Sample-to-answer and the steps of diagnostic workflow

Sample-to-answer systems bring the power of laboratory workflows into a compact, automated, and easy-to-use microfluidic device. These platforms take a raw sample, such as blood, saliva, swab material, or urine and process it all the way to a definitive analytical readout, without requiring traditional laboratory steps.

They are typically designed for situations where speed, simplicity, portability, robustness, and low cost matter most.

What is a sample-to-answer system?

A sample-to-answer system typically integrates one or more steps of a diagnostic workflow, including:

• Sample preparation: lysis, filtration, separation, concentration, extraction, dilution, or mixing operations with associated flow control elements.
• Reagent handling: reagent integration, with controlled release when needed. Surfaces can be modified to enable unique (bio)chemistries.
• Biochemical processing: isothermal amplification (LAMP), PCR, immunochemical reactions, enzymatic detection, or other targeted assays.
• Detection: optical, electrochemical, chemiluminescent, or other sensing modalities, depending on application needs. If required, the sensors can also be integrated on chip.
• Reporting / output: a clear visual or digital result that can be interpreted in seconds to minutes.

These systems eliminate the need for laboratory infrastructure and technical training, ensuring reliable results at the point of need.

Sample-to-answer platforms vs. personalized medicine diagnostic technologies

Sample-to-answer platforms differ from personalized-medicine diagnostic technologies. Where sample-to-answer platforms are optimized for fast detection of a small number of targets, personalized-medicine diagnostic technologies require broad and complex molecular analyses (typically comprehensive multi-omics or sequencing-based workflows).

Why sample-to-answer?

Sample-to-answer devices are optimized for detecting a limited number of biomarkers with ease of use, quickly, and affordably. This makes them ideal for point-of-care testing, decentralized diagnostics, field testing, infectious disease detection, and consumer health and wellness.

The main advantages of sample-to-answer devices are:

• Speed: results in minutes, not hours or days.
• Ease of use: minimal user steps; ideal for non-experts.
• Contamination control: closed-cartridge architecture minimizes user handling.
• Cost-effective: streamlined manufacturing and low reagent usage keep per-test cost low.
• Scalable manufacturing: microfluidic consumables can be produced at high volume using glass, polymer, or hybrid materials suited to regulatory compliance and point-of-care performance.

Micronit’s sample-to-answer platform: MYKEE

A fully developed example of Micronit’s sample-to-answer capabilities is the MYKEE platform. This is a rapid molecular diagnostic platform designed for point-of-need testing. MYKEE integrates:

• A low-cost disposable cartridge with dried LAMP reagents.
• A reusable, battery-powered reader with six independent reaction wells.
• Optical multispectral detection and precise thermal control.
• Cloud-connected data processing and a simple app-based user experience.

The system delivers lab-quality results in under 20 minutes from a single sample, enabling fast and reliable testing outside traditional laboratory settings. As an assay-agnostic OEM platform, it can be rapidly adapted to your needs.

Our capabilities in sample-to-answer development

Micronit supports the entire development cycle of sample-to-answer consumables and components.

Microfluidic chip engineering

• Custom channel structures and fluid routing
• Integrated valves, membranes, and reaction chambers
• Thermal zones for amplification or enzymatic reactions

Reagent integration

• Spotting, drying, and encapsulation of sensitive biological reagents
• On-chip storage solutions with long-term stability

Sample preparation functionalities

• Cell separation
• Nucleic acid extraction
• Mixing and controlled reagent release
• Lysis methods

Detection integration

• Optical paths, windows, and coatings
• Embedded electrodes for electrochemical readout
• Interfaces to reader hardware or handheld devices

Manufacturing excellence

• ISO-certified processes and production
• Over 25 years of experience covering all aspects from design to prototyping to high-volume scaling
• Rigorous quality monitoring throughout all development and manufacturing stages