The Nuclein™ Hand-Held PCR Test is designed to be a disposable, all-in-one, self-test for infectious disease diagnosis. It uses standard, real-time PCR, requires no technical expertise, and delivers battery-powered, sample-to-answer results in under one hour, without the need to mail in a sample. We are working tirelessly to make this available by fall 2020 to help with the COVID-19 crisis. Click here to learn more.
Please note that this testing device will require FDA regulatory clearance and is meant to be used in consultation with a medical professional. Please scroll to the “How It Works” section of this page for a technical overview.
The Nuclein Hand-Held PCR Test is designed to offer a simple PCR to test for infectious disease, providing accurate answers in under one hour. On-the-spot, self-test results can be available anywhere, at the push of a button, with the same standard real-time PCR technology used by the U.S. Centers for Disease Control and Prevention (CDC), other government agencies, and commercial labs.
Our testing device represents a technological leap in point-of-care infectious disease testing and could enable robust expansion in the types of interactions medical professionals can have with their patients via telemedicine.
Our testing device has been designed to accept a swab or saliva sample directly from the patient. From there, the diagnostic process can be activated by pushing a button, after which point the device automatically prepares the sample for analysis. Test results are then automatically displayed, in under one hour, as negative or positive on the LCD screen to the user.
The device is battery-powered, requires no external power source and is composed of a combination of plastic and aluminum.
Polymerase chain reaction (PCR) is a widely used technology that was first developed in 1983. The inventor was subsequently awarded the Nobel Prize, and PCR has long been a common and indispensable part of molecular biology. PCR is generally accepted as the gold standard in nucleic acid detection and is used for a broad variety of applications, including biomedical research, genetic testing and criminal forensics.
Our device is designed to run a real-time PCR reaction inside an all-in-one self-test, sample-to-answer, infectious disease testing solution.
Diagrams of the Nuclein™ Hand-Held PCR Test
How the Nuclein™ Hand-Held PCR Test Works
1. A user provides a sample directly into the receptacle of the Nuclein™ PCR Self-Test.
2. On activation, a plunger moves forward within the outer tube and in one motion, a vacuum in the reaction chamber draws the sample in, mixes it in the correct ratio with a shelf-stable liquid, delivers it into the reaction chamber in the correct volume, and seals it.
3. Inside the reaction chamber are a lyophilized lysis pellet, the magnetic displacer piston, and a lyophilized PCR pellet.
4. The lysis pellet is heated to break down the sample and then the piston mixes it with the PCR pellet, which stops the lysis and starts the PCR reaction.
5. The two sides of the reaction chamber (hot and cold) are maintained at the correct temperatures for PCR thermocycling. When the magnetic piston, which is driven by a coil and controlled by a small microprocessor, moves in one direction, it forces the liquid to move around it in the opposite direction, where it rapidly heats or cools to the correct temperature.
6. The detection element is able to observe the fluid contents of the reaction chamber throughout the thermocycling process. It uses simplified optics to take fluorescence readings by shining an LED into the chamber and monitoring the reaction through photodiodes.
7. These same steps and processes occur in expensive, benchtop PCR machines, but the Nuclein™ PCR Self-Test simplifies them for use in a rapid, hand-held, disposable, all-in-one self- test for infectious disease diagnosis without the need for a mail-in sample.
- Dimensions similar to the size of a soda can.
- ~6” long, 2” wide, and 3” tall
- Comparable to the weight of a soda can.
- ~12oz (less than 1 pound)
- Runs on batteries. No external power source is required.
How does this apply to COVID-19?
The ability to provide on-the-spot (also known as “point of care”) results in under an hour would make the Nuclein Hand-Held PCR Test an extremely useful tool in the current COVID-19 crisis. Supplementing the current testing paradigm, the limitations of which are discussed on The Challenge page, our PCR testing devices could be widely distributed wherever they are needed. Results in under one hour would allow faster, smarter decisions and lead to better outcomes.
Please note that our Nuclein Hand-Held PCR Test is moving towards manufacturing and not available at this time. We are working tirelessly to make this available by fall 2020 to help with the COVID-19 crisis. Click here to learn more. Please note that this testing device will require FDA regulatory clearance and is meant to be used in consultation with a medical professional.