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Logix Smart - Model SARS-CoV-2 DS - Diagnostic Test Kit
The Logix Smart™ SARS-CoV-2 DS (Direct Saliva) Test kit is an in vitro diagnostic test that uses our patented CoPrimer™ technology for the qualitative detection of two genes (gene RdRp and gene E) from the RNA of SARS-CoV-2 coronavirus (COVID-19), using a sample processing technique that eliminates the use of the nucleic acid extraction/purification process.
The test operates using a single step real-time reverse transcriptase polymerase chain reaction (RT-PCR) process to detect SARS-CoV-2 in saliva from patients suspected of having COVID-19.
Click here to read the Company’s regulatory bulletin on the ability of our suite of Logix Smart COVID-19 diagnostics to detect all known strains of SARS-CoV-2.
Each Logix Smart SARS-CoV-2 DS Test kit consists of the following components:
- Ready-to-use Master Mix, complete with RNaseP internal positive control to verify sample quality
- Positive Control (PC), to verify the performance of the master mix
- Nuclease-Free Water as a negative control, to verify master mix is free from contamination
COVID-19 is a contagious respiratory illness caused by the SARS-CoV-2 virus, a relatively new virus in humans. COVID-19 can present with a mild to severe illness, although some people infected with COVID-19 may have no symptoms at all. Older adults and people of any age who have underlying medical conditions have a higher risk of severe illness from COVID-19. Serious outcomes of COVID-19 include hospitalization and death. The SARS-CoV-2 virus can be spread to others not just while one is sick, but even before a person shows signs or symptoms of being sick (e.g., fever, coughing, difficulty breathing, etc.). A full list of symptoms of COVID-19 can be found at the following link:
The Logix Smart SARS-CoV-2 DS test is a real-time RT-PCR multiplex test intended for the in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) targeting the genes RdRp in the polygene Orf1ab region and gene E of the virus genome, in minimally-processed saliva samples from individuals suspected of having COVID-19.The Logix Smart SARS-CoV-2 test is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.
Instructions for Use can be found under the Resources tab.
