SpectronRx has received the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for the HymonSARS-CoV-2 test kit, which detects virus causing Covid-19.
The therapeutic and diagnostic solutions provider said that the new test kit has a testing capacity of 94 samples, and takes only 1.5-hour for testing, from preparation to finish.
SpectronRx has partnered with HymonBio, a biotechnology company focused on molecular testing and in-vitro diagnostics, to produce 10 million tests per month for laboratories around the world.
SpectronRx CEO John Zehner said: “We are excited to contribute to the global battle against coronavirus by providing an efficient, real-time diagnostic PCR test to detect SARS-CoV-2.
“The shortage of tests nationwide has hindered proper diagnostic assessment of health in our communities, we are bringing testing to our communities, and hoping our contribution elevates the standard of diagnosis and provides a clear path of epidemiologic assessment during our ongoing fight against coronavirus.”
HymonSARS-CoV-2 test kit is designed to run on Applied Biosystems 7500 PCR systems
The HymonTMSARS-CoV-2 test kit is a real-time RT-PCR test developed for qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens and bronchoalveolar lavage specimens from people suspected of Covid-19, by healthcare providers.
Upper respiratory specimens are drawn from swabbing nasal, mid-turbinate, nasopharyngeal, and oropharyngeal surfaces.
The PCR test has been designed to run on Applied Biosystems 7500 PCR systems to obtain quick results in a broad range of healthcare settings including diagnostic labs and hospitals and can also be used in mobile or rural environments.
The clinical benefits offered by the test also include low laboratory footprint, limit of detection (LOD) of 1.2 copies of SARS-CoV-2 RNA/uL = 5 copies per reaction.
Recently, US-based life sciences and clinical diagnostics firm Agena Bioscience has launched the iPLEX Pro SARS-CoV-2 Panel for qualitative detection of the novel coronavirus.
The iPLEX Pro SARS-CoV-2 Panel runs on a single MassARRAY instrument, and enables clinical laboratories to process more than 6000 samples each day. – NS Medical Devices