Description
The ALS SARS-CoV-2 RT-LAMP kit is an in vitro diagnostic test that uses RT-LAMP technology for the qualitative detection of two specific regions of SARS-CoV-2 RNA in specimens collected from the upper respiratory tract (nasopharyngeal and oropharyngeal swabs). This kit should be used as a screening method for individuals with and without suspicion of COVID-19 disease, and as an alternative to the reference method for diagnosis of COVID-19 (real-time PCR). The test is particularly suitable for detecting SARS-CoV-2 in people who are in the infectious phase. The results of the ALS SARS-CoV-2 RT-LAMP kit represent the patient infection status at the time the test was performed. Negative results do not exclude SARS-CoV-2 infection and should not be used as the sole basis for patient treatment decisions. A presumptive positive result should be further verified by real-time PCR. The ALS SARS-CoV-2 RT-LAMP kit is suitable for use in point-of-care (e.g. physician’s offices, emergency care centres, schools, airports, nursing homes) and in hospital or clinical laboratory settings. The RT-LAMP reaction takes between 30-40 minutes, depending on the chosen analysis method (fluorescence or colorimetry). This test is indicated to be performed using native samples (without prior RNA extraction) or extracted RNA. Sample collection must be performed by qualified healthcare professionals, and the kit must be used by properly trained healthcare professionals and laboratory technicians with specific training in in vitro diagnostic procedures.