1POT Professional MDx and 1copy COVID-19 MDx Kit

GENERAL INFORMATION LAMP (Loop-mediated Isothermal Amplification) is an isothermal technique for the amplification of nucleic acids. Unlike polymerase chain reaction (PCR) technology, where the reaction is carried out with a series of alternating temperature steps or cycles, isothermal amplification is performed at a constant temperature and does not require PCR equipment. The method is fast, highly sensitive, cost-effective and easy to perform even by unskilled persons. 1copy COVID-19 MDx Kit is a LAMP-based rapid test designed for point-of-care diagnosis of SARS-CoV-2. It targets the N and S genes of SARS-CoV-2 and provides a result with high accuracy, 8 times faster than traditional PCR. The test can be stored and transported at room temperature. The result is reported with a specialized platform including the 1POT testing device and a mobile smart device application. One-step testing, without prior RNA extraction, allows the speed of the test to be increased many times and to obtain a result within 22 minutes. FEATURES AND BENEFITS Detection of COVID-19 RNA with high accuracy and specificity based on isothermal amplification technology Direct detection from the sample, without the need for extraction Fast analysis – only 22 minutes to get the result Validated samples for analysis: nasopharyngeal secretion and nasal secretion Easy management and receipt of test results via a mobile application CE-IVD certified system Suitable for professional use as well as for independent testing MATERIALS AND REAGENTS Nasopharyngeal swab Sample buffer tube Test tube with 2 positions 1POT Device 1POT Professional application Instructions for use TEST PROCEDURE Video instructions: CE-IVD