Nucleic Acid Amplification Test Detects COVID-19 Without Using Instrument or Electricity

COVID-19 cases, hospitalizations and deaths have receded in most parts of the world, but public health officials continue to monitor for possible surges of the BA.2 variant, which is currently being seen in the US, Europe, and China. Many countries, especially those with lower incomes and fragile health systems, remain vulnerable to COVID-19 outbreaks. At-home tests offering PCR-like accuracy are oftentimes unaffordable for many low-income households when faced with having to purchase multiple test kits for use over multiple days. Researchers will soon begin clinical testing of a COVID-19 testing platform that could significantly address the global need for accessible, rapid, Nucleic Acid Amplification Tests (NAAT) that can be used by an unskilled user anywhere in the world without the need for an instrument or electricity.

Domus Diagnostics’ (Park City, UT, USA) reverse transcription loop-mediated isothermal amplification (RT-LAMP) test is intended to provide affordable, user-friendly, accurate and effective infectious disease detection to the general public. The Domus test uses a simple process in which the person collects a nasal swab specimen from each nostril, inserts a collection chamber into a card, and waits 30 minutes for the result. The Domus test, which can achieve testing accuracy on par with a PCR test, does not require instrumentation, electricity, or cold chain logistics. NAATs like Domus can detect COVID-19 earlier than widely available, at-home antigen tests, which are more effective when a person is contagious.

Domus’ goal is to produce a test that can be manufactured anywhere and sold at a price that is lower than what antigen tests. Initially, the test will be submitted for approval through the World Health Organization so that it can be provided to governments and public health organizations in developing countries at cost to address their need for accessible COVID-19 testing. Because the Domus platform can detect multiple targets from one sample, Domus will seek FDA authorization for a multiplex test for COVID-19 and seasonal flu after clinical trials have been completed.

“Domus’ vision is to provide a simple to use, highly accurate test that can be produced affordably at scale,” said Paul Chapman, president and CEO of Domus Diagnostics. “Our talented team of scientists and engineers have developed a truly innovative NAAT testing solution that can finally address those testing gaps that have existed for decades between the developing world and the West. This impact, we hope, will extend far beyond the current crisis and will enable better global preparedness for future pandemics.”

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