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The ARCHITECT B12 assay is a chemiluminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma on the ARCHITECT i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

The ARCHITECT B12 Calibrators are used to calibrate the ARCHITECT i System when the system is used for the quantitative determination of vitamin B12 in human serum and plasma using the ARCHITECT B12 Reagent Kit.

The ARCHITECT B12 Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum and plasma when using the ARCHITECT B12 Reagent Kit.

The ARCHITECT B12 assay is a two-step assay with an automated sample pretreatment, for determining the presence of B12 in human serum and plasma using chemiluminescent microparticle immunoassay (CMIA) technology with flexible assay protocols, referred to as Chemiflex.

The ARCHITECT B12 Reagent Kit consists of 100 (1 x 100) or 500 (1 x 500) tests. Each kit contains 1 bottle each of the following reagents: ARCHITECT B12 Microparticles, ARCHITECT B12 Conjugate, ARCHITECT B12 Assay Diluent, ARCHITECT B12 Pre-Treatment Reagent 1, ARCHITECT B12 Pre-Treatment Reagent 2, ARCHITECT B12 Pre-Treatment Reagent 3.

Each ARCHITECT B12 Calibrator Kit contains 6 Bottles (4 mL each) of ARCHITECT B12 Calibrators (1 bottle each of Calibrators A – F).

Each ARCHITECT B12 Control Kit contains 3 bottles (8 mL each) of ARCHITECT B12 Controls (1 bottle of low control, 1 bottle of medium control, and 1 bottle of high control).

{
  "1. A table of acceptance criteria and the reported device performance": {
    "Precision": {
      "Acceptance Criteria": "< 10% CV for total (within-laboratory) imprecision",
      "Reported Device Performance": "Low Panel (Lot 1, Inst 1): 6.7% CV; Low Panel (Lot 1, Inst 2): 6.3% CV; Medium Panel (Lot 1, Inst 1): 3.1% CV; Medium Panel (Lot 1, Inst 2): 3.1% CV; High Panel (Lot 1, Inst 1): 3.7% CV; High Panel (Lot 1, Inst 2): 3.1% CV; Low Panel (Lot 2, Inst 1): 6.0% CV; Low Panel (Lot 2, Inst 2): 6.9% CV; Medium Panel (Lot 2, Inst 1): 4.4% CV; Medium Panel (Lot 2, Inst 2): 3.1% CV; High Panel (Lot 2, Inst 1): 6.0% CV; High Panel (Lot 2, Inst 2): 3.3% CV. All values were ≤ 10% CV."
    },
    "Tube Type Equivalence (Lithium Heparin Plasma vs. Serum)": {
      "Acceptance Criteria": "Difference between tube types within +/-10.0% criteria (non-parametric two-sided 95% confidence limits around the median).",
      "Reported Device Performance": "Median % Difference: 3.3%; 95% CI: (2.2%, 4.7%). The limits fell entirely within the +/-10.0% criteria."
    }
  },
  "2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": {
    "Precision Study": {
      "Sample Size": "Low, Medium, and High lithium heparin plasma panels (number of distinct panels not specified, but tested in replicates).",
      "Data Provenance": "Not specified, but internal study conducted by Abbott Laboratories suggests prospective, lab-based data."
    },
    "Tube Type Study": {
      "Sample Size": "63 unique donors (each providing both plasma and serum samples).",
      "Data Provenance": "Not specified, but internal study conducted by Abbott Laboratories suggests prospective, lab-based data."
    }
  },
  "3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. This is an in-vitro diagnostic device for quantitative measurement, and performance is assessed by analytical studies (precision, method comparison) rather than subjective expert interpretation."
  },
  "4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. Ground truth for analytical studies is established through quantitative measurements against a reference method or predetermined statistical criteria, not through expert adjudication."
  },
  "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": "Not applicable. This is an in-vitro diagnostic device, not an AI-assisted diagnostic tool for human readers."
  },
  "6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Yes, the device performance described is standalone algorithm performance for the quantitative determination of vitamin B12."
  },
  "7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": {
    "Precision Study": "The ground truth for precision is the analytical variability of the device itself, measured by calculating standard deviation and coefficient of variation from repeated measurements of known analyte concentrations in control samples/panels.",
    "Tube Type Study": "The ground truth for tube type equivalence is the measurement obtained from the control tube type (plastic serum tubes), which serves as the reference for comparison with the evaluation tube type (lithium heparin plasma separator tubes)."
  },
  "8. The sample size for the training set": "Not applicable. The provided document describes validation studies for an in-vitro diagnostic assay, not machine learning model training."
  },
  "9. How the ground truth for the training set was established": "Not applicable. The provided document describes validation studies for an in-vitro diagnostic assay, not machine learning model training."
  }
}

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