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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 (< 0.1%) are added as preservatives.
One (1) 5 mL vial of Conjugate, containing phycoerythrin conjugated murine monoclonal anti-human IgA or IgG and phycoerythrin conjugated sheep anti-human FXIII in MOPS (3-N-Morpholino] propanesulfonic acid) buffer supplemented with bovine protein stabilizers. ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) are added as preservatives.
One (1) 10 mL vial of Sample Diluent, containing bovine and murine protein stabilizers in triethanolamine buffer. ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) are added as preservatives.

BioPlex 2200 Celiac IgA and IgG Calibrator Sets contain nine (9) 0.5 mL vials of human antibodies to tTG and DGP in a buffer supplemented with protein stabilizer (porcine for IgA and porcine/human for IgG) with ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives.

BioPlex 2200 Celiac IgA and IgG Control Sets contain four (4) 1.5 mL vials of Positive Controls of human antibodies to tTG or DGP and two vials of Negative Controls in a human serum matrix made from defibrinated plasma; and, in a human serum matrix made from defibrinated plasma with ProClin 300 (≤ 0.3%), sodium benzoate (≤ 0.1%) and sodium azide (< 0.1%) as preservatives.

Additional materials required but not supplied include BioPlex 2200 Sheath Fluid containing Phosphate Buffered Saline (PBS) with ProClin 300 (<0.03%), and sodium azide (<0.1%) as preservatives; and BioPlex 2200 Wash Solution containing Phosphate Buffered Saline (PBS) and Tween 20 with ProClin 300 (≤0.03%) and sodium azide (<0.1%) as preservatives.

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

2. Sample Size Used for the Test Set and Data Provenance:

• 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).

• Linearity/Reportable Range: 3 low positive and 3 high positive patient serum samples for each antibody (anti-tTG IgA/IgG, anti-DGP IgA/IgG).

• 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.

• 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.

• 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.

• 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).

• Clinical Studies (Sensitivity and Specificity): 319 serum specimens, including 163 non-Celiac disease control patients and 156 diagnosed Celiac disease patients.

• Expected Values/Reference Range: 300 serum samples from apparently healthy donors (139 males, 161 females, age <1 to 101).

Data Provenance (Retrospective/Prospective, Country of Origin):
The document states that the method comparison study used "all retrospective patient serum samples." Similarly, the clinical sensitivity and specificity study involved clinical diagnosis of Celiac patients and non-Celiac controls. For cross-reactivity and expected values, these also appear to be retrospective collections of patient/donor samples. There is no explicit mention of the country of origin for the data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not explicitly state the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience") for establishing the ground truth.

For the "clinical diagnosis," it refers to "patients previously diagnosed with celiac disease" and "non-Celiac disease control patients." This implies that the diagnosis was established through standard clinical practice by relevant healthcare professionals (e.g., gastroenterologists) using a combination of clinical findings, biopsy, and other diagnostic tests, which is a common approach for establishing ground truth in diagnostic assay validation. The specific expertise used for these previous diagnoses is not detailed.

4. Adjudication Method for the Test Set:

The document does not describe a specific adjudication method like "2+1" or "3+1" for determining ground truth in the patient samples. The ground truth appears to be based on "clinical diagnosis" or categorization of "apparently healthy donors" and specific disease states. While this is a form of ground truth, it wasn't established through a formal adjudication process (e.g., blinded review by multiple experts with a tie-breaker).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance:

This question is not applicable. The device is an in vitro diagnostic immunoassay for semi-quantitative detection of antibodies, not an imaging device or AI system that assists human "readers" in interpreting images. Therefore, an MRMC study or an assessment of human reader improvement with AI assistance is not relevant to this product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This question is not directly applicable in the typical sense of AI algorithms. The BioPlex® 2200 system performs the assay and provides numerical results (U/mL) without human interpretive input for the final measurement. The "standalone" performance is essentially the output of the instrument-reagent system. The "clinical sensitivity and specificity" study (Section 3) represents the standalone performance of the assay compared to clinical diagnosis.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

The ground truth used for performance evaluation can be categorized as:

• Clinical Diagnosis: For the clinical sensitivity and specificity studies, the ground truth for "Celiac disease patients" and "non-Celiac disease control patients" was based on their clinical diagnosis. This typically involves a combination of symptoms, serology, and duodenal biopsy.
• Predicate Device Results: For the method comparison study, the predicate immunoassay results served as the comparison point for agreement. While not a "true" ground truth in a clinical sense, it acts as a reference for establishing substantial equivalence.
• Disease State Classification: For cross-reactivity studies, samples were from individuals with "known disease states."
• Apparently Healthy Donors: For establishing expected values and confirming cut-offs, samples were from "apparently healthy donors."

8. The Sample Size for the Training Set:

The document does not explicitly describe a separate "training set" in the context of machine learning (AI). This is a diagnostic immunoassay system. The development of the assay (e.g., antigen selection, calibrator assignment, and establishment of linearity) inherently involves a "training" or development phase, but it's not described as a discrete "training set" in the AI sense.

However, the "Assay cut-off" section mentions that the cut-off values were determined using "123 samples from patients diagnosed with celiac disease and 112 from non-celiac or other rheumatic disease control donors." This set of samples was used to perform ROC analysis to establish the cut-off, which is a critical parameter for classifying results and could be considered analogous to a development or "training" set for defining the decision boundary of the assay. This was then "confirmed by testing 298 samples from apparently healthy donors."

9. How the Ground Truth for the Training Set Was Established:

As discussed in point 8, the "training set" for establishing the assay cut-off involved:

• Clinical Diagnosis: For the 123 celiac disease patients and 112 non-celiac/rheumatic disease control donors, the ground truth was their established clinical diagnosis. This implies diagnosis by medical professionals using standard diagnostic criteria.
• Healthy Status: For the 298 apparently healthy donors, the ground truth was their healthy status, likely determined through health screenings or self-reporting.

The specific "how" (e.g., detailed diagnostic reports, biopsy confirmation) and the expertise involved in these diagnoses are not explicitly detailed in the document beyond "clinically diagnosed."

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