SpectronRx, Indianapolis, announced the FDA has expanded the emergency use authorization (EUA) for its Hymon SARS-CoV-2 Test Kit to include use with Applied Biosystems QuantStudio 5 Thermocyclers. Earlier authorization specified use with Applied Biosystems 7500 PCR systems only. This means more labs can now utilize the test kits without having to purchase additional diagnostic equipment. “We are excited that the FDA has expanded the emergency use authorization for our SARS-CoV-2 test kits to include use with Applied Biosystems QuantStudio 5 Thermocyclers,” says John Zehner, CEO of SpectronRx. “This will enable more labs to administer our efficient, real-time diagnostic PCR test for the detection of SARS-CoV-2. There is still a shortage of tests nationwide, and we are confident that our contribution will both elevate and expand the type of epidemiologic assessment available during our ongoing fight against coronavirus.” The Hymon SARS-CoV-2 Test Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens) and bronchoalveolar lavage specimens from individuals suspected of covid-19 by their healthcare provider. Key features of the Hymon SARS-CoV-2 Test Kits include:
- 5-hour testing time, from prep to finish
- 94 sample capacity (+ controls) per kit
- LOD (Limit of Detection) of 1.2 copies of SARS-CoV-2 RNA/uL = 5 copies per reaction
- Low laboratory footprint requirement
The Hymon SARS-CoV-2 PCR test can now be performed on both Applied Biosystems QuantStudio 5 Thermocyclers and 7500 PCR systems, providing rapid results in a wide range of healthcare settings such as diagnostic labs and hospitals in the United States, and can also be utilized in mobile or rural environments. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, to perform high complexity tests. SpectronRx and its partner HymonBio, Suzhou, China, are able to produce 10 million tests per month for laboratories around the world. For more information, visit SpectronRx.