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Product Overview

In Vitro Diagnostic Device for Methotrexate Measurement

Product Description

  • The product is a lateral flow in vitro diagnostic
  • It utilizes a double antibody system in order to achieve a high degree of sensitivity to measuring methotrexate only
  • It is able to work in conjunction with off-the-shelf readers to display the result
Figure 2 — Methotrexate Point of Care Device: cross-section of lateral flow test strip

Technical Specifications

Indication Point-of-care diagnostic test intended to detect the levels of Methotrexate (MTX) in whole blood
Sensitivity 0.04 μmol/L
Specificity No cross-reactivity to common blood species, in particular MTX metabolites (e.g. DAMPA) and leucovorin
CV % ≤ 20% CV
Detection Range 0.04–1000 µM in whole blood for detection of MTX
Sample Requirements 40 µl of venous blood (At Launch); capillary blood (Product Life Cycle)
Site of Testing Bedside
Time to Result ≤ 10 minutes
Sample Prep & Workflow Blood collection via lateral flow device → buffer addition

Intended Use: Resonance MTX Device is a point-of-care diagnostic test intended to detect the levels of Methotrexate (MTX) in whole blood.