Application Notes

# OEM/ODM Custom Assay Development Workflow for POCT ## Abstract Custom assay development requires structured collaboration between POCT manufacturers and reagent suppliers. This application note outlines the OEM/ODM development workflow for lateral flow immunoassays, molecular diagnostics, and TRF platforms, from biomarker selection to regulatory submission. ## Introduction IVD companies increasingly outsource assay development to specialized … Read more

# Lyophilized Reagent Technology for Room-Temperature POCT ## Abstract Lyophilization (freeze-drying) enables room-temperature storage of temperature-sensitive POCT reagents, eliminating cold chain requirements. This application note details lyophilization protocols for lateral flow strips, PCR reagents, and CRISPR-based diagnostics for POCT manufacturers. ## Introduction Cold chain logistics account for 30-40% of POCT reagent costs in developing markets. … Read more

# Accelerated Stability Testing Protocol for POCT Reagents ## Abstract Stability testing is critical for POCT reagent registration and quality assurance. This application note describes an accelerated stability testing protocol for lateral flow strips, immunoassay reagents, and molecular diagnostic consumables, enabling POCT manufacturers to predict shelf life efficiently. ## Introduction Regulatory requirements (FDA, CE-IVD, NMPA) … Read more

# Whole Blood Sample Processing for Lateral Flow Immunoassays ## Abstract Direct whole blood analysis on lateral flow strips presents significant challenges due to matrix effects, hemolysis, and non-specific binding. This application note outlines sample processing strategies for POCT manufacturers developing lateral flow immunoassays that accept untreated whole blood specimens. ## Introduction Whole blood is … Read more

# Eu³⁺ Chelate-Based TRF Labeling for Ultra-Sensitive POCT ## Abstract Time-resolved fluorescence (TRF) immunoassays utilizing europium (Eu³⁺) chelate labels represent a significant advancement in point-of-care testing (POCT) sensitivity. This application note describes the labeling protocol and assay optimization strategies for POCT manufacturers developing ultra-sensitive lateral flow strips and TRF-based diagnostic platforms. ## Introduction Traditional lateral … Read more

Due Bio’s LF-detect strips provide objective, binary readouts for LAMP assays with 100-fold improved sensitivity over naked-eye detection.

Due Bio’s Lightning Reagents enable room-temperature extraction in under 5 minutes without centrifugation, columns, or purification.

Due Bio’s TRF Immunoassay Analyzer utilizes Europium Chelate technology to achieve 10–100× higher sensitivity than conventional methods.

Due Bio’s Microfluidic PCR Cartridge System integrates sample preparation, amplification, and detection in a closed, portable platform that delivers results in under 60 minutes.

Due Bio’s LF-detect 3-Plex strips enable simultaneous detection of three distinct targets in a single reaction—reducing costs and accelerating results.