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 in 2021 to help with the COVID-19 crisis. Please note that this testing device will require FDA regulatory clearance and is meant to be used in consultation with a medical professional.
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 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.
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 in 2021 to help with the COVID-19 crisis. Please note that this testing device will require FDA regulatory clearance and is meant to be used in consultation with a medical professional.