COVID-19 Assay Kit

A real-time fluorescent RT-isothermal assay based on Atila’s proprietary isothermal amplification technology intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal swabs and saliva specimens from individuals with signs and symptoms of infection who are suspected of COVID-19.
Fast. Simple. Accurate.

CE marked

Details

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient’s infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

The iAMP COVID-19 SANO Assay is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time nucleic acid amplification and in vitro diagnostic procedures.

* The iAMP COVID-19 Sample Collection Device and iAMP COVID-19 Sample Collection Device NP are for Research Use Only; not for use in diagnostic procedures. Not yet available as CE marked product.