The purpose of a Covid-19 antibody test is to determine whether or not a patient has had the disease, and possibly, whether or not they are now immune to re-infection. As such, Covid-19 antibody tests can be used to determine a country’s total immunity to the disease, which will allow social restrictions to ease and businesses to re-open.
The test uses a blood sample to identify antibodies and determine whether or not an individual has developed an immune reaction to the coronavirus. Antibodies are proteins secreted into the blood that bind to invading pathogens such as the novel coronavirus and alert the immune system to attack and destroy the virus.
The UK recently signed a contract with leading biotech companies Roche and Abbott for the supply of over 10,000,000 Covid-19 antibody tests. This number of tests would determine the immunity status for approximately 15% of the UK’s population. Although more testing will be necessary for a comprehensive understanding of the nation’s immunity to Covid-19, this is certainly a step in the right direction for the UK’s five key pillar national testing strategy, which was announced by the Secretary of State on 2 April. Pillar three outlines mass antibody testing to help determine whether individuals have immunity to Covid-19.
The Roche Elecsys Anti-SARS-CoV-2 Covid-19 antibody test received the US Food and Drug Administration’s (FDA) emergency use authorisation (EUA) on 3 May and is currently being used at more than 20 commercial and hospital lab sites across the US, including a partnership with one of the largest commercial diagnostic labs in the US, LabCorp. With plans to make the Covid-19 antibody test available in more than 200 sites over the next few weeks, wide adoption in the US is expected. Roche plans to provide tens of millions of tests in May for countries accepting the CE mark, as well as in the US and has plans to further ramp up manufacturing capacity, starting in June.
Abbott has shipped more than 7.2 million ARCHITECT Covid-19 antibody tests across the US. Abbott’s Alinity i Covid-19 antibody test was granted FDA EUA on 11 May and is the company’s second Covid-19 antibody test. While the ARCHITECT has been granted CE marking, Abbott is in the process of receiving CE marking for its Alinity i Covid-19 antibody test so that it can also be shipped to countries accepting the CE mark. Abbott plans to ship nearly 30 million antibody tests globally in May across its ARCHITECT and Alinity i platforms and will have capacity for 60 million tests in June.
According to a study released by the New York University (NYU) on May 12, Abbott’s ID NOW Covid-19 rapid polymerase chain reaction (PCR) test missed 33.3%–48.4% of positive samples detected by the next-fastest PCR test on the market Cepheid’s Xpert Xpress SARS-CoV-2 test. On 21 May, Abbott Laboratories released interim data from a clinical study that has 256 enrolled patients so far and includes five urgent care centres in New Jersey, Tennessee, Louisiana, Texas and South Carolina in the US. The interim analysis demonstrated that the ID NOW Covid-19 device had a sensitivity performance of 94.7% and a specificity performance of 98.6%.
Two other clinical studies sponsored by Abbott Laboratories demonstrated performance sensitivities of 83.3%–91.3% and specificities of 96.5%–100%. To date, Abbott has shipped more than 1.7 million ID NOW tests across the US. Despite a dip in Abbott’s stock following the NYU study, GlobalData expects that the controversy surrounding Abbott’s ID NOW Covid-19 test will not significantly impact Abbott’s bottom line, especially now as the company has been awarded a contract by the UK Government, which signals a vote of confidence.