COVID-19 Testing FAQs

 

Updated December 1

Elecsys Anti-SARS-CoV-2 Test FAQs

Elecsys Anti-SARS-CoV-2 Test FAQs

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.

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.

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.

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.

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.

We anticipate producing high double-digit millions of tests per month globally.

More than 3,000 cobas e analyzers of the four models are installed in the U.S.

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.

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.

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.

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.

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.

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.

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.

This test will run Serum, Li-heparin Plasma, K2 EDTA, and K3 EDTA.

The assay will be an 18 minute 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.

The assay exhibited 100% clinical sensitivity for samples collected >14 days after PCR confirmation. Please visit the product page for more detailed information.

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.

 

 

SARS-CoV-2 FAQs

SARS-CoV-2 FAQs

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.

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.

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.

Roche designed the test in California and produces it in New Jersey. The cobas 6800/8800 Systems are manufactured in Switzerland.

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.

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.

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.

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.

Individual labs determine the price of the tests they offer to patients.

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.

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:

  1. Large commercial laboratories—with the necessary instruments in place—that can quickly collect, process and move samples to maximize testing capabilities and provide the widest geographic coverage.
  2. Hospitals and laboratories in geographic regions that are currently experiencing large-scale community spread of infection.

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

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.

 

 

GENERAL FAQS

GENERAL FAQS

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.

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:

  • Providing credentials and documentation to service personnel to ensure emergency travel capabilities to customer sites.
  • Remote, home-based set up for all personnel not required on customer sites, including the Customer Support Center.
  • Increased stock of spare parts located regionally, including supply at alternate warehouses.
  • Dedicated toll-free line for customers who are allocated SARS-CoV-2 testing for related parts ordering. This ensures a more streamlined experience for both customers running COVID-19 related testing and those who need support for routine testing.

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.

 

 

SARS-CoV-2 & Influenza A/B FAQs

SARS-CoV-2 & Influenza A/B FAQs

On September 3, 2020, Roche received U.S. Food and Drug Administration Emergency Use Authorization for the cobas® SARS-CoV-2 & Influenza A/B Test for use on the cobas® 6800/8800 Systems. This PCR test simultaneously identifies and differentiates SARS-CoV-2, Influenza A, and B and enables labs to provide reliable, consolidated, and accurate answers by leveraging the widely available, high-volume cobas® 6800/8800 Systems.

This test distinguishes between three different targets: SARS-CoV-2, Influenza A and Influenza B. SARS-CoV-2 is the virus that causes COVID-19. COVD-19 and influenza present with similar symptoms and may be difficult to identify just on symptoms alone. With this accurate and reliable test, healthcare workers can now have three differentiated results from one test and one sample.

Trained healthcare providers can take nasal or nasopharyngeal swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. A nasal swab sample can also be self-collected in a healthcare setting with instruction by a healthcare provider.

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.

Since the worldwide recognition of the novel coronavirus pandemic risk in January, our singular focus has been - and continues to be - to support the global response to the outbreak of COVID-19. Initially, current customers who are running the Roche SARS-CoV-2 test, which received EUA in March, will be receiving this test. 

The ultimate price a patient will pay is determined by many factors, including what the lab charges for the test and what insurance will cover. Roche believes cost should not be a barrier to accessing diagnostics, and we certainly price all tests responsibly.


This is a diagnostic test that is ordered by a healthcare professional and is not available for home use. Please contact your healthcare provider for more information.

Samples are taken by a healthcare worker using either a nasopharyngeal or nasal swab, including patient-collected nasal swab, under the instruction of a healthcare provider.

 

 

SARS-CoV-2 &amp; Influenza A/B Test <br> for&nbsp;<b>cobas</b><sup><sup>®</sup></sup> Liat<sup><sup>®</sup></sup> System FAQs

SARS-CoV-2 & Influenza A/B Test
for cobas® Liat® System FAQs

On September 14, 2020, the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Roche cobas SARS-CoV-2 & Influenza A/B multiplex test for use on the cobas Liat system. This is the first molecular point-of-care multiplex test that differentiates SARS-CoV-2, Influenza A and Influenza B. This test provides urgent, accurate answers to rule in or rule out both SARS-CoV-2 and Influenza A/B within 20 minutes, reducing the risk of a misdiagnosis in emergency care settings by differentiating these similarly presenting infections.

This test distinguishes between three different targets: SARS-CoV-2, Influenza A and Influenza B. SARS-CoV-2 is the virus that causes COVID-19. COVD-19 and influenza present with similar symptoms and may be difficult to identify just on symptoms alone. With this accurate and reliable test, healthcare workers at emergency care locations can identify in just 20 minutes whether a symptomatic patient has SARS-CoV-2 or an Influenza A or B infection.

This is a point-of-care (POC) test, meaning it can be performed at the point of care, such as in an emergency room or urgent care clinic. This test can be conducted by a wide variety of healthcare workers, without the need to send samples to a laboratory. Both lab-based and POC testing have an important place in healthcare, and in the case of the current COVID-19 pandemic, it is important to leverage both approaches to meet the demand for widespread testing.

This test runs on the cobas Liat System, which is an innovative molecular testing solution ideally suited for fast, urgent diagnostic answers needed in point of care settings. It consists of a small compact instrument, no bigger than a shoebox, and a uniquely designed closed assay tube to minimize the chance of cross-contamination

Since the beginning of the pandemic, demand for diagnostic instruments, assays and associated materials has been outpacing supply. While the cobas Liat System is widely used across the U.S., production of the new test itself is complex, and its availability will be limited. Initial stocks will be allocated to fill critical gaps in testing infrastructure--in particular to enable emergency procedures and increase symptomatic patient testing.

 

While we are scaling up our manufacturing operations as quickly as possible, demand for the cobas® SARS CoV 2 & Influenza A/B assay will outpace supply. As a result, Roche temporarily has paused new contracts for the cobas Liat system to ensure that we are able to continue to supply our existing cobas Liat customers with non-COVID-19 tests, while still meeting pandemic needs with the new cobas SARS-CoV-2 & Influenza A/B test.

The ultimate price a patient will pay is determined by many factors, including what the lab charges for the test and what insurance will cover. Roche believes cost should not be a barrier to accessing diagnostics, and we certainly price all tests responsibly.

This is a diagnostic test that is ordered by a healthcare professional and is not available for home use. Please contact your healthcare provider for more information.

Patient samples are taken using either a nasopharyngeal or nasal swab. Patients can also self-collect nasal samples under the supervision of a healthcare professional.

We are evaluating options for other POC tests, including a SARS-CoV-2 Rapid Antibody Test and a SARS-CoV-2 Rapid Antigen test. On July 28, 2020, Roche launched the SARS-CoV-2 Rapid Antibody Test in markets accepting the CE Mark. We are currently determining the path forward on additional POC tests in the United States.

 

 

Elecsys<sup><sup>®</sup></sup> Anti-SARS-CoV-2 S FAQs

Elecsys® Anti-SARS-CoV-2 S FAQs

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the Roche Elecsys® Anti-SARS-CoV-2 S antibody test. This semi-quantitative serology (blood) test can be used to measure antibodies in people who have been exposed to the SARS-CoV-2 virus. Tests like these can provide critical information to help healthcare professionals evaluate whether a potential vaccine induces a sufficient immune response.

The new test targets antibodies that are directed against the region of the novel coronavirus known as the spike protein, specifically the area that enables the virus cell to bind to the host cell receptor, which is required for the virus to enter the host cell. Many current candidate vaccines aim to induce an antibody response against this spike protein.

The Elecsys® Anti-SARS-CoV-2 test targets the nucleocapsid protein and is a qualitative test 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. The Elecsys® Anti-SARS-COV-2 S test targets the spike protein and provides a semi-quantitative result that measures the level of antibodies present in the sample.

This test uses plasma or serum to determine the presence of antibodies associated with exposure to the SARS-CoV-2 virus. From patients, blood samples drawn by healthcare professionals are required, similar in size to samples drawn for common lab tests.

The laboratory-based test runs on Roche’s widely available cobas e analyzers—cobas e 411, cobas e 601/602, or cobas e 801. 

The fully automated cobas e analyzers can provide SARS-CoV-2 antibody test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the analyzer.

The test has both a high clinical NPA of 99.98% (N=5991) and PPA of 96.6% (N=233), 15 days or later after diagnosis with PCR. Additionally, across panels of potentially cross-reactive samples (N=1100) from endemic human coronaviruses, infectious respiratory diseases, other infectious diseases, auto-immune and liver related diseases, the test demonstrated zero cross-reactivity.

 

 

SARS-CoV-2 Rapid Antigen Test FAQs

SARS-CoV-2 Rapid Antigen Test FAQs

This lateral flow test detects virus proteins to identify active SARS-CoV-2 infection. A healthcare provider uses a nasal swab sample collected from the patient's nose.

The test is administered by healthcare professionals and labs in various traditional and non-traditional point-of-care locations; such as: physician offices, community pharmacies, urgent care centers, hospitals, congregate settings like sporting events or churches, public health labs, long term care facilities, nursing homes, and school or corporate healthcare clinics.

The test is administered by healthcare professionals and labs. These labs must be certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate or high complexity, or waived tests.

The test uses a simple nasal swab sample and comes in a small, convenient kit that does not require laboratory instruments.

The test is to be administered by healthcare professionals and labs only, as an aid in detection of SARS-CoV-2 infection in individuals suspected of COVID-19 with clinical symptoms onset within 5 days.

Results are typically ready in as little as 15 minutes for people with symptoms of COVID-19.

Roche expects to have tens of millions of SARS-CoV-2 Rapid Antigen Tests available per month in the United States at launch, with the capacity to produce additional volumes as needed to help address pandemic testing demand.

The ultimate price a patient will pay is determined by many factors, including what the lab charges for the test and what insurance will cover. Roche believes cost should not be a barrier to accessing diagnostics, and we certainly price all tests responsibly.

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. If you are a medical or healthcare professional, please contact your Roche sales representative or distribution partner for more information on how to obtain the test.

The test uses a nasal swab sample collected from the paitent's nose - allowing for quick and convenient collection and minimally-invasive testing experience for patients.

You can find this on our product page here.

Roche has analyzed the sequences from the SARS-CoV-2 variants identified in the United Kingdom, South Africa and Japan (Brazil), comparing the mutations to the design of our SARS-CoV-2 Rapid Antigen Test, SARS-CoV-2 Rapid Antibody Test, Elecsys® Anti-SARS-CoV-2 assay, Elecsys® Anti-SARS-CoV-2 S assay, and Elecsys® SARS-CoV-2 Antigen assay. Based on this analysis, we do not anticipate that the currently genotyped SARS-CoV-2 variants, including B.1.351(501.V2) and B.1.1.7, will impact the performance of our tests. For more information please reference our customer letter here. 

Yes, the rapid antigen test can be used if someone has been vaccinated as the vaccine will not impact the test. The vaccines elicit an immune response that is targeted to a specific part of the virus. The Roche rapid antigen test targets a different part of the virus and has the capability of detecting the presence of virus in an infected individual, even if vaccinated.

We are currently evaluating additional sample collection type options for the SARS-CoV-2 Rapid Antigen Test, and determining our path forward on additional COVID-19 POC tests in the United States.