Healgen’s COVID-19 IgG/IgM Rapid Test Kit Granted FDA Emergency Use Authorization
By LabMedica International staff writers Posted on 03 Jun 2020 |
Image: The Healgen COVID-19 IgG/IgM rapid test cassette (Photo courtesy of Healgen Scientific, LLC)
Healgen Scientific, LLC’s (Houston, TX, USA) COVID-19 IgG/IgM Rapid Test Kit has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).
As a result of the FDA authorization, Confirm BioSciences (San Diego, CA, USA), the largest North American distributor for Healgen, a subsidiary of Zhejiang Orient Gene Biotech, maker of the COVID-19 test, will have an ample supply of test kits for medical professional use starting in early June. Confirm expect to have millions of tests available, enough to satisfy existing pre-orders and future orders. Zhejiang has also appointed Aytu BioScience, Inc. (Englewood, CO, USA) as the US distributor for the COVID-19 test and has delivered more than 1.4 million rapid tests to the company for distribution in the country.
An easy-to-use test kit that provides results in just 10 minutes, COVID-19 IgG/IgM Rapid Test kits are designed for use with whole blood, serum or plasma samples. With a high degree of accuracy, the kits detect IgM that may appear in blood within three-five days following incubation and IgG that appears as soon as 1-2 weeks. As part of the FDA review, a National Institutes of Health (NIH) study comparing rapid test kits found that the COVID-19 Rapid Test demonstrated excellent performance. The tests are authorized for prescription use only for use in high or moderately complex CLIA laboratories. The kits have a shelf life of 24 months from the date of manufacture and can be stored at room temperature or in a refrigerator.
"We have received positive feedback on the test from our customers and independent studies, so the FDA Emergency Use Authorization validates what we already knew from real-world clinical applications," said Albert Berger, Chief Executive Officer, Confirm BioSciences. "This pandemic is an enormous challenge for medical professionals and everyone else, and as a major distributor, we're proud to do our part to increase testing capacity so that healthcare professionals can help contain the spread of the virus."
As a result of the FDA authorization, Confirm BioSciences (San Diego, CA, USA), the largest North American distributor for Healgen, a subsidiary of Zhejiang Orient Gene Biotech, maker of the COVID-19 test, will have an ample supply of test kits for medical professional use starting in early June. Confirm expect to have millions of tests available, enough to satisfy existing pre-orders and future orders. Zhejiang has also appointed Aytu BioScience, Inc. (Englewood, CO, USA) as the US distributor for the COVID-19 test and has delivered more than 1.4 million rapid tests to the company for distribution in the country.
An easy-to-use test kit that provides results in just 10 minutes, COVID-19 IgG/IgM Rapid Test kits are designed for use with whole blood, serum or plasma samples. With a high degree of accuracy, the kits detect IgM that may appear in blood within three-five days following incubation and IgG that appears as soon as 1-2 weeks. As part of the FDA review, a National Institutes of Health (NIH) study comparing rapid test kits found that the COVID-19 Rapid Test demonstrated excellent performance. The tests are authorized for prescription use only for use in high or moderately complex CLIA laboratories. The kits have a shelf life of 24 months from the date of manufacture and can be stored at room temperature or in a refrigerator.
"We have received positive feedback on the test from our customers and independent studies, so the FDA Emergency Use Authorization validates what we already knew from real-world clinical applications," said Albert Berger, Chief Executive Officer, Confirm BioSciences. "This pandemic is an enormous challenge for medical professionals and everyone else, and as a major distributor, we're proud to do our part to increase testing capacity so that healthcare professionals can help contain the spread of the virus."
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