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MicrosensDx Nabs CE Mark for Rapid SARS-CoV-2 LAMP Test

NEW YORK – UK molecular diagnostics firm MicrosensDx said on Thursday that its RapiPro LAMP SARS-CoV-2 test has garnered CE marking. 

The loop-mediated isothermal amplification test returns results in less than 30 minutes and has shown 97 percent sensitivity and 96 percent specificity in validation studies, the company said in a statement. The sensitivity and specificity numbers are for both symptomatic and asymptomatic individuals and include people with low and high viral loads.

MicrosensDx said the test was trialed with an unnamed laboratory partner by offering symptomatic and asymptomatic screening programs at large industry sites, Department of Health and Social Care settings, and "Test-to-Release schemes." 

The technology has the potential to detect multiple pathogens, including norovirus, respiratory syncytial virus, or influenza, the company said.

The test can be configured for use in high-throughput laboratories and has been validated on multiple platforms, such as OptiGene's Genie II, Genie III, and Genie HT platforms for up to 96 samples. It can also be used at the point of care by a healthcare professional with minimal training, the company added. It can be run with any CE-marked nucleic acid extraction kit but was designed for use with MicrosensDx RapiPrep extraction technology.

"Rapid, accurate testing remains vital to the COVID-19 response, even as vaccine rollout gathers pace around the world," MicrosensDx CEO Mark Street-Docherty said in a statement. "LAMP tests offer greater speed than PCR tests and greater sensitivity than lateral flow antigen assays." He added that the company is scaling production of the test in the UK.