Respiratory testing has often required a trade-off between speed and accuracy. Beginning in 2020 during the onset of the COVID-19 pandemic, DiMonte Group played a major role in the design and development of the Nuclein DASH® Rapid PCR System, a compact point-of-care analyzer that performs lab-quality PCR and returns results in just 15 minutes.
The Challenge
Rapid antigen tests are convenient and fast, detecting viral proteins at the point of care in about 15 minutes—but their sensitivity drops sharply for patients with lower viral loads, often resulting in false negatives.
The gold standard for accuracy is Polymerase Chain Reaction (PCR), which detects the virus by amplifying its genetic material. However, conventional PCR machines are large, expensive, and laboratory-bound, meaning patient samples must be sent out and results can take days, delaying treatment and increasing risk of transmission.
Nuclein set out to change that. Their goal: deliver the accuracy of RT-PCR in a self-contained, portable instrument that could be used anywhere—doctor’s offices, clinics, or even school nurse’s stations.
The Solution
With the Nuclein DASH® Rapid PCR System, the entire PCR process is performed automatically inside a single-use cartridge.
A healthcare worker or patient collects a nasal swab, inserts it into the cartridge, and loads it into the analyzer. From there, the system:
- Lyses the virus and purifies RNA using preloaded reagents and magnetic particles
- Converts RNA to DNA enzymatically, then amplifies it
- Detects fluorescence changes in real time to determine the presence of viral DNA
- The result (positive or negative) is ready in 15 minutes
DiMonte Group’s Role
DiMonte Group partnered closely with Nuclein to bring the DASH® system from concept to fully functioning prototype.
Our contributions included:
- Electronics design – all circuit boards, including control and detection systems
- Embedded firmware – for motor control, thermal cycling, and fluorescence measurement
- Software development – Linux-based code handling test analysis and overall instrument control
- Industrial design – enclosure architecture and physical user interface
- Mechanical engineering – detailed system design, including the front panel and integrated assemblies
- Prototyping and testing – assembly of functional instruments and internal test fixtures
- Supply planning – identification and sourcing of long-lead-time components
Physical User Interface
DiMonte Group also designed the physical user interface (PUI), in the form of an LED ring surrounding the power button.
The display mimics the ticks of a clock, with light segments gradually illuminating as the 15-minute test progresses. When inactive, the LEDs remain hidden behind the front decal for a clean, minimalist appearance. Color and pattern variations communicate system states (progress, standby, or error) providing intuitive, glanceable feedback.
Test Fixture
DiMonte Group designed the PCBs in context of the machine’s compact size, ensuring board shapes and connector locations all fit within the final housing. After the PCBs and electromechanical systems were defined, we developed and assembled a dedicated test fixture used to 100% test all PCBs and electromechanical subsystems prior to assembly into the product, minimizing manufacturing downtime from failures that would otherwise require disassembly and rework.
Outcome
The Nuclein DASH® Rapid PCR System brings laboratory-grade molecular testing to the point of care, delivering accurate results in 15 minutes, all in a device compact enough to fit multiple units along a clinic countertop.
This project demonstrates DiMonte Group’s ability to integrate industrial design, electronics, firmware, and mechanical engineering into a compact, manufacturable medical device that’s both intuitive and scientifically sophisticated.
Learn More about the Nuclein DASH® Rapid PCR System
For more information visit nuclein.com.
