How Do They Test for COVID 19?
The process is complicated, and most of us don’t even think about how medical tests in normal conditions. Conditions are not typical, and it won’t be for some time. COVID testing is on the news every hour of every day, making sure everyone is wondering about testing.
Who Regulates Testing?
The Food and Drug Administration, Centers for Disease Control, and the Department of Health & Human Services are all involved in the regulations, approvals, and processes for COVID testing. It is complicated, especially since testing needed to expand quickly, safely, and accurately.
Of course, there are also state, local, and tribal governments involved to execute the guidance of the Federal Government Agencies! Then hospitals, clinics, laboratories, and in some cases, local pharmacies. What could go wrong?
There is a “Testing Blueprint” written by the FDA and CDC titled “Opening up America Again” and published by the Whitehouse with guidance for testing plans and rapid response plans.
Testing Roles & Responsibilities
TESTING ROLES AND RESPONSIBILITIES This Blueprint describes a partnership between Federal, State, local, and tribal governments, along with the private sector and professional associations, to continue to meet the country’s testing needs. The general areas of responsibility within this partnership are:
- Publish guidelines for Opening Up America Again and provide a Blueprint for the testing plans and rapid response programs called for by those guidelines.
- Provide strategic direction and technical assistance regarding the best use of available testing technologies.
- In partnership with States, strategically align laboratory testing supplies and capacity with current and anticipated laboratory needs.
- Provide expedited regulatory authorizations for tests and testing equipment.
- Publish and update procedural guidance for administering diagnostic tests (i.e., prioritization algorithms and protocols). OPENING UP AMERICA AGAIN
- In partnership with the private sector, accelerate research and development of innovative diagnostic tests (e.g., rapid, non-invasive Point-of-Care (POC) tests).
- Identify and share best practices and provide technical assistance to State, local, and tribal governments to improve their testing, surveillance, and contact tracing programs.
- Act as the supplier of last resort.
State, Local, and Tribal Governments
- Develop testing plans and rapid response programs, as called for by the President’s Guidelines.
- Maximize the use of all available testing platforms and venues (e.g., private, public, hospital, clinic-based laboratories).
- Identify and overcome barriers to efficient testing (e.g., underutilization of deployed assets, misallocation of supplies, logistical failures).
- Develop and implement sentinel monitoring and rapid response programs.
Private Sector and Professional Associations
- Develop new technologies.
- Seek emergency use authorization (EUA) for new technologies, as appropriate.
- Accelerate production of tests and materials (e.g., swabs).
- Share data and information from clinical trials with other stakeholders.
- Expand testing partnerships with State, local, and tribal governments.
Translating Government Speak on How Testing is Done
As a layperson that is amazed at the technology that goes into medical testing, it is easier for me to understand a simpler version of what happens during the testing process.
Some of those medical experts we all keep hearing about must:
- Understand where the disease came from
- How the virus is transmitted.
- Decide what is different in our bodies
- Where to find those differences in our bodies
- Devise a way to test for indicators of the disease in our bodies
- Create a test kit of ingredients to capture those indicators
- Device a way to conduct the tests
- Determine what test equipment for COVID 19
- What a positive or negative test results look like
- Create materials for the test
- Devise a way of using those materials to test
- Determine what equipment can evaluate the tests
Paraphrasing the FDA Article, the two types of FDA authorized tests are Diagnostic and Antibody Tests.
- The diagnostic test can show if you have an active infection and should take steps to isolate your self from others. There are two types of these tests called molecular and antigen tests. One detects the virus’s genetic material in the body during the second specific proteins on the surface of the virus.
- An antibody test looks for antibodies that are made by the immune system in response to the virus. These antibodies that fight the infection lasts for weeks in the body after recovery that lets us know that we had the disease and may have recovered already.
No, I do not know what an antibody looks like or how I would find one. Fortunately, someone smarter than me does.
There are different ways of collecting samples for these tests. My favorite is the swab up my nose. It leaves no doubt about how far my nasal cavity goes straight up into my head. It amazes me that there are pain and tickle receptors up there where no one should be sticking something anyway.
How Do They Evaluate Test Samples?
There are guidelines for transporting the sample to a laboratory —they need to get to the lab within 72 hours and must be maintained within specific temperature ranges. At the laboratory, more FDA approved chemicals are mixed with the samples based on what equipment and what type of test.
The lab technician mixes chemicals with the swap to extract genetic material. Then they use other chemicals and a high tech machine to conduct heating and cooling cycles that convert the virus’s RNA to DNA. The difference between the two NAs.
What possibly could go wrong with this process? Many things from the collection, transportation, additional chemicals, and time frames. We have come to depend on the sophisticated technology used in equipment to provide accurate results. Still, like all technology, things can go wrong with the equipment, maintenance, and operator errors. With more than 50 million tests conducted in the US so far, what percentage of those tests are not accurate? That number isn’t discussed on the nightly news.
The other types of laboratory tests for detecting the virus in samples also require sophisticated technical testing equipment. FDA emergency use authorization covers many different types of testing equipment. The volume of tests in such a short period is unprecedented.
In most cases, the laboratories utilizing the equipment have been previously approved for use in detecting other types of influenza or recently approved by their state public health laboratory for SARS-CoV-2 testing.
Just a note COVID 19 is named 19 because it originated during the year 2019. CO stands for ‘corona’ VI for ‘virus, and D for the disease.
The Laboratory Test Equipment
The actual machines that test or assay the samples in the laboratory are incredibly complex. Accuracy and productivity are high on the lists of must-have when labs chose the right equipment for clinical chemistry and immunoassay equipment. Most labs are not equipped for the volumes of samples demanded by widespread testing.
Many manufacturers have stepped up to improve the operational efficiency of their equipment and integration with data systems to track results. I’d like to explain all the stuff that is necessary and how it works, but I’m afraid it is all over my head and most people of the world outside the medical professions.
There are online sources that offer better explanations and how the equipment works.
- rRT-PCR Reagents
- Realt-time PCR Detector Systems
- Nucleic Acid Extraction Systems
- PCR Work Stations
The following companies manufacture either COVID-19, SARS-Cov-2, SARS-CoV-2 antibody testing equipment, and kits according to this Labcompare Article.
- Abbott Laboratories
- Hamilton Company
- Henry Schein, Inc
- Impact Health
- Millipore Sigma
- Premier Medical Laboratory
- Scanwell Health
- Sorrento Therapeutics
We have all these companies and hundreds more debt of thanks for coordinated effort worldwide to enable testing and research for cures of the current virus. The mobilization on a global scale has been astonishing.
Manufacturing Equipment Used for Testing?
Engineering, precision, and quality components that provide accuracy and reliability during thousands of testing cycles are required. The best engineers and medical minds collaborate to make this equipment possible for everyday use.
Imagine even the best equipment designs are only as good as the parts that go into the design. That is where suppliers of precision manufactured components come into play. DBK USA is one of those suppliers of micro-heating and cooling solutions that support the medical equipment industry.
Thermal management is essential during the processing of samples and the high-value materials used during the process from sample to result. Precision is especially important when precise temperature cycling is required to activate the regents and stimulate inflammatory responses.
Industrial Thermal Management
In many cases such as the medical testing equipment for COVID, the required temperatures can not vary or can’t exceed a certain temperature. This where heating components such as PTC ceramic heating elements or thermoelectric coolers come into play. The quality and precision of these components are utilized in many industries outside of life science and medical laboratories.ITM is a technical term for managing the temperature of a device or process in an industrial setting. Thermal management is what you do in your own home to remain comfortable throughout the year of changing seasons. The same is true for an industrial process or device, but usually, the required tolerances or temperatures are more precise.
- 3D Printing
- Food & Beverage
- Power & Gas
Do you have a unique application requiring specialized thermal management? DBK engineers are available for consultation at 1-864-607-9047.Customized flexible heaters that are thin and lightweight while moisture and chemical resistant are used in our space programs and military weapons design.