Genetron Receives FDA Emergency Use Authorization for SARS-CoV-2 RNA Test
By LabMedica International staff writers Posted on 09 Jun 2020 |
Image: Genetron SARS-CoV-2 RNA Test (Photo courtesy of Genetron Health)
Genetron Health (Beijing, China) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration for the company’s independently developed detection kit for the novel coronavirus.
The company’s new Genetron SARS-CoV-2 RNA Test kit has also received approval for export from the relevant authorities in China as well as obtained CE marking. Genetron SARS-CoV-2 RNA Test is an accurate, fast, contamination-free testing solution, which efficiently detects large-scale samples for the novel coronavirus. It detects two different and highly specific gene sequences of SARS-CoV-2: ORF1ab and N, which improves both its accuracy and specificity. It also includes an internal reference to prevent possible false negative results. Each test is capable of detecting SARS-CoV-2 RNA as low as 10 copies.
Using patented technology, the One-Step Seq Method, the process integrates reverse transcription of viral RNA and quantitative PCR reaction in a single step. The entire process takes less than 2.5 hours, including only 10 minutes of hands-on time. Additionally, the application of contamination resistant dUTP and UDG enzymes allows the system to degrade non-specific and nucleic acid-contaminated PCR products.
Related Links:
Genetron Health
The company’s new Genetron SARS-CoV-2 RNA Test kit has also received approval for export from the relevant authorities in China as well as obtained CE marking. Genetron SARS-CoV-2 RNA Test is an accurate, fast, contamination-free testing solution, which efficiently detects large-scale samples for the novel coronavirus. It detects two different and highly specific gene sequences of SARS-CoV-2: ORF1ab and N, which improves both its accuracy and specificity. It also includes an internal reference to prevent possible false negative results. Each test is capable of detecting SARS-CoV-2 RNA as low as 10 copies.
Using patented technology, the One-Step Seq Method, the process integrates reverse transcription of viral RNA and quantitative PCR reaction in a single step. The entire process takes less than 2.5 hours, including only 10 minutes of hands-on time. Additionally, the application of contamination resistant dUTP and UDG enzymes allows the system to degrade non-specific and nucleic acid-contaminated PCR products.
Related Links:
Genetron Health
Latest COVID-19 News
- New Immunosensor Paves Way to Rapid POC Testing for COVID-19 and Emerging Infectious Diseases
- Long COVID Etiologies Found in Acute Infection Blood Samples
- Novel Device Detects COVID-19 Antibodies in Five Minutes
- CRISPR-Powered COVID-19 Test Detects SARS-CoV-2 in 30 Minutes Using Gene Scissors
- Gut Microbiome Dysbiosis Linked to COVID-19
- Novel SARS CoV-2 Rapid Antigen Test Validated for Diagnostic Accuracy
- New COVID + Flu + R.S.V. Test to Help Prepare for `Tripledemic`
- AI Takes Guesswork Out Of Lateral Flow Testing
- Fastest Ever SARS-CoV-2 Antigen Test Designed for Non-Invasive COVID-19 Testing in Any Setting
- Rapid Antigen Tests Detect Omicron, Delta SARS-CoV-2 Variants
- Health Care Professionals Showed Increased Interest in POC Technologies During Pandemic, Finds Study
- Set Up Reserve Lab Capacity Now for Faster Response to Next Pandemic, Say Researchers
- Blood Test Performed During Initial Infection Predicts Long COVID Risk
- Low-Cost COVID-19 Testing Platform Combines Sensitivity of PCR and Speed of Antigen Tests
- Finger-Prick Blood Test Identifies Immunity to COVID-19
- Quick Test Kit Determines Immunity Against COVID-19 and Its Variants