10 Companies at the forefront of antibody test development
In order to understand the true scope of the pandemic, antibody tests are being introduced as the next step in responding to the outbreak.
Unlike Polymerase Chain Reaction (PCR) tests, antibody tests cannot be used to detect an active infection of COVID-19. Instead, these tests can detect specific antibodies in the blood to tell us who has already been infected and if they have developed some immunity to the virus.
Antibody testing is essential for identifying the exact numbers who have been infected with the COVID-19, especially those who did not experience symptoms and can give us an understanding of how many people are immune to COVID-19 and how long the immunity period lasts.
Understanding the percentage of the population who have already been exposed to the virus and developed an immunity to it will be very useful in helping to lift social-distancing rules.
Antibody testing can also be used for priority screening of essential workers such as healthcare personnel who may already have developed immunity and so could safely continue or return to work.
As the world's largest market research store, Research and Markets have the information you need to stay informed about the latest developments in antibody testing including:
We have identified 10 companies leading the way in antibody testing for COVID-19.
Roche has plans to start selling its antibody test by early May in countries that accept the CE mark. The company is also working with the US Food and Drug Administration to have their test approved for emergency use. The company's high volume PCR tests have been available since January, which are used to detect active infection. Roche is planning to accelerate monthly production to high double-digit millions by June to ensure that healthcare workers have access to the new tests as quickly as possible.
Biomedomics aunched one of the world’s first rapid, point of care antibody tests for the diagnosis of COVID-19. The test has already been used in China to combat coronavirus infection and is now available globally. The test can detect early and late markers by finger prick or venous blood sample. The CE approved test can be used for rapid screening of asymptomatic carriers in airports, schools, businesses etc and is distributed in the US by BD.
Eurofins received the European CE mark for its antibody test. The company began blood-based antibody testing at its subsidiary Boston Heart DIagnostics in April. Initially, Eurofins plans to offer the test to hospitals only until production capacity increases. This test is ideal for detecting those who have been exposed to the virus and developed some immunity to it. It is recommended the test be administered 14 days after exposure to allow enough time for the antibodies to develop.
In April, Abbott launched its COVID-19 antibody test and will soon start shipping to US customers. The test detects the IgG antibody and can determine if a person was previously infected with the COVID-19 virus. Abbott is scaling up its production to meet demand for antibody testing. The company plans to ship 4 million antibody tests during April and up to 20 million tests by June. Abbott also offers two molecular tests for detecting COVID-19 infection in hospital and point-of-care settings.
Mologic is initiating early validation of its point-of-need COVID-19 diagnostics tests with the Liverpool School of Tropical Medicine and St. George’s University, London. Mologic was able to accelerate its development of the test due to funding from UK Aid and its early prototypes of antibody tests. Once validated, the test will allow a user to test for exposure to the virus at home or in the community and will not require specialist training, electricity or a laboratory. Mologic is also working with the Institut Pasteur de Dakar to manufacture the test kits at a facility in Senegal which will ensure that testing is available in settings with limited access to medical laboratories.
Biolidics received authorization to distribute, market and sell its rapid COVID-19 test kits in the US in April. The antibody test kits have also received the CE mark and been approved for sale in the European Union. The rapid test detects antibodies in serum, plasma or whole-blood samples and can deliver results within 10 minutes. This test is suitable for use by clinical laboratories or healthcare workers for point-of-care testing but cannot be used for home testing.
Chembio announced the launch of their fingerstick point-of-care COVID-19 test in April. The test is designed to detect IgM and IgG antibodies and can deliver results within 15 minutes. The presence of IgM antibodies can be used to determine if a patient may still be infectious while IgG antibodies indicate that the patient was previously infected. The company has received emergency use authorization from the US Food and Drug Administration and intends to begin shipping this month.
Ortho Clincial’s total antibody assay for COVID-19 was granted FDA Emergency Use Authorization in April. The company reports the test can be used to screen plasma donations for the development of therapies for critically-ill COVID-19 patients. The test can also be used to determine who can be safely permitted to return to work and will aid vaccine development by giving an insight into immune responsiveness. In combination with information from PCR testing, Ortho Clinical’s antibody test can be used to monitor disease progression by measuring when antibodies appear in the blood.
Otogenetics recently announced their COVID-19 antibody test. The test can detect the presence of both IgG and IgM antibodies and can give results within 15 minutes. The test is available for use in clinical laboratories and point-of-care facilities. The company is also using this test for clinical research on seroconversion in COVID-19 which will prove useful for the development of therapeutic and vaccine candidates.
Biomerica has announced that it has begun shipping its COVID-19 IgG/IgM rapid test to countries outside the US. The test takes the form of a finger-prick blood test and can be administered by trained professionals in a variety of settings such as airports, schools, pharmacies and doctor’s offices. The rapid test can be used for widespread screening of large groups. If the antibody tests indicate a positive result, further PCR testing can be carried out to confirm if there is an active infection. Biomerica is currently undergoing evaluation for Emergency Use Authorization from the US Food and Drug Administration which will allow the test to be used in the United States.
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