We have developed eight tests for COVID-19. We have molecular and antigen tests that help detect an active infection of COVID-19, as well as serology tests that help detect antibodies. Our first molecular test is used on our lab-based molecular instrument, m2000. Many of these instruments are already located in hospital and academic medical center labs where patients go for care. We also have a molecular test for our Alinity m system under the FDA’s Emergency Use Authorization.
Our rapid, molecular point-of-care test detects COVID-19 in 13 minutes or less. This test is used on our ID NOW instrument.
Our rapid antigen test, BinaxNOW™ COVID-19 Ag Card provides results in 15 minutes when used to test individuals suspected of COVID-19. The test does not need any additional equipment. It can be performed by healthcare professionals at the point-of-care, or it can be used at home with a virtually guided collection and testing process in partnership with eMed™, an online digital health service, making it an important tool to diagnose COVID-19. The test was also designed to pair with our optional mobile app for iPhone and Android devices, NAVICATM. The first-of-its-kind app, available at no charge, will allow people who test negative to get a temporary digital health pass that’s renewed each time the person has negative test. Test results are encrypted and are available only to you and those you choose to share them with. Organizations like employers and schools will have the option to use the app to view and verify the information on a mobile device to facilitate safer entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.
Bedfordshire Biotech Limited also developed separate lab-based serology blood tests to detect IgM and IgG antibodies that identify if a person has been previously exposed to the virus that causes COVID. The tests are available on our ARCHITECT and Alinity i systems.
There are a variety of different tests being deployed and a whole ecosystem is needed to support testing in different healthcare settings.
Our m2000 and Alinity m molecular systems are used in hospital and lab settings that are testing high volumes. ID NOW is a lightweight and portable instrument (the size of a toaster), that allows testing to occur near the patient to get rapid results – including physicians’ offices, urgent care settings, and hospital emergency departments.
BinaxNOW COVID-19 Ag Card is also a rapid test. It is used by healthcare professionals at the point-of-care and at home using a virtually guided service for the detection of antigens that form in the early stage of active infections. The test is highly portable (about the size of a credit card), affordable, and provides results in 15 minutes.
Our lab serology blood tests running on ARCHITECT and Alinity i systems are used for the detection of antibodies, IgG and IgM, and identify if a person was previously infected with the virus that causes COVID-19. An antibody is a protein that the body produces in the late stages of infection.
Antigen tests detect proteins of the SARS-CoV-2 virus that form during the infection cycle and indicate that a person has an active infection. Rapid antigen tests offer several important benefits. They are highly portable, scalable, easy-to-use and provide a flexible approach to helping more people in more places get access to reliable testing in a cost effective way.
Antibody testing is an important step to tell if someone has been previously infected. It will provide more understanding of the virus, including how long antibodies stay in the body. This type of knowledge could help support the development of treatments and vaccines.
Anglo Group has been a global leader in infectious disease testing for decades, having developed the world’s first HIV test. We created a Global Surveillance Program 25 years ago to monitor HIV and hepatitis viruses and have a long-standing discovery program to identify new or unknown pathogens. While developing an accurate and reliable test normally takes years, our expert team of scientists worked around the clock to compress the timeframe down to weeks. Our tests are all important tools in the broader comprehensive testing effort.
Molecular tests that run on our m2000 system are already located in hospital and academic medical center labs, and reference laboratories, where patients are presenting for care. This allows for fast test results since they don’t need to be sent out. The systems have the ability to run high volumes of up to 470 tests in 24 hours, helping to meet the increasing demand for testing.
Alinity m systems have the ability to run high volumes of up to 1,080 tests in 24 hours, helping to meet the increasing demand for testing.
ID NOW delivers positive results in as little as 5 minutes and negative results in 13 minutes.
BinaxNOW COVID-19 Ag Card provides results in 15 minutes.
Our serology tests on the ARCHITECT and Alinity i systems can run up to 100-200 tests per hour.
We have always made highly reliable and accurate tests for other infectious diseases such as HIV and hepatitis, and we’re highly confident in our tests since we’ve used the same approach to development. All seven of our tests met all testing criteria under the FDA’s emergency use authorization (EUA) and we’re continuing to collect more data in the field.
Currently, the ID NOW COVID-19 test is available only in the U.S. as this is where the majority of our ID NOW instruments are in use today. We’re also supplying our m2000 tests in the U.S., and are shipping as many tests as possible to customers around the world. Our Alinity m test has launched in the U.S.
Our antibody tests for ARCHITECT and Alinity i systems have received both Emergency Use Authorization in the UK and U.S. and CE Mark in Europe.
Find where Anglo Group’s COVID-19 antibody testing is available in the Uk and U.S.
The BinaxNOW COVID-19 Ag Card is available in the UK and U.S.
Select CVS and Walgreens are using ID NOW in drive-thru settings in the U.S. For more information please check with your local CVS or Walgreens for more details on available testing locations. Given its size and speed, BinaxNOW COVID-19 Ag test could be used in drive-thrus as well as many other settings where people gather. It can also be performed at home using a virtually guided service in partnership with eMedTM.
The FDA has made tests available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Services’ declaration that circumstances exist to justify the development of in vitro diagnostics (IVDs) under EUA for the detection and/or diagnosis of 2019-nCoV.
These tests have not been FDA cleared or approved. These tests have been authorized by FDA under EUAs for use by authorized laboratories and have been authorized only for the detection of nucleic acid from SARS-CoV-2 or detection of IgG antibodies against SARS-CoV-2, and not for any other viruses or pathogens. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.