FDA has granted emergency use authorization to the Hymon SARS-CoV-2 test kit from SpectronRx, South Bend, Ind.
The Hymon SARS-CoV-2 test kit is a real-time reverse-transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 virus. The test uses upper respiratory specimens (such as nasal, nasopharyngeal, mid-turbinate, or oropharyngeal swab specimens) or bronchoalveolar lavage specimens from individuals suspected by their healthcare provider of having covid-19.
Features of the kit include 1.5-hour testing time from preparation to finish; 94-sample capacity (plus controls); limit of detection of 1.2 copies of SARS-CoV-2 RNA per µL, which amounts to five copies per reaction; and a small laboratory footprint.
“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,” says John Zehner, chief executive officer of SpectronRx. “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.”
The test can be performed on the Applied Biosystems 7500 PCR system, available in a wide range of diagnostic and hospital laboratories. In the United States, use of the test is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.
SpectronRx and its partner, HymonBio, expect to produce 10 million tests per month for use in laboratories around the world. For more information, visit SpectronRx.