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New ABC Test for Influenza A, Influenza B, and COVID-19 to Be Launched in First Week of October

By LabMedica International staff writers
Posted on 25 Sep 2020
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A new ABC Test (Influenza A/Influenza B/COVID-19) is anticipated to be ready for launch to US CLIA laboratory customers the first week of October 2020.

The ABC multiplex test is being developed by Co-Diagnostics, Inc. (Salt Lake City, UT, USA) which has already launched the Logix Smart Coronavirus 2019 (COVID-19) Test Kit. The in vitro diagnostic test that uses the company’s patented CoPrimer technology for the qualitative detection of the RNA from SARS-CoV-2 coronavirus (COVID-19). The Logix Smart Coronavirus 2019 (COVID-19) Test Kit 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).

Co-Diagnostics now expects its Logix Smart ABC Test (Influenza A/Influenza B/COVID-19) to be ready for launch to US CLIA laboratory customers the first week of October 2020. The test will initially be made available to CLIA labs that will be using it in their own laboratory developed tests, or LDTs, while the company proceeds with the FDA Emergency Use Authorization submission and CE marking registration.

"Co-Diagnostics is committed to participating in the fight against COVID-19 through the development and manufacture of vital diagnostic testing solutions, with none perhaps as important as this upcoming ABC multiplex test," remarked Dwight Egan, CEO of Co-Diagnostics. "Our patented CoPrimer™ technology platform is ideally suited for multiplex reactions by substantially reducing 'primer-dimers,' a phenomenon in PCR molecular tests that results in false positive results. At a time when the need for accurate detection of COVID-19 as well as the differentiation between strains of the flu has never been greater, we are pleased to be able to contribute to the safety and well-being of communities across the country and around the world."

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