Co-Diagnostics, Inc. products

The Logix Smart™ Coronavirus Disease 2019 (COVID-19) Test kit is an in vitro diagnostic test that uses our 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).

The Logix Smart™ ZDC (ZIKV-DENV-CHIKV) Test kit uses our patented CoPrimer™ technology to differentiate between the ribonucleic acid (RNA) of Zika, dengue (all 4 serotypes), and chikungunya viruses and to detect and amplify regions of the viruses’ genomes. The test operates using a single step real-time reverse transcriptase polymerase chain reaction (RT-PCR) process in serum samples, collected alongside with urine, from patients suspected of being infected with Zika, dengue, or chikungunya. The Logix Smart ZDC kit is designed and validated to identify Zika, dengue or chikungunya viruses even when more than one target is present, such as in co-infections. The presence of one target does not interfere with detection of any other targets. If a patient specimen is positive for Zika, a CSF specimen can also be collected to search for neurological infection.

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.

The Logix Smart™ SARS-CoV-2 (genes RdRp/E) Test kit is an in vitro diagnostic test that uses our patented CoPrimer™ technology for the qualitative detection of two genes (gene RdRp and gene E) from the RNA of 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), upper respiratory tract fluids (e.g. nasopharyngeal and oropharyngeal swabs), and saliva during the acute phase of detection.

The Logix Smart™ Mycobacteria Tuberculosis (MTB) Test is the first test built using our CoPrimer™ technology to receive regulatory clearance for use as an in vitro diagnostic. It is designed to detect the presence or absence of deoxyribonucleic acid (DNA) of mycobacteria tuberculosis complex members. Real-time polymerase chain reaction (PCR) amplifies the IS6110 and MPB64 regions of the pathogen genome. The amplified product is then detected by fluorescent dyes (FAM, CF560, and CF610).