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ONLINE TDM Methotrexate is an in vitro test for the quantitative determination of methotrexate in human serum and plasma on cobas c systems. The determination of methotrexate is used for monitoring levels of methotrexate to ensure appropriate therapy.

The ONLINE TDM Methotrexate assay is an in vitro test for the quantitative determination of methotrexate in human serum and plasma on cobas c systems. The determination of methotrexate is used for monitoring levels of methotrexate to ensure appropriate therapy.

The ONLINE TDM MTX assay is a two-reagent system used for the detection of methotrexate in serum and plasma. In this technology drug hapten attached to the enzyme glucose 6 phosphate dehydrogenase (G6PDH) serves as the binding partner to anti-methotrexate antibody. A competitive reaction to a limited amount of specific anti-methotrexate antibody takes place between the enzyme bound hapten and free methotrexate in the sample. Enzyme activity is reduced with bound antibody. Only active enzymes reduce NAD+ to NADH. The rate of NADH formation during the reaction correlates to the methotrexate concentration and is measured photometrically.

The ONLINE TDM MTX assay is a homogeneous enzyme-immunoassay.

Reagents - working solutions

R1: Anti-methotrexate antibody (rabbit monoclonal), 3 µg/mL; NAD, G6P, bovine serum albumin in water, pH 6.3; preservative

R3: Methotrexate hapten conjugated to G6PDH, 0.3 µg/mL; bovine serum albumin in buffer, pH 7.8; preservative

The provided document describes the analytical performance evaluation of the "ONLINE TDM Methotrexate" assay. This is an in vitro diagnostic device used for the quantitative determination of methotrexate in human serum and plasma. The study aims to demonstrate that the device meets predefined acceptance criteria.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria & Reported Device Performance:

The document doesn't explicitly present a single table of "acceptance criteria" alongside "reported device performance" in a comparative format for all tests. Instead, it states for each section: "All acceptance criteria were met," and then provides the results. We can infer the acceptance criteria from the context and the reported successful outcomes.

Here is a reconstructed table based on the provided text, indicating the acceptance criteria (inferred from the "All acceptance criteria were met" statements and industry standards implicitly followed) and the reported performance.

• Control 1 (0.0863 µmol/L): 4.4% CV
• Control 2 (0.485 µmol/L): 0.9% CV
• Control 3 (0.849 µmol/L): 0.7% CV
• Human Serum 1 (0.0872 µmol/L): 4.0% CV
• Human Serum 2 (0.526 µmol/L): 0.8% CV
• Human Serum 3 (0.889 µmol/L): 0.7% CV
• Human Serum 4 (4.85 µmol/L): 1.0% CV
• Human Serum 5 (44.2 µmol/L): 4.0% CV
• Human Serum 6 (449 µmol/L): 3.7% CV
• Human Serum 7 (1334 µmol/L): 3.1% CV

Intermediate Precision:

• Control 1 (0.0737 µmol/L): 10.9% CV
• Control 2 (0.487 µmol/L): 1.2% CV
• Control 3 (0.841 µmol/L): 0.8% CV
• Human Serum 1 (0.0752 µmol/L): 11.2% CV
• Human Serum 2 (0.526 µmol/L): 1.3% CV
• Human Serum 3 (0.889 µmol/L): 1.1% CV
• Human Serum 4 (4.91 µmol/L): 2.0% CV
• Human Serum 5 (44.2 µmol/L): 5.3% CV
• Human Serum 6 (449 µmol/L): 6.3% CV
• Human Serum 7 (1316 µmol/L): 5.1% CV
  All stated to have met acceptance criteria. |
  | Analytical Sensitivity | LoB, LoD, LoQ within predefined thresholds to ensure accurate measurement at low concentrations. | LoB: ≤ 0.0250 µmol/L (claim in labeling)
  LoD:

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