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The IMMULITE® 2000 Vancomycin assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

The IMMULITE® 2500 Vancomycin assay is intended for use as follows: For in vitro diagnostic use with the IMMULITE 2500 Analyzer - for the quantitative measurement of vancomycin in serum and plasma (EDTA or heparinized), as an aid in monitoring the therapeutic administration of this antibiotic.

The IMMULITE 2000, IMMULITE 2500 Vancomycin assay is a solid phase competitive chemiluminescent enzyme immunoassay. The solid phase (bead) is coated with ligandlabeled vancomycin. The reagent contains alkaline phosphatase (bovine calf intestine) conjugated to monoclonal murine antivancomycin in the patient sample competes with the ligand-labeled solid phase for vancomycin binding sites on the monoclonal murine anti-vancomycin enzyme conjugate. The excess sample and reagent are removed by a centrifugal wash. Finally, chemiluminescent substrate is added to the bead and signal is generated in proportion to the bound enzyme. The assay includes an automatic on-board predilution of 1/20 prior to immunoreaction. Immunoreaction incubation time is 30 minutes. The sample volume required is 10 µL for the test and 250 uL dead volume. The sample types are serum and plasma (heparin or EDTA).

{
  "acceptance_criteria_study": {
    "1_acceptance_criteria_table": [
      {
        "Criterion": "Reportable Range",
        "Acceptance Criteria": "Not explicitly stated as a separate acceptance criterion, but the reported range is 3.0 µg/mL – 50 µg/mL.",
        "Reported Device Performance": "3.0 µg/mL – 50 µg/mL for both IMMULITE 2000 and IMMULITE 2500 Vancomycin assays."
      },
      {
        "Criterion": "Limit of Blank (LoB)",
        "Acceptance Criteria": "The highest value expected to be seen in a series of results for samples that contain no analyte, based on CLSI guideline EP17-A. Computed as mean CPS - 1.65 * total SDcps, then converted to vancomycin dose.",
        "Reported Device Performance": "0.4 µg/mL for both IMMULITE 2000 and IMMULITE 2500."
      },
      {
        "Criterion": "Limit of Detection (LoD)",
        "Acceptance Criteria": "The actual concentration at which an observed test result is likely to exceed the Limit of Blank (LoB) and may therefore be declared as detected, based on CLSI guideline EP17-A. Formula: LoD = LoB + 1.65 * SD.",
        "Reported Device Performance": "0.9 µg/mL for both IMMULITE 2000 and IMMULITE 2500."
      },
      {
        "Criterion": "Precision (IMMULITE 2000)",
        "Acceptance Criteria": "Intra- and inter-assay CV% over the range of approximately 5 to 47 µg/mL should not be greater than 10.2% and 6.8%, respectively.",
        "Reported Device Performance": "Max statistics across 3 lots show intra-assay CV% not greater than 10.2% and inter-assay CV% not greater than 6.8% over the range of approximately 5 to 47 µg/mL."
      },
      {
        "Criterion": "Precision (IMMULITE 2500)",
        "Acceptance Criteria": "Intra- and inter-assay CV% over the range of approximately 5 to 45 µg/mL should not be greater than 6.1% and 6.0%, respectively.",
        "Reported Device Performance": "Max statistics for one kit lot show intra-assay CV% not greater than 6.1% and inter-assay CV% not greater than 6.0% over the range of approximately 5 to 45 µg/mL."
      },
      {
        "Criterion": "Linearity (Average Recovery)",
        "Acceptance Criteria": "Not explicitly stated as a numerical threshold, but implied to be acceptable for patient samples. The reported value is 96.0%.",
        "Reported Device Performance": "Average recovery for patient samples tested in the IMMULITE 2000/IMMULITE 2500 Vancomycin assay was 96.0%."
      },
      {
        "Criterion": "Spiked Recovery (Average % Recovery)",
        "Acceptance Criteria": "Not explicitly stated as a numerical threshold, but implied to be acceptable. The reported value is 101%.",
        "Reported Device Performance": "Average % recovery for spiked patient samples was 101%."
      },
      {
        "Criterion": "Interfering Substances (Bilirubin)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Bilirubin up to 20 mg/dL."
      },
      {
        "Criterion": "Interfering Substances (Hemoglobin)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Hemoglobin up to 600 mg/dL."
      },
      {
        "Criterion": "Interfering Substances (Triglycerides)",
        "Acceptance Criteria": "No significant interference (up to a stated concentration) on results within the precision of the assay.",
        "Reported Device Performance": "No significant interference from Triglycerides up to 3000 mg/dL."
      },
      {
        "Criterion": "Cross-Reactivity",
        "Acceptance Criteria": "No detectable cross-reactivity to various potential cross-reactants when vancomycin-spiked human serum sample is tested.",
        "Reported Device Performance": "No detectable cross-reactivity to a long list of substances (e.g., Acetaminophen, Amikacin, etc.) at high concentrations (typically 500 µg/mL), or Teicoplanin/CDP-1 at relevant concentrations."
      },
      {
        "Criterion": "Interference (HAMA/RF)",
        "Acceptance Criteria": "No detectable interference from HAMA or Rheumatoid Factor (RF) in tested samples.",
        "Reported Device Performance": "No detectable interference from HAMA (up to 1880 ng/mL) and RF (up to 2330 IU/mL)."
      },
      {
        "Criterion": "Sample Type Correlation (SST Serum vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For SST vs Serum: slope 1.00 (95% CI: 0.96 to 1.05), intercept -0.07 (95% CI: -1.43 to 1.28), r = 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y= 1.00 X - 0.07; slope = 1.00 (95% CI: 0.96 to 1.05); intercept = -0.07 (95% CI: -1.43 to 1.28); r = 0.99. Deming Regression: Y= 1.01 X - 0.28; slope = 1.01 (95% CI: 0.97 to 1.06); intercept = - 0.28 (95% CI: - 1.64 to 1.09)."
      },
      {
        "Criterion": "Sample Type Correlation (Lithium Heparin vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For Lithium Heparin vs Serum: slope 1.02 (95% CI: 0.97 to 1.06), intercept 0.03 (95% CI: -1.25 to 1.30), r = 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y=1.02 X + 0.03; slope = 1.02 (95% CI: 0.97 to 1.06); intercept = 0.03 (95% CI: -1.25 to 1.30); r = 0.99. Deming Regression: Y= 1.02 X - 0.15; slope = 1.02 (95% CI: 0.98 to 1.06); intercept = - 0.15 (95% CI: -1.43 to 1.14)."
      },
      {
        "Criterion": "Sample Type Correlation (EDTA vs Serum)",
        "Acceptance Criteria": "High correlation and equivalence between sample types. For EDTA vs Serum: slope 1.00 (95% CI: 0.96 to 1.04), intercept 0.001 (95% CI: -1.19 to 1.19), r= 0.99.",
        "Reported Device Performance": "Linear Least Squares: Y= 1.00 X + 0.001; slope = 1.00 (95% CI: 0.96 to 1.04); intercept = 0.001 (95% CI: -1.19 to 1.19); r= 0.99. Deming Regression: Y=1.01 X - 0.15; slope =1.01 (95% CI: 0.97 to 1.05); intercept = - 0.15 (95% CI: - 1.35 to 1.05)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2000 vs AxSYM Vancomycin II)",
        "Acceptance Criteria": "High correlation (r=0.97) between the platforms and the predicate device, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.971. Slope = 1.022 (95% CI: 0.983 to 1.061), Intercept = 0.727 (95% CI: 0.060 to 1.394)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2500 vs AxSYM Vancomycin II)",
        "Acceptance Criteria": "High correlation (r=0.97) between the platforms and the predicate device, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.966. Slope = 1.028 (95% CI: 0.985 to 1.071), Intercept = 0.495 (95% CI: -0.236 to 1.226)."
      },
      {
        "Criterion": "Method Comparison (IMMULITE 2500 vs IMMULITE 2000)",
        "Acceptance Criteria": "High correlation (r=0.970) between methods, indicating equivalence of assays.",
        "Reported Device Performance": "Linear Least Squares: r = 0.970. Slope = 0.981 (95% CI: 0.943 to 1.019), Intercept = 0.170 (95% CI: -0.526 to 0.866)."
      },
      {
        "Criterion": "Assay Kit Stability",
        "Acceptance Criteria": "Support a claim of 360 days shelf life when stored at 2-8°C, based on real-time and accelerated stress studies.",
        "Reported Device Performance": "Results of real-time and accelerated stress studies support the claim of 360 days shelf life for the assay kits when stored at 2-8°C."
      }
    ],
    "2_sample_size_and_data_provenance_test_set": {
      "Limit of Blank": {
        "Sample Size": "60 replicates of a zero analyte heparin plasma and serum sample, and the assay zero calibrator. Assayed across 3 IMMULITE 2000 kit lots (with 3 instruments per lot) and 1 IMMULITE 2500 kit lot (with 3 instruments per lot).",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Limit of Detection": {
        "Sample Size": "Five different samples with low concentrations of vancomycin (>0.4 ug/mL to 1.6 ug/mL). Assayed using 3 IMMULITE 2000 kit lots (2 instruments per lot) and 1 IMMULITE 2500 kit lot (2 instruments per lot). Eight runs of 2 replicates per sample over 8 separate days.",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Precision": {
        "Sample Size": "Two aliquots of each test sample in two runs per day over 20 different days, for a total of 80 replicates per test sample per lot. Three different kit lots on IMMULITE 2000 platform and one lot on IMMULITE 2500, with two instruments used per lot. Precision pools targeted 5, 10, 20, 30, and 45 µg/mL.",
        "Data Provenance": "Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied to be laboratory-generated samples for method validation."
      },
      "Linearity": {
        "Sample Size": "10 patient samples (neat, 4 in 8, 2 in 8 and 1 in 8 dilutions) across the therapeutic range (9 to 46 ug/mL). Each assayed in triplicate.",
        "Data Provenance": "Patient samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Spiked Recovery": {
        "Sample Size": "6 patient sample pools spiked with various concentrations of 3 different spiking solutions.",
        "Data Provenance": "Patient samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Interfering Substances/Cross-Reactivity/HAMA/RF": {
        "Sample Size": "Varies by substance. Typically, neat normal human serum and human serum spiked with 25 ug/mL vancomycin, spiked with the potential interfering substance. Assayed in 2 replicates. For HAMA/RF, 6 normal human samples for HAMA, 5 RF-positive human samples and 1 normal for RF.",
        "Data Provenance": "Human serum samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Alternate Sample Types (Correlation Study)": {
        "Sample Size": "SST vs Serum: N=33. Lithium Heparin vs Serum: N=32. EDTA vs Serum: N=31. Matched sets of human serum, SST, lithium heparin and EDTA samples spiked with various concentrations of vancomycin. Each run in duplicate.",
        "Data Provenance": "Human samples. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      },
      "Clinical Sample Population (Method Comparison)": {
        "Sample Size": "IMMULITE 2000 vs AxSYM II: N=162 endogenous serum patient samples. IMMULITE 2500 vs AxSYM II: N=162 endogenous serum patient samples. IMMULITE 2500 vs IMMULITE 2000: N=164 endogenous serum patient samples.",
        "Data Provenance": "Endogenous serum from patients being treated with vancomycin. Not explicitly stated (e.g., country of origin, retrospective/prospective)."
      }
    },
    "3_number_and_qualifications_of_experts_ground_truth": "N/A. This document describes the validation of an in vitro diagnostic assay (a laboratory test) for quantitative measurement of vancomycin. The 'ground truth' for this type of device is typically established through analytical methods and comparisons to a predicate device, rather than expert consensus on image interpretation or clinical diagnosis. The predicate device (AxSYM® Vancomycin II) serves as the reference for method comparison.",
    "4_adjudication_method_test_set": "N/A. Adjudication methods like 2+1 or 3+1 are typically used in studies involving subjective expert review (e.g., radiology diagnosis) to establish ground truth from multiple readers. This document describes analytical performance studies of a quantitative assay, where objective measurements are compared against reference methods or established analytical criteria. No human adjudication is mentioned or implied.",
    "5_mrmc_comparative_effectiveness_study": "No. This document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study involving human readers. The studies focus on the analytical performance of the device and its comparison to a predicate device, not on human-in-the-loop performance or the effect size of AI assistance for human readers.",
    "6_standalone_performance_study": "Yes. The entire document describes standalone performance studies of the IMMULITE 2000/2500 Vancomycin assays. The reported metrics (e.g., Limit of Blank, Limit of Detection, Precision, Linearity, Spiked Recovery, Interference, Cross-Reactivity, Sample Type Correlation, Method Comparison) represent the algorithm's (assay's) performance without human intervention in the measurement process, beyond initiating the automated assay and interpreting the quantitative result.",
    "7_type_of_ground_truth_used": "The ground truth for the analytical and method comparison studies relies on several approaches:\n\n*   **CLSI Guidelines:** For LoB and LoD, the 'ground truth' calculation methodology is defined by CLSI guidelines (EP17-A). Precision is guided by CLSI EP5-A2.\n*   **Analytical Standards/Spiking:** For linearity, spiked recovery, interfering substances, and cross-reactivity, ground truth is established by preparing samples with known, precise concentrations of vancomycin or potential interferents.\n*   **Predicate Device:** For method comparison and sample type correlation, the predicate device (Abbott AxSYM Vancomycin II) or the serum sample type (for correlation studies) serves as the reference or 'ground truth' method against which the new device's measurements are compared. This demonstrates substantial equivalence.",
    "8_sample_size_training_set": "N/A. For these in vitro diagnostic assays, the concept of a 'training set' in the machine learning sense is not directly applicable. The assay 'learns' and establishes its Master Curve at the site of manufacture using calibrators, which are not provided to customers. The document states that calibrators are used at the site of manufacture to establish the Master Curve. The specific sample size for this manufacturing calibration process is not provided in the document.",
    "9_how_ground_truth_for_training_set_was_established": "N/A. Similar to the training set concept, the 'ground truth' for the manufacturing calibration is established internally by DPC based on their proprietary calibration process using reference materials (Vancomycin adjustors and calibrators). The document states: \"In all IMMULITE platform instruments, calibrators are used at the site of manufacture to establish the Master Curve, which is encoded in the kit barcode label.\" The calibrators themselves are likely traceable to recognized reference standards for vancomycin concentration, establishing their 'ground truth'."
  }
}

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