SARS-CoV-2 RNA STAR Complete of LumiraDx Approved by UK MHRA


The MHRA of the United Kingdom has now given the approval to the SARS-CoV-2 RNA STAR Complete developed by LumiraDx. The SARS-CoV-2 RNA STAR Complete has been developed with the non-isothermal nucleic acid amplification qSTAR technology, which has been the new and rapid corona virus molecular assay has been designed for detecting the nucleic acid from the corona virus in the swabs of the upper respiratory collected from the suspects of corona virus.

It has also been using a direct method of one step for the extraction and amplification of the nucleic acid on the validated instruments of the open RT-PCR. As the SARS-CoV-2 RNA STAR Complete has been validated by CTDA (Covid-19 Test Device Approval) has been providing the results within 20 minutes and it has also been contributing to the productivity and efficiency of the labs.

This new assay is also going to be authorized for the use by the individuals that are non-symptomatic and also the others without have any reason for suspecting the novel corona virus when either of the collected data under the supervision of the healthcare provider, and the test that has been showing a positive agreement of 95.4 percent as compared to another highly sensitive assay of RT-PCR in the clinical trials.

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David Walton, chief commercial officer of LumiraDx said, since the beginning of the corona virus pandemic, they have also been pleased for supporting the healthcare system of the United Kingdom.


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