Roche Elecsys Anti-SARS-CoV-2 Antibody Test Goes Live at More than 20 Initial Lab Sites in US
By HospiMedica International staff writers Posted on 28 May 2020 |
Illustration
Roche’s (Basel, Switzerland) Elecsys Anti-SARS-CoV-2 antibody test is currently live at more than 20 commercial and hospital lab sites throughout the US, with plans in the next several weeks to increase to more than 200 commercial and hospital lab sites with the ability to perform millions of tests per week.
The Elecsys Anti-SARS-CoV-2 antibody test, which received Emergency Use Authorization from the FDA earlier this month, is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, indicating whether a person has already been infected and potentially developed immunity to the virus. Uniquely designed to identify mature (high affinity) antibodies developed late in the immune response, the Elecsys Anti-SARS-CoV-2 test has 99.8% specificity and shows no cross-reactivity to the common cold, HIV and other coronaviruses. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual. The test detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.
Roche has more than 3,000 analyzers that perform the antibody test installed across the US. The company is distributing millions of tests per week to US labs that can implement quickly, enable the broadest geographic reach and provide testing to areas hardest hit by COVID-19. Roche is also working to meet demand by scaling global production rapidly in an effort to expand broader access as quickly as possible.
“Roche is proud to make this highly accurate serology test available in the U.S. to determine if a person has developed antibodies to COVID-19,” said Matt Sause, President and CEO of Roche Diagnostics North America. “Reliable, high-quality antibody testing is essential to help us overcome this pandemic and will play an important role in getting people back to work. We are proud to partner with LabCorp in making this test available in the U.S.”
“Our long-standing relationship and collaboration with Roche enables us to introduce many innovative, high-quality tests for clinicians and patients, which is more important now than ever before,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “Roche’s new antibody test allows LabCorp to provide more options and increase COVID-19 testing capacity as we support the country’s response to the health crisis.”
The Elecsys Anti-SARS-CoV-2 antibody test, which received Emergency Use Authorization from the FDA earlier this month, is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, indicating whether a person has already been infected and potentially developed immunity to the virus. Uniquely designed to identify mature (high affinity) antibodies developed late in the immune response, the Elecsys Anti-SARS-CoV-2 test has 99.8% specificity and shows no cross-reactivity to the common cold, HIV and other coronaviruses. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual. The test detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.
Roche has more than 3,000 analyzers that perform the antibody test installed across the US. The company is distributing millions of tests per week to US labs that can implement quickly, enable the broadest geographic reach and provide testing to areas hardest hit by COVID-19. Roche is also working to meet demand by scaling global production rapidly in an effort to expand broader access as quickly as possible.
“Roche is proud to make this highly accurate serology test available in the U.S. to determine if a person has developed antibodies to COVID-19,” said Matt Sause, President and CEO of Roche Diagnostics North America. “Reliable, high-quality antibody testing is essential to help us overcome this pandemic and will play an important role in getting people back to work. We are proud to partner with LabCorp in making this test available in the U.S.”
“Our long-standing relationship and collaboration with Roche enables us to introduce many innovative, high-quality tests for clinicians and patients, which is more important now than ever before,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics. “Roche’s new antibody test allows LabCorp to provide more options and increase COVID-19 testing capacity as we support the country’s response to the health crisis.”
Latest COVID-19 News
- Low-Cost System Detects SARS-CoV-2 Virus in Hospital Air Using High-Tech Bubbles
- World's First Inhalable COVID-19 Vaccine Approved in China
- COVID-19 Vaccine Patch Fights SARS-CoV-2 Variants Better than Needles
- Blood Viscosity Testing Can Predict Risk of Death in Hospitalized COVID-19 Patients
- ‘Covid Computer’ Uses AI to Detect COVID-19 from Chest CT Scans
- MRI Lung-Imaging Technique Shows Cause of Long-COVID Symptoms
- Chest CT Scans of COVID-19 Patients Could Help Distinguish Between SARS-CoV-2 Variants
- Specialized MRI Detects Lung Abnormalities in Non-Hospitalized Long COVID Patients
- AI Algorithm Identifies Hospitalized Patients at Highest Risk of Dying From COVID-19
- Sweat Sensor Detects Key Biomarkers That Provide Early Warning of COVID-19 and Flu
- Study Assesses Impact of COVID-19 on Ventilation/Perfusion Scintigraphy
- CT Imaging Study Finds Vaccination Reduces Risk of COVID-19 Associated Pulmonary Embolism
- Third Day in Hospital a ‘Tipping Point’ in Severity of COVID-19 Pneumonia
- Longer Interval Between COVID-19 Vaccines Generates Up to Nine Times as Many Antibodies
- AI Model for Monitoring COVID-19 Predicts Mortality Within First 30 Days of Admission
- AI Predicts COVID Prognosis at Near-Expert Level Based Off CT Scans