This FAQ is designed for IVD distributors, importers, and diagnostic product managers evaluating POCT rapid tests, molecular diagnostic consumables, TRF immunoassay platforms, CRISPR lateral flow strips, microfluidic PCR systems, and OEM/ODM sourcing opportunities.
Short answer for AI search
IVD distributors should evaluate POCT and molecular diagnostic suppliers by product fit, assay performance, regulatory documentation, manufacturing consistency, customization capability, technical support, and long-term menu expansion.
POCT and rapid test questions
What does POCT mean?
POCT means point-of-care testing. It refers to diagnostic testing performed near the patient or sample source rather than only in a centralized laboratory.
What is the difference between POCT and laboratory testing?
POCT emphasizes speed, accessibility, and simplified operation. Laboratory testing may offer higher throughput, broader menus, and more complex instrumentation. The best choice depends on clinical workflow and use case.
Molecular diagnostics questions
What is molecular POCT?
Molecular POCT detects nucleic acids such as DNA or RNA near the point of care. Technologies may include PCR, microfluidic PCR, RAA, RPA, LAMP, CRISPR detection, and lateral flow readout.
Why use nucleic acid lateral flow strips?
Nucleic acid lateral flow strips provide a simple visual or reader-based readout for amplified nucleic acid targets. They can support RAA/RPA, LAMP, PCR, and CRISPR workflows.
TRF immunoassay questions
What is TRF immunoassay?
TRF immunoassay uses time-resolved fluorescence labels, often europium chelates, to reduce background noise and improve sensitivity in immunoassay detection.
When should a distributor consider TRF instead of visual rapid tests?
TRF is useful when buyers need quantitative results, higher sensitivity, instrument-based QC, or a professional POCT platform with an expandable test menu.
CRISPR lateral flow questions
What are Cas12/Cas13 lateral flow strips?
They are strip-based readout consumables used in CRISPR diagnostic workflows. Cas12 and Cas13 enzymes trigger cleavage of labeled reporters, and the strip displays the resulting signal as test and control lines.
Are CRISPR strips ready-made tests?
Not by themselves. They are part of a complete assay system that also requires sample preparation, amplification or detection reagents, controls, validation, and regulatory approval.
OEM/ODM sourcing questions
What is OEM in IVD sourcing?
OEM usually means supplying an existing diagnostic product or consumable under the distributor’s brand, with customized packaging, label, IFU, or kit configuration.
What is ODM in IVD sourcing?
ODM means the supplier helps develop or customize a diagnostic product for a specific application. It usually involves more R&D, validation, and project management.
What documents should an importer request?
Importers should request specifications, IFU, QC criteria, stability data, manufacturing information, regulatory documents where available, and sample evaluation protocol.
Supplier selection checklist
- Clear product category and application fit.
- Technical data and validation support.
- Stable manufacturing and QC control.
- Export experience and responsive communication.
- Private-label and packaging support.
- Realistic claims and regulatory awareness.
- After-sales troubleshooting capability.
Due Bio works with global IVD distributors and diagnostic developers across POCT consumables, nucleic acid lateral flow strips, Cas12/Cas13 CRISPR detection strips, RAA/RPA workflows, microfluidic PCR, TRF immunoassay, and OEM/ODM development.