Rheonix, a US-based developer of molecular diagnostic platforms, has commenced developing a fully-automated COVID-19 (coronavirus) test kit employing its Encompass MDx workstation.
Upon securing emergency use authorisation (EUA) approval from the Food and Drug Administration (FDA), the new test will enable detection of SARS-CoV-2, which is responsible for the coronavirus disease.
The company’s COVID-19 MDx assay will provide small and medium-sized labs access to fast, cost-effective, sample-to-answer testing for public health threat.
Rheonix scientific and clinical affairs senior vice president Richard Montagna said: “A fully automated sample-to-answer testing solution that can be reliably run by small and medium-sized labs will be critical in mobilising local and regional health networks to fight the COVID-19 public health emergency.
“We are grateful that the FDA is providing the flexibility necessary for innovative companies like Rheonix to act quickly to put testing in the hands of those most in need of rapid and dependable methods to control the spread of this virus.”
The Rheonix system provides test results in four hours
The company claims that its system delivers test results in four hours and needs no help from technician after the sample is loaded.
The Rheonix test can be easily executed due to its small workstation size, low per-sample test cost, and the capacity for the assay to be carried out by a single technician with no special training.
According to Rheonix, Encompass MDx workstation automatically introduces clinical specimens directly from their barcoded collection tubes into the wells of the microfluidic Rheonix CARD cartridges and processes all virus detection reactions on the cartridge within the closed workstation.
After the test is finished, all biological waste remains in the disposable cartridge and is wiped out.
The Rheonix test is designed for quick implementation at an extensive range of low- and medium-throughput laboratories such as regional hospital labs, physician offices, public health testing sites and clinics.
To test and validate the assay, Rheonix is working with a consortium of major New York state collaborators and inactivated samples of the coronavirus are being procured from ZeptoMetrix.
