Co-Dx™ Logix Smart® COVID-19 test kit
Boost speed and accuracy with real-time PCR testing
The Co-Dx Logix Smart COVID-19 test kit is an in vitro diagnostic test that uses our patented Co-Primers™ technology for the qualitative detection of the RNA from SARS-CoV-2 coronavirus that causes (COVID-19).
How it works
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 COVID-19.
Click here to read the Company’s regulatory bulletin on the ability of our suite of Co-Dx Logix Smart COVID-19 diagnostics to detect all known strains of SARS-CoV-2.
Test kit components
Ready-to-use Master Mix
Includes the complete mix for convenience and an Internal Positive Control - Human RNaseP gene marker
Positive Control
Synthetic control intended to amplify all targets included in the kit to ensure integrity of the entire run
Negative Control
Acts as a negative control to verify Master Mix is free from contamination
Additional information
The Co-Dx Logix Smart COVID-19 test kit 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.
Test kit performance & specifications
Logix Smart COVID-19 Performance Characteristics
Intended use
Qualitative real-time RT-PCR test for detection of the SARS-CoV-2 gene RdRp from individuals suspected by their healthcare provider of having COVID-19
Sample type
Lower respiratory tract fluids (branchoalveolar lavage – BAL, sputum, and tracheal aspirate) and upper respiratory tract fluids (nasopharyngeal and oropharyngeal swabs)
User
Qualified and trained clinical laboratory personnel instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures
COVID-19
Limit of detection (copies/μl)
Sensitivity*
Specificity*
Clinical Matrix Used for Analytical Verification
Analytical Specificity (in silico analysis)
No microorganism in the in silico analysis has revealed ≥ 80% homology between the cross-reactivity microorganisms, including the ones of relevance listed below.
IT DOES NOT cross-react with the following microorganisms: SARS-CoV, MERS-CoV, Human coronaviruses (HCoV-229E, HCoV-OC43, HCoV-NL63, HCoVHKU1), Adenovirus, influenza A H3N2, Novel influenza A H1N1, influenza B, influenza C, Metapneumovirus (hMPV), Parainfluenza 1, Parainfluenza 2, Parainfluenza 3, Parainfluenza 4, Respiratory syncytial virus (subtype A), Respiratory syncytial virus (subtype B), Parechovirus, Candida albicans, Corynebacterium diphtheriae, Legionella non-pneumophila, Bacillus anthracis, Moraxella catarrhalis, Neisseria elongata, Neisseria meningitides, Pseudomonas aeruginosa, Staphylococcus Aureus, Streptococcus salivarius, Leptospirosis, Chlamydia psittaci, Coxiella burnetti (Q-Fever), Staphylococcus epidermidis, Enterovirus, Rhinovirus, Haemophilus influenzae, Mycobacterium tuberculosis, Bordetella parapertussis, Mycoplasma pneumoniae, Chlamydia pneumoniae, and Legionella pneumophila.
Time to detection
Extraction System
Thermocycler compatibility
* Calculations are based on 90 negative and 90 positive replicates of contrived samples using synthetic SARS-CoV-2 RNA template, and the following reagent which was deposited by the U.S. Center for Disease Control and Prevention and obtained through BEI Resources, NAID, NIH: Genomic RNA from SARS-related Coronavirus 2, Isolate USA-WAI/2020, NR-52285
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Every test from Co-Dx is designed to be easy to use.
Regulatory clearance
In February 2020, the Co-Dx 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 Co-Dx 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: FDA Letter of Authorization
