ALS SARS-CoV-2 RT-LAMP

The ALS SARS-CoV-2 RT-LAMP kit is an in vitro diagnostic medical device (CE-IVD) which was developed in close partnership with the International Iberian Nanotechnology Laboratory (INL) and produced entirely in Portugal at ALS.

The kit uses RT-LAMP technology that allows a rapid nucleic acid amplification, for the detection of SARS-CoV-2 and stands out for being simpler and faster than the real-time PCR alternative methods. The kit was designed and validated to be used with native upper respiratory tract samples from individuals with or without suspicion of COVID-19, without the need of RNA extraction by conventional methods. Furthermore, this technology relieves the use of complex laboratory apparatus as it resorts to visual interpretation of the results by color change. Its performance is comparable to the RT-PCR reference method for COVID-19 diagnosis and suitable for use in point-of-care. Alternatively, it can be used in a laboratory environment where there is the possibility of carrying out nucleic acid extraction and monitoring the results by fluorescence.

The chosen target regions are highly conserved regions of the SARS-CoV-2 genome, corresponding to the Nsp3 and N genes. Results are obtained in about 45 minutes, allowing the detection of at least 10 copies/uL of SARS viral RNA -CoV-2. This time can be reduced to 25 minutes in the case of fluorescence detection in the laboratory.