GS COVID-19RT-PCR diagnostic test : GenoSensor secures FDA EUA status
COVID-19 diagnostic test : GenoSensor has been granted emergency use authorization status from the US Food and Drug Administration (FDA) for its GS COVID-19 real-time reverse transcription-polymerase chain reaction (RT-PCR) diagnostic kit.
According to the genomic technology company, the kit has been developed to generate accurate and reproducible quality results to help in clinical decision-making over suspected Covid-19 infection patients.
The GS COVID-19RT-PCR is a molecular test that is said to help in identifying the SARS-CoV-2 virus that causes COVID-19 infection. The new coronavirus diagnostic test is said to enable the qualitative detection of nucleic acids from the SARS-CoV-2 virus in nasopharyngeal and oropharyngeal swab samples from patients who meet the CDC SARS-CoV-2 clinical criteria.
GenoSensor is said to provide the test with full-process positive, negative, and internal controls.
The GS COVID-19RT-PCR test has been designed to help in identifying three genes from the SARS-CoV-2 virus from clinical nasopharyngeal swab specimens.
GenoSensor secures FDA EUA status for GS COVID-19RT-PCR diagnostic test. Image courtesy of Visuals3D from Pixabay.
GenoSensor’s kit also consists of an internal positive control gene (GUSB), which acts as an extraction, reverse transcription, and PCR amplification control for each sample to minimize false negative results.
GenoSensor said that the Applied Biosystems 7500 Fast Dx real-time PCR instrument will be used to perform the GS COVID-19 RT-PCR test. The kit is available for the 96 well plate for 22 clinical samples and 384 well plate with 94 clinical samples, and will generate test results within 90 minutes.
James Xia – GenoSensor founder and president said: “Beginning in the early days of the COVID-19 outbreak in Wuhan, China, GenoSensor has been working with our international and U.S. colleagues to develop a highly sensitive and highly specific diagnostic that will provide healthcare teams and public health professionals with the diagnostic data they need to help people today and in the future.
“The GS COVID-19 RT-PCR KIT has achieved this goal and is now available. We are grateful to the FDA for their assistance and for this Emergency Use Authorization.”