Precision/Reproducibility:
- CLSI EP5-A2: 24 samples (serum panel consisting of samples spanning the measuring range), tested in replicate twice daily over 20 days (n=80 replicates per sample type).
- CLSI EP15-A2: 12 samples (serum panel consisting of samples spanning the measuring range), tested in 4 replicates per run, one run per day over 5 days (n=20 replicates per sample type).
- Lot-to-lot Reproducibility: Unspecified number of serum samples covering the assay range, tested with three reagent lots on three instruments, 10 replicates for two runs per lot (60 points per sample ID for calculation).
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Linearity/Reportable Range: 3 low positive and 3 high positive patient serum samples for each antibody (anti-tTG IgA/IgG, anti-DGP IgA/IgG).
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Analytical Specificity (Interference): Test substances (e.g., Hemolysate, Bilirubin, Triglycerides). No specific number of samples given for the interference study, but the substances were tested at specified concentrations.
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Analytical Specificity (Cross-Reactivity): 244 samples from individuals with various disease states (e.g., Chronic Active Hepatitis, Crohn's Disease, Diabetes Mellitus Type 1, Rheumatoid Arthritis). The number of samples for each disease state ranged from 6 to 30.
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Assay Cut-off Determination: 123 samples from patients with diagnosed celiac disease and 112 from non-celiac/rheumatic disease control donors. Confirmed with 298 samples from apparently healthy donors.
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Method Comparison with Predicate Device:
- All samples: 156 patients with celiac disease, 163 patients with other rheumatic or non-CD disease control, 11 celiac IgA deficient patients, and 16 Dermatitis Herpetiformis (DH) patients. Total: 346-347 samples (1 sample excluded in some analyses).
- Samples within measuring range (and 10% diluted): Varying totals per assay, e.g., anti-tTG IgA (211), anti-DGP IgA (310), anti-tTG IgG (288), anti-DGP IgG (248).
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Clinical Studies (Sensitivity and Specificity): 319 serum specimens, including 163 non-Celiac disease control patients and 156 diagnosed Celiac disease patients.
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Expected Values/Reference Range: 300 serum samples from apparently healthy donors (139 males, 161 females, age
§ 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).