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Testing for 2019 Novel Coronavirus (SARS-CoV-2) COVID-19
by Polymerase Chain Reaction (PCR)
COVID-19 Laboratory-Based Testing
The Centers for Disease Control and Prevention recently broadened the guidelines for coronavirus testing. Anyone who has symptoms like a fever, cough, or difficulty breathing can receive a test if a doctor agrees. Doctors are encouraged first to rule out other causes of respiratory illness, like influenza, and to take into consideration whether there are other local coronavirus cases. Coronavirus testing looks for signs of infection in nasal secretions, or other body fluids using real-time RT-PCR. The test is directed to detect and identify the 2019 Novel Coronavirus.
How does COVID-19 Testing work
Omega Laboratories performs Polymerase Chain Reaction testing, or PCR, utilizing the LumiraDx SARS-CoV-2 RNA STAR to identify the presence of the 2019 Novel Coronavirus (SARS-COV-2) COVID-19. Utilizing a nasal swab (nasopharyngeal), this testing multiplies copies of converted DNA found within the specimen and is analyzes them to determine whether or not the COVID-19 virus is present within the specimen. This process tests for active infection, which means that this testing is designed to determine if patients are currently infected with COVID-19.
Omega PCR Testing for COVID-19 Variants
The United States Food and Drug Administration (FDA) recently announced concerns that new coronavirus variants may cause certain PCR testing systems to return false-negative results. The FDA has noted that “diagnostics made by Applied DNA Sciences, Mesa Biotech and Thermo Fisher Scientific may be affected by the variant.” Omega Laboratories currently uses LumiraDx SARS-CoV-2 RNA STAR, an assay that is confirmed to pick up COVID-19 variants without issue. Please rest assured that Omega Laboratories’ PCR testing is capable of providing you with proper detection and reporting of COVID-19 and its variants. In these uncertain times, you can count on the quality and accuracy of Omega Laboratories for your organization's COVID testing needs. For more information on the FDA's concerns, please see "FDA flags COVID-19 false negative risk from virus variant of Thermo Fisher, Applied DNA and Mesa tests."
COVID Testing Program Information
Omega Laboratories is uniquely capable of managing your COVID testing needs. Our dedicated clinical laboratory staff is committed to providing you with the highest level of service, including high sensitivity, industry-leading turnaround times, and high-quality client service. In these uncertain times, you can count on Omega Laboratories' quality for your organization's COVID testing program.
Individuals should be considered for active infection testing if they are experiencing COVID-19 symptoms or if they believe that they were exposed to the virus within the last two weeks. Symptoms of COVID-19 include cough, fever, shortness of breath, difficulty breathing, sore throat, and muscle weakness. If a donor meets any of these criteria, you should consider having them take a COVID-19 Active Infection test.
Nasopharyngeal & Nasal Mid-Turbinate Specimens
Omega recommends the use of Nasopharyngeal (NP) specimens as the standard for COVID-19 PCR testing, as nasopharyngeal collections provide the best specimen when looking to detect the presence of coronavirus in a patient. For this reason, nasopharyngeal collections are the gold standard in clinical practice and for any mission critical testing. However, Omega’s PCR testing can also utilize nasal mid-turbinate (NMT) collections performed using a full swab insert. Omega’s testing of mid-turbinate collected specimens is also covered under the FDA Emergency Use Authorization (EUA) for our PCR testing. Mid-turbinate testing is most suitable for surveillance testing of individuals who are not symptomatic and who are not suspected to be positive due to exposure. Mid-turbinate collections can be performed using the same swab and vial we distribute for nasopharyngeal collections.
How Does Omega Compare
Omega Laboratories uses laboratory-based techniques and PCR technology. Analysis is performed using the and Applied Biosystems® 7500 Fast DX systems. Omega's testing utilizes proven production-laboratory processes to provide results within 24-48 hours, with most specimens reporting out within 24 hours. Omega's testing is cutting edge, high throughput, high sensitivity, and has FDA Emergency Use Authorization (EUA) specific to COVID-19 testing.
Methodology
Omega Laboratories uses rt-PCR technology, a highly reproducible method designed for the qualitative detection of nucleic acid from SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal and oropharyngeal swabs) collected from individuals suspected of COVID-19 by their healthcare provider. Sensitivity is 7.5 copies per ul. For more information on the Selectivity / Specificity of our testing, please see our Emergency Use Authorization (EUA)
Severity
The complete clinical picture with regard to COVID-19 is not fully known. Reported illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death. While information so far suggests that most COVID-19 illness is mild, a report out of China suggests serious illness occurs in 16% of cases. Older people and people of all ages with severe chronic medical conditions — like heart disease, lung disease and diabetes, for example — seem to be at higher risk of developing serious COVID-19 illness. A CDC Morbidity & Mortality Weekly Report that looked at severity of disease among COVID-19 cases in the United States by age group found that 80% of deaths were among adults 65 years and older with the highest percentage of severe outcomes occurring in people 85 years and older.
COVID-19 Testing Program: Frequently Asked Questions (FAQs)
What is PCR?
Polymerase chain reaction (PCR) is a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail.
Do you have FDA Emergency Use Authorization (EUA)?
Yes, the Emergency Use Authorization (EUA) can be found here.
How do you collect specimens for COVID-19 testing?
For instruction on proper nasopharyngeal and mid-turbinate collections for COVID-19 specimens, please see our COVID-19 Collection Training
Will Active Infection testing detect antibodies?
Active infection testing is designed to target active infection with the 2019 Novel Coronavirus (SARS-COV-2) COVID-19. As such, it will not detect antibodies or previous infection of COVID-19.
What is the turnaround time for your COVID-19 tests?
Omega Laboratories currently offers 24-48 hour turnaround time on COVID-19 testing, with testing and reporting being performed Monday-Friday.
Do you offer oral fluid / saliva testing for COVID-19?
Omega does not offer oral fluid testing for coronavirus at this time, though we are in the process of developing COVID testing using oral fluid (saliva) specimens.
Can you use our existing collection supplies?
Omega is capable of using a variety of different collection swabs kits. If you have existing kits that you would like to use, please contact us and we will see if we can accomodate your request.
How many tests can you perform?
Omega Laboratories is currently capable of performing 4,000 COVID-19 tests daily, with the added ability to quickly scale operations to meet additional testing volume needs.
Interested in setting up a COVID-19 Testing Program?
Simply send us a message or give us a call and a member of our team will be delighted to help in any way we can.
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