Logix Smart - Model ABC (Influenza A/B, SARS-CoV-2) - Diagnostic Test Kit
From Diagnostic Solutions
The Logix Smart™ ABC (Influenza A/B, SARS-CoV-2) Test kit is an in vitro diagnostic test that uses our patented CoPrimer™ technology for the qualitative detection of the RNA from the Influenza A, Influenza B, and SARS-CoV-2 viruses. The multiplex test operates using a single step real-time reverse transcriptase polymerase chain reaction (RT-PCR) process in lower respiratory tract specimens (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), upper respiratory tract specimens (e.g. nasopharyngeal, nasal, and oropharyngeal swabs), and saliva from individuals suspected of Influenza A, Influenza B or coronavirus disease 2019 (COVID-19) and its related conditions.
Product Details
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 ABC Test kit consists of the following components:
- Ready-to-use Master Mix, complete with internal positive control (human RNaseP) to verify sample and extraction quality
- Positive Control (PC), to verify the performance of the master mix and stability of components
- Nuclease-Free Water as a negative control, to verify master mix is free from contamination
Product Description
The Logix Smart ABC (Influenza A/B, SARS-CoV-2) test kit is a real-time RT-PCR multi-analyte test using proprietary CoPrimer™ technology intended for the qualitative simultaneous detection and differentiation of nucleic acid from Influenza A, Influenza B, and SARS-CoV-2, targeting conserved regions of the viruses genomes 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 Influenza A, Influenza B, or coronavirus disease COVID-19 and its related conditions.
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:
Positive results are indicative of the presence of Influenza A, Influenza B, and/or SARS-CoV-2 genomic material; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Many laboratories are required to report all positive results to the appropriate public health authorities.Negative results do not preclude Influenza A, Influenza B, and/or SARS-CoV-2 infections and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
The Logix Smart ABC test is intended for use by qualified and 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.
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