The company has developed the in-vitro diagnostic test kits using the rapid molecular isothermal nucleic acid amplification technology
Switzerland-based ender diagnostics has received the US Food and Drug Administration (FDA) notification, allowing to market two of its Covid-19 tests in the US.
Ender’s US subsidiary Ender Diagnostics North America, is set to deliver the rapid Covid-19 testing kits, dubbed ender LAB and ender MASS, to US laboratories willing to increase testing capabilities.
The company has developed its ender LAB and ender MASS in-vitro diagnostic test kits using the rapid molecular isothermal nucleic acid amplification technology.
Ender Diagnostics CMO Heidi Horsch said: “It enables the implementation of a sustainable testing strategy by reliably detecting contagious individuals carrying high viral loads.
“Because ender MASS only takes 30 minutes, it enables laboratories to significantly increase their testing throughput as well as addressing the supply chain shortages experienced during this pandemic.”
ender LAB and ender MASS work on standard RT-PCR devices
Intended for use only by laboratory professionals or trained operators, the diagnostic test kits work on standard real-time PCR devices.
Ender LAB is capable of providing the results within 30 minutes after the extraction of the viral RNA, which is considerably faster than normally used PCR tests.
The test kit is an appropriate solution for a clinical set-up, as it offers 97.7% sensitivity and 100% specificity to reliably identify all infected individuals, said the company.
Ender MASS designed to perform the test without the need of a conventional RNA extraction, which saves hours of lab time and reduces the use of consumables.
The test kit is said to be an optimal laboratory-based solution for mass-testing in a public health set-up, as it is capable of detecting SARS-CoV-2 virus within 30 minutes after sample preparation.
Ender Diagnostics is specialised in developing molecular diagnostic test kits for the rapid and consistent detection of SARS-CoV-2, which causes Covid-19.