Updated May 5
The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Roche Elecsys® Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2. Roche has already started shipping the new antibody test to leading laboratories globally and will ramp up production capacity to the high double-digit millions by mid-May to serve healthcare systems in countries accepting the CE mark¹ as well as the U.S.
What is an “antibody test” and a “serology test”? What type of sample is required?
An antibody test detects antibodies that an individual produces after exposure to a pathogen such as the novel coronavirus. A serology test is a diagnostic test involving blood serum—the part of a person’s blood that contains proteins other than those involved in blood clotting. Roche’s new test is both an antibody test and a serology test in that it uses blood serum to determine the presence of antibodies associated with exposure to the SARS-CoV-2 virus. From patients, blood samples drawn by health-care professionals are required, similar in size to samples drawn for common lab tests.
Why are such tests important in dealing with the COVID-19 epidemic?
Antibody tests such as Roche’s can assess if a person was exposed to the SARS-CoV-2 virus. The test may be used in epidemiological research to better understand the spread of the disease, and together with molecular tests, to aid in the diagnosis of suspected COVID-19 patients. If further studies confirm that antibodies confer immunity to SARS-CoV-2, and how long this immunity lasts, then this could help determine if individuals can go back into the workforce without risk of being infected and infecting others.
Are specific instruments needed to run the Roche antibody test? Are they the same instruments used with the cobas® SARS-CoV-2 Test? If not, why not?
Roche’s antibody test is performed on a cobas e analyzer—cobas e 411, cobas e 601/602, or cobas e 801. The cobas e analyzers required for the antibody test are not the same as the cobas 6800/8800 platforms used with Roche’s molecular test for SARS-CoV-2. The technology of serology testing is different.
Where are the tests, the cobas e analyzers, and the needed consumables made?
The Roche antibody test is being developed in Penzberg, Germany, and produced in Penzberg and Mannheim, Germany. The analyzers on which this test will run are produced in Japan. Other components, such as system consumables and reagents, originate throughout our global supply chain network.
How many tests will you have, and how will you decide where to distribute them?
We anticipate producing high double-digit millions of tests per month globally.
What is the installed base of cobas e analyzers in the U.S.?
More than 3,000 cobas e analyzers of the four models are installed in the U.S.
How many tests will be going into my lab/location/state?
We are committed to deliver the broadest geographic impact to areas most impacted by the virus. In alignment with the government, we will focus on ensuring laboratories in high population density areas have access and scale global production rapidly in an effort to expand broader access as quickly as possible.
Are you coordinating allocation of these tests with the Federal Government?
We remain in constant dialogue with the White House coronavirus task force and government agencies with regard to the allocation of tests and other issues related to the pandemic.
Will you keep producing your COVID-19 diagnostic test and support the Research Use Only (RUO) solution you announced in February?
Yes, we have been increasing production of the cobas® SARS-CoV-2 Test, which received EUA on March 12, 2020. We also continue to support laboratories carrying out SARS-CoV-2 testing on our LightCycler® and cobas z 480 Analyzers to run the TIB Molbiol LightMix® assays.
What is the price of the Roche antibody test and how does it compare with similar tests?
In pandemic situations like this, cost should not be a barrier to accessing diagnostics. We are committed to delivering as many tests as possible to people who need them.
Individual labs determine the price of the tests they offer to patients.
Do you have enough supply of reagents and consumable materials to manufacture the antibody test and allow laboratories to use it in large numbers?
We are confident in our ability to manufacture the antibody test in large and growing numbers in the weeks ahead. When planning the ramp up of our test, we have taken a holistic view on all the different consumables and general purpose reagents that are needed to run the test. We are in close contact with the suppliers of the system consumables and ramping up production to ensure the assumed increased demand coming from anti-SARS-CoV-2 testing can be fulfilled.
Will Roche’s test be an IgG, IgM or IgG/IgM assay?
The Roche Anti-SARS-CoV-2 assay detects high affinity antibodies, using the double antigen sandwich (DAGS) format. The Roche assay will detect IgM, IgA, or IgG antibodies if they are high affinity antibodies, which appear in the late or convalescent phase of infection. This approach offers excellent specificity, as evidenced by the 99.81% specificity across 5,272 samples, and greatly reduces the risk of false positives.
Why is Roche developing an antibody test for SARS-CoV-2?
The primary purpose of our test is to assess exposure status to SARS-CoV-2. We evaluated multiple antigens to choose the best assay format. Our high affinity antibody assay design targets only mature antibodies, and has less probability of detecting weakly cross-reacting antibodies than an indirect assay format. Since understanding exposure to the virus is most important at this phase of the pandemic, an assay design with high specificity and low cross-reactivity is key.
What specimen type is needed for the Anti-SARS-CoV-2 assay?
This test will run Serum, Li-heparin Plasma, K2 EDTA, and K3 EDTA.
How long does it take to get a result?
The assay will be an 18 minute test.
What is the specificity of the test?
Based on the measurement of a total of 5272 samples, the Elecsys® Anti-SARS-CoV-2 assay has 99.81% specificity and shows no cross-reactivity with the common cold coronaviruses. This means it can lower the chance of false positives.
What is the clinical sensitivity?
The assay exhibited 100% clinical sensitivity for samples collected >14 days after PCR confirmation. Please visit the product page for more detailed information.
How can customers order the Anti-SARS-CoV-2 assay?
At this time, access to the test will be limited. We are working to ensure access to labs with the broadest geographic reach to the highest population densities impacted the most by COVID-19. The situation is fluid, as we adapt our strategy in realtime to provide the greatest patient impact, we will provide updates on our COVID-19 Updates page.
On March 12, 2020, Roche received FDA Emergency Use Authorization for the cobas® SARS-CoV-2 Test to detect the virus that causes COVID-19, which the World Health Organization has classified as a pandemic. Hospitals and reference laboratories can run the test on Roche’s fully automated cobas® 6800 and cobas® 8800 Systems, which are widely available in the U.S. and around the world.
How does the test work?
The test detects the genetic signature (RNA) of the SARS-CoV-2 virus in swab samples that a healthcare provider collects from the back of the patient’s throat or nose.
Where is the test performed?
Healthcare providers can send patient samples to hospital and reference laboratories across the U.S. to run the test. As of April 28, 2020 there are currently 100 hospitals and laboratory sites serving all 50 states and Puerto Rico.
Where is the test made?
Roche designed the test in California and produces it in New Jersey. The cobas 6800/8800 Systems are manufactured in Switzerland.
How fast is the test?
After the lab starts the test, results are available in about 3.5 hours. The instruments can process up to 384 results (cobas 6800 System) and 1056 results (cobas 8800 System) in an 8-hour shift.
How many tests can you supply?
Roche began shipping tests to U.S. laboratories on March 13. We were initially able to supply 400,000 tests per week to the U.S. market and continue to improve our production capabilities to increase weekly supply for our customers. We are currently shipping approximately 8 million tests per month worldwide.
What is the price of the test?
Although our EUA test was the first new commercial test introduced during this unprecedented pandemic, its price remains consistent with all other standard viral tests for use on the cobas® 6800/8800 Systems platform.
Will there be enough tests to meet demand?
We are doing everything possible to produce as many tests as we can. Since this is a global health emergency, demand is outpacing supply.
Roche welcomes the subsequent Emergency Use Authorization (EUA) of more than 25 additional tests developed by our competitors, spanning various platforms and features, which together will help to meet demand.
How is Roche deciding what customers get the test?
We are working to ensure the greatest access for patients in the U.S. – and the rest of the world - by bringing together the nation’s public-health interests with the development and testing capacities of the private sector. In close consultation with the government we are supporting the national public health strategy by prioritizing access to:
The situation is fluid and we are adapting our strategy in real time. We monitor daily customer inventory levels and test usage. This information helps us update our allocation planning as necessary to ensure that we provide testing supplies where and when they are needed most
Where can patients get the test?
Roche does not supply tests directly to patients. If you think you have been exposed to COVID-19 and develop a fever and symptoms, such as cough or difficulty breathing, call your healthcare provider for medical advice. The test can only be ordered by a medical professional and is intended for patients who meet the clinical and epidemiological criteria for COVID-19 testing.
Do you foresee any disruption to the test supply as a result of closed borders?
Given the importance of these tests, we have been able to work with the authorities to ensure continuity of supply and we do not anticipate closed borders being an obstacle.
Will travel restrictions impact the ability to service hospitals / instruments running the SARS-CoV-2 test?
Our focus remains to keep customers up and running. We have a task force that meets daily to ensure rapid response to emerging crisis topics that may impact support. Our current strategies that are intended to keep our employees safe, optimize our service and keep our customers in operation include:
Is Roche going to launch other diagnostic solutions in support of this current pandemic?
Roche is deeply committed to supporting the global response to the COVID-19 outbreak. We will continue to bring all of our organizational expertise and resources to this battle. Given Roche’s broad suite of diagnostic solutions, we have numerous options between high-volume, centralized testing to rapid, decentralized testing. We’ll continue to evaluate the epidemiology of the disease and public health needs to help us determine how to best support this healthcare crisis. We remain open to all platform development options.
Roche does not supply tests directly to patients. These are lab based tests that can only be ordered by a medical professional and are intended for patients who meet the clinical and epidemiological criteria for COVID-19 testing.
Healthcare providers can send patient samples to hospital and reference laboratories across the U.S. who have the ability to run both Roche tests.
Roche COVID-19 (Coronavirus) Updates