SARS-CoV-2 (genes RdRp/e) Test Kit
The Logix Smart™ SARS-CoV-2 (genes RdRp/E) 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).
The test operates using a single step real-time reverse transcriptase polymerase chain reaction (RT-PCR) process in lower respiratory tract fluids (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs), and saliva during the acute phase of detection.
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 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 (genes RdRp/E) 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 lower respiratory tract samples (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), upper respiratory tract samples (e.g. nasopharyngeal and oropharyngeal swabs), and saliva from individuals suspected of 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.
In November 2020, the Logix Smart SARS-CoV-2 test kit received CE marking approval, the principle regulatory clearance allowing the test to be sold as an in vitro diagnostic (“IVD”) for the diagnosis of COVID-19 in European Union states and other markets that accept a CE-IVD mark as valid regulatory approval.
Is this test FDA-approved or cleared?
No. This test is not yet approved or cleared by the United States FDA. When there are no FDA-approved or cleared tests available, and other criteria are met, FDA can make tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). This product is not available for sale within the United States.
The disease was first reported in 31-Dec-2019 by the Chinese government to the World Health Organization (WHO) after a cluster of pneumonia of unknown cause was identified in the city of Wuhan, Hubei province, China. The virus was found genetically similar to SARS-CoV, responsible for the 2002-2003 outbreak of severe acute respiratory syndrome. Signs and symptoms include fever or chills, fatigue, cough, shortness of breath or difficult breathing. Based on early evidence, many of those who died had other conditions such as hypertension, diabetes, or cardiovascular disease that impaired their immune system.
COVID-19 is primarily spread from person-to person transmission, for this reason, the CDC recommends social distance of 6-feet apart from a person who has COVID-19. Other ways to limit the spread of the virus include frequent hand washing with soap and water for at least 20 seconds, or using alcohol-based hand sanitizer that contains at least 60% alcohol; wear a mask that covers the nose and mouth in public settings; clean and disinfect frequently touched surfaces, and stay home as much as possible and avoid close contact with others.
- For the most up to date information on COVID- 19 please visit the CDC Coronavirus Disease 2019 (COVID-19) webpage:
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Logix Smart™ SARS-CoV-2 (genes RdRp/E) Test kit