Co-Dx™ Logix Smart® SARS-CoV-2 Direct Saliva (DS) test kit
Boost speed and accuracy with real-time PCR testing
The Co-Dx Logix Smart SARS-CoV-2 DS test kit is an in vitro diagnostic test that uses our patented Co-Primers™ technology for the qualitative detection of two genes (gene RdRp and gene E) from the RNA of SARS-CoV-2 (coronavirus that causes COVID-19), using a sample processing technique that eliminates the use of the nucleic acid extraction/purification process.
How it works
The test operates using a single step real-time reverse transcriptase polymerase chain reaction process to to detect SARS-CoV-2 in minimally processed saliva.
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
The Co-Dx Logix Smart SARS-CoV-2 DS test kit includes the following components.
Ready-to-use Master Mix
Includes the complete mix for convenience and an Internal Positive Control (IPC) - 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 SARS-CoV-2 DS test is a real-time PCR multiplex test intended for the in vitro qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) targeting the genes RdRp in the polygene Orf1ab region and gene E of the virus genome, in minimally processed saliva samples from individuals suspected of having COVID-19.
The Co-Dx Logix Smart SARS-CoV-2 test 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.
Test kit performance & specifications
Logix Smart SARS-CoV-2 DS Performance Characteristics
Application
Qualitative Multiplex real-time RT-PCR test for the detection of SARS-CoV-2 RNA targeting two genes (gene RdRp in the polygene Orf1ab region and gene E) using a sample processing technique that eliminates the use of the nucleic acid extraction/purification process.
Limit of Detection
Thermocycler
Sample of Treatment Method
LoD (>95% detection)
(Co-Diagnostics)
(Co-Diagnostics, Inc)
(BioMolecular Systems)
(Co-Diagnostics, Inc)
(Thermo Fisher Scientific)
(Co-Diagnostics, Inc)
(Bio-Rad)
(Co-Diagnostics, Inc)
(Thermo Fisher Scientific)
(Co-Diagnostics, Inc)
(Thermo Fisher Scientific)
Analytical Specificity (Wet test cross reactivity)
Does not cross-reactive with: Human coronavirus OC43, Human coronavirus HKU1, Human coronavirus NL63, MERS-coronavirus, Human (hMPV), Parainfluenza virus3, Enterovirus (e.g., EV68), Respiratory syncytial virus. Rhinovirus, Chlamydia pneumoniae, Haemophilus influenzae, Legionella pneumophila, Mycobacterium tuberculosis, Streptococcus pneumoniae, Streptococcus pyogenes, Bordetta pertussis, Mycoplasma pneumoniae, Pneumocystis jirovecii (PJP), respiratory tract microflora, Candida albicans, Pseudomonas aeruginosa, Staphylococcus epidermidis, Streptococcus salvarius
It may cross-react poorly with SARS-coronavirus (2003)
Sensitivity*
Specificity*
Sample type
Proteinase K Reagent Compatibility
MagMAX™ Viral/Pathogen Proteinase K (Thermo Fisher Scientific)
Time to detection
Thermal cycler compatibility
- Co-Dx box (Co-Diagnostics, Inc.)
- MIC cycler (BMS, Biomolecular Systems)
- QuantStudio 5 (Thermo Fisher Scientific)
- CFX96 (Bio-Rad)
- ABI 7500 Fast Dx (Thermo Fisher Scientific)
- FAM (green channel): SARS-CoV-2
- CF610 (ROX) (red channel): Internal Positive Control (IPC) Human RNaseP
Extraction kit compatibility
* Results obtained from clinical evaluation with 30 remnant positive saliva samples and 30 negative paired saliva and anterior nasal swabs
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Every test from Co-Dx is designed to be easy to use.
Regulatory clearance
In June 2021, the Co-Dx Logix Smart SARS-CoV-2 DS 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 U.S. Food and Drug Administration (FDA). This product is not available for sale within the United States.
