CoreMedica Implements ROCHE EUA Authorized Antibody Test for COVID-19
June 12, 2020 — Lee’s Summit, MO.
CoreMedica Laboratories, Inc., announced today the implementation of the Roche Elecsys Anti-SARS-CoV-2 antibody test. This new test offers a unique complementary tool to our current high sensitive ELISA method for IgG and IgM antibody detection. CoreMedica is currently the only laboratory offering COVID-19 serology confirmations via a secondary ELISA based antibody detection method. This strategy is crucial to determine reliably if a person has been exposed to the virus and has developed antibodies. Tests with lower specificity and sensitivity can lead to a high number of misidentified cases in a population. This is particularly problematic when the prevalence of viral infections are relatively low such as the current situation in the United States and other countries. A false positive result may put a patient at risk by inaccurately indicating they have developed antibodies and potentially giving the false security of protection against future exposure to COVID-19.
The Roche Elecsys Anti-SARS-CoV-2 antibody test is designed to identify mature, high affinity antibodies, significantly reducing the chance of a false positive result. It provides 99.8 percent specificity, which is greater than previously available antibody tests. As a result, the combination of both testing platforms will allow CoreMedica to perform a fast initial screening on automated analyzers using Roche, and verify the specific reactivity for IgG and IgM antibodies on positive samples using ELISA. This specificity is crucial to determine reliably if a person has developed antibodies to COVID-19 following an exposure to the virus. Our long-standing relationship and collaboration with Roche Diagnostics enables us to introduce many innovative, high-quality screening tests for all clients located at different business segments.
“CoreMedica is proud to offer this highly accurate serology test to determine if a person has developed antibodies to COVID-19,” said Cory Zuehlsdorf, Founder and Director North America of CoreMedica. “Reliable, high-quality antibody testing is essential to help us monitor and overcome this pandemic and will play an important role in getting people back to work and school. We are delighted to work with Roche and offer their valuable Elecsys Anti-SARS-CoV-2 antibody test to our clients.”
The Roche Elecsys Anti-SARS-CoV-2 immunoassay is authorized for the detection of antibodies to SARS-CoV-2 in human serum or plasma. This test measures human SARS-CoV-2 antibodies that are generated as part of the initial immune response and adaptive human immune response to the virus and is to be performed only using serum or plasma specimens.
- The Elecsys Anti-SARS-CoV-2 immunoassay can be used to test human serum or plasma (Heparin, EDTA).
- The United States FDA has made this test available under an emergency access mechanism called an Emergency Use Authorization (EUA200514/A001). The EUA is supported by the Secretary of Health and Human Service’s (HHS’s) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19.
Serological tests for SARS-CoV-2 are intended for individuals who may have been exposed to COVID-19, whether they are symptomatic or not. It has been shown to be effective in identifying silent carriers when coupled with rapid viral testing in IgM positive individuals. Understanding if an individual has developed antibodies and a potential immune response can be useful in the determination of important decisions such as the ability for business to monitor their staff during economic reopening across the country. The graph shows the actual number of new cases each day since laboratory testing became implemented in March 2020.
We advise all of our clients to remain informed and plan any future Health Awareness activities with caution and taking into account the relative risk depending on the geographic location where future events have been scheduled during re-opening efforts. CDC statistics indicate the current prevalence at 11%, nonetheless, this number is highly biased by hot spots located in New York, Louisiana, Texas, and Florida.
Along with traditional venous specimens, CoreMedica also offers this test in a convenient fingerstick dried capillary blood method. The dried blood option is being provided as a laboratory developed test, and uses the same Roche platform which received Emergency Use Authorization by the U.S. Food and Drug Administration. CoreMedica completed independent validation studies on this testing. Dried blood specimens are also suitable for IgG/IgM confirmation.
About CoreMedica Laboratories, Inc.
CoreMedica is a diagnostic services company with operations in the US and EU. Founded 2010 in Lee’s Summit, Missouri, CoreMedica Labs spent its initial years developing the science, validating its methods, and implementing compliance to obtain College of American Pathologists (CAP) Accreditation and the Clinical Laboratory Improvement Amendments (CLIA) License. CoreMedica US is the first dried blood laboratory to receive CAP accreditation in 2014. The company provides a range of diagnostic services for corporate wellness, research, and pharmaceutical clients. In 2018 CoreMedica expanded its activities to Geneva, Switzerland to add the biological passport and innovative new technologies and advanced intellectual property to its portfolio of services.
CoreMedica’s current specimen analysis capabilities span across multiple collection modalities and methods, fingerstick, or venipuncture. Specimens from all across the world are processed at both of its United States (US) and European Union (EU) site laboratories daily. Its geographic footprint allows for industry leading turn-around time, consistency and quality.
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