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Here is how LumiraDx is making COVID-19 testing easier

Here is how LumiraDx is making COVID-19 testing easier
Ruchi Gupta
Oct 20, 2021, 13:32 PM
  • LumiraDx receives Emergency Use Authorization for its COVID-19 Antigen test
  • The antigen test is a microfluid test conducted on the company's POC platform
  • LumiraDx wants to make POC diagnostics accessible to all

LumiraDx (NASDAQ: LMDX) has received emergency user approval for the SARS-CoV-2 Antigen test in India from the Central Drugs Standard Organisation. The diagnostic Antigen test is designed to detect antigen nucleocapsid protein from nasal swab, and results are available within 12 minutes of the sample application.

LumiraDx SARS-CoV-2 antigen test comparable to PCR test

The company's SARS-CoV-2 antigen test shows 97.6% positive agreement and 96.6% negative agreement relative to the PCR test in clinical trials for patients within 12 days after symptoms start appearing. This makes it one of the most sensitive and quickest antigen point-of-care tests available. Following the EUA award from the US FDA in August 2020 and a CE Mark in September 2020, the test is now available in Europe and the US.

The SARS-CoV-2 Antigen test is a microfluidic test performed on the LumiraDx point-of-care Platform, which integrates lab analyzer techniques to give lab-comparable diagnostic tests on single point-of-care equipment. A tiny, portable instrument, a simple, standardized process, a microfluidic test strip, and seamless, secure digital communication to the cloud and hospital IT systems are all part of the Platform.

LumiraDx POC test accessible to all

LumiraDx Chief Commercial Officer David Walton said:

The company’s General Manager India, Yogesh Singh, said: