Logix Smart™

ABC (Influenza A/B,

SARS-CoV-2) Test Kit

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.

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:

 https://www.cdc.gov/coronavirus/2019-ncov/symptoms-testing/symptoms.html

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.

Kit Specifications

Regulatory Clearance

In November 2020, the Logix Smart Influenza A/Influenza B/COVID-19 (“ABC”) 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).

SARS-CoV-2 (COVID-19)

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:

 https://www.cdc.gov/COVID19

Influenza (FluA/FluB)

Influenza (also known as the “flu”) is a contagious respiratory illness caused by influenza viruses. It can cause mild to severe illness, and at times can lead to death. Some symptoms of the flu and COVID-19 are similar, leading to difficulty differentiating between the two diseases based solely on symptoms.

According to the CDC, most people who get flu will recover in a few days to less than two weeks, but some people will develop complications (such as pneumonia) as a result of flu, some of which can be life-threatening and result in death.

While serious health problems related to the flu may happen at any age, including pneumonia, inflammation of the heart (myocarditis), brain (encephalitis) or muscle (myositis, rhabdomyolysis) tissues, sepsis as a result of an extreme inflammatory response in the body, and multi-organ failure (for example, respiratory and kidney failure), certain groups of people are at a higher risk of developing serious flu-related complications. This includes people 65 years of age and older, anyone with chronic medical conditions (e.g. asthma, diabetes, or heart disease), pregnant women, and children under 5 years old.

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Logix Smart™ ABC (Influenza A/B, SARS-CoV-2) Test kit

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