The Logix Smart™ Coronavirus Disease 2019 (COVID-19) Test kit is an in vitro diagnostic test developed and manufactured by Co-Diagnostics, Inc. that uses patented CoPrimer™ technology for the qualitative detection of the RNA from SARS-CoV-2 coronavirus (COVID-19).
The test operates using a real-time RT-PCR test intended for the in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in lower respiratory samples (e.g. bronchoalveolar lavage, sputum, tracheal aspirate), and upper respiratory samples (e.g. nasopharyngeal and oropharyngeal swabs) from individuals suspected of having COVID-19 by their healthcare provider.
Results are for the identification of SARS-CoV-2 RNA during the acute phase of infection. The Logix Smart Coronavirus Disease 2019 (COVID-19) 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. The test kit has been tested with the QIAamp® Viral RNA Mini Extraction Kit (Qiagen) on the CoDx Box thermocycler (Bio Molecular Systems).
The Logix Smart COVID-19 Test Kit:
- Contains a simple and streamlined workflow
- Includes internal control to verify sample quality
- Includes a positive control to verify master mix quality
- Produces results that are easy to interpret
- Is for use with lower and upper respiratory tract specimens
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
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 U.S. Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2.