The Logix Smart™ Coronavirus Disease 2019 (COVID-19) Test kit is an in vitro diagnostic test that uses Co-Diagnostics patented CoPrimer™ technology for the qualitative detection of the RNA from 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), and upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs) from patients who meet the clinical criteria (e.g. signs and symptoms) for coronavirus disease 2019 (COVID-19) as established by WHO (WHO, 2020) and the US CDC (CDC, 2020) (e.g. fever, cough, shortness of breath, travel history to China).
- 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
SARS-CoV-2 is the virus that causes COVID-19, a contagious, zoonotic disease that causes respiratory infection varying from common cold symptoms to severe pneumonia and occasionally death.
The Logix Smart Coronavirus Disease 2019 (COVID-19) test is a real-time RT-PCR test using a proprietary technology called CoPrimers™ (Satterfield, 2014)(Poritz & Ririe, 2014) intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in lower respiratory tract fluids (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), and upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs) from individuals with signs and symptoms of infection who are suspected of having COVID-19. The test is available to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories.
Negative results do not preclude SARS-CoV-2 infection 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 Coronavirus Disease 2019 (COVID-19) 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. The Logix Smart Coronavirus Disease 2019 (COVID-19) test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
References for the above citations:
Poritz, M., & Ririe, K. (2014, Mar). Getting things backwards to prevent primer dimers. Journal of Molecular Diagnosis, 159-62. doi:10.1016/j.jmoldx.2014.01.001
Satterfield, B. (2014, Mar). Cooperative primers: 2.5 million-fold improvement in the reduction of nonspecific amplification. Journal of Molecular Diagnosis, 163-73. doi:10.1016/j.jmoldx.2013.10.004
- Logix Smart COVID-19 Test Fact Sheet for Healthcare Providers
- Logix Smart COVID-19 Test Fact Sheet for Patients
Instructions for Use:
In February 2020, the Logix Smart COVID-19 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.
On April 3 2020 the Logix Smart COVID-19 Test kit obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2.
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, fatigue, dry cough, and shortness of breath. Cases of severe infection can result in pneumonia, acute respiratory distress syndrome (ARDS), and kidney failure leading to death in some cases. Based on early evidence, many of those who died had other conditions such as hypertension, diabetes, or cardiovascular disease that impaired their immune system.
Person-to person transmission, especially close contact, has been confirmed in asymptomatic and symptomatic phases of the disease. The degree of transmission on each phase has not been established yet. The incubation period has shown to be from 1 to 12.5 days, however, because SARS had a 14 days incubation period, the CDC and WHO recommends considering a 14 days incubation period where self-isolation and quarantine is recommended. There have been reported outliers of 24 days incubation period.