In-Vitro Diagnostics
Microfluidic Diagnostic Cartridge
A microfluidic cartridge routes sample and reagents through molded micro-channels read by an optical instrument. The material set is driven by optical clarity, low autofluorescence, tight micro-replication, and low water uptake so channel geometry stays stable.
Sterilization: GammaE-BeamEthylene Oxide
Component material package
A recommended grade per component, drawn from the Nexeo catalog. Recommendations are engineering assessments; a cited property links the choice to data we hold for that grade.
| Component | Recommended grade | Why |
|---|---|---|
Fluidic chip body Optically clear micro-channel substrate | Zeonex 690R Cyclic Olefin Polymer (COP) | A cyclic olefin polymer offers very low water absorption and low autofluorescence, which keeps channel dimensions and optical reads stable. Cited: Water Absorption |
Optical window / lens Detection window for the reader | TOPAS 6013M-07 Cyclic Olefin Copolymer (COC) | A COC grade provides high transmittance and low birefringence for the optical detection path. Cited: Light Transmission |
Cover film seal frame Rigid frame for the channel-sealing lid | Eastman Tritan MX711 Copolyester (Copolyester) | A clear copolyester frame bonds well and resists the alcohols and buffers common in reagents. |
Producer datasheetNexeo Applications Engineering assessmentAwaiting datasheetNot published by producer
Key regulatory requirements
- ISO 10993 for any residual patient-contact path (often IVD-exempt, confirm intended use)
- Low-autofluorescence and low-extractables data for assay validation
- ISO 11137 if terminally sterilized
Engineering watch-outs
- Autofluorescence is assay-specific — request lot-level optical data before committing.
- COC/COP are stiff but notch-sensitive; design generous radii on micro-features.
- Solvent-bonding vs laser-welding the lid changes the grade short-list; decide the seal method first.
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