The COVID-19 pandemic has placed a huge burden on the healthcare industry. Your agency should try to ensure that any investments you are making in tools to fight this crisis are in the best interests of your healthcare organization. One major factor you need to consider is the COVID-19 test kits themselves. Genesis Medical Management, the leader in healthcare innovation, wants to ensure that you are knowledgeable about the current available testing for SARS-CoV-2 and making the right decisions for your healthcare company before purchasing any test kits.
The last thing your entity wants to do is invest in test kits that are not accurate or do not provide the information you are seeking. First you must decide whether you are looking for viral or antibody tests, or both. Viral tests, both nucleic and antigen, are used to diagnose the presence of SARS-CoV-2 infections. Antibody tests, on the other hand, can detect IgG, IgA, and IgM antibodies from an immune response to SARS-CoV-2, to help determine whether a patient previously was infected with COVID-19.
Laboratories and doctors must be aware that a negative result from viral testing does not rule out COVID-19. Many of the PCR base tests that use two or more targets are likely to have high specificity, in other words they should give very few false positives. However, there is some variation in the stated sensitivity of the different assays, and sensitivity is highly dependent on the stage of the disease. So, any negative results should be interpreted in the context of exposure history and symptoms of the patient.
Antibody testing should not be used to diagnose or exclude SARS-CoV-2 infections, or to inform infection status. Negative results do not rule out SARS-CoV-2 in patients who have been exposed to the virus and are still within the incubation period. It is even possible that positive results from antibody testing may be due to past or present infections with a coronavirus other than SARS-CoV-2. If a laboratory is going to use antibody testing for diagnostic purposes, they should always conduct follow-up viral testing.
One of the largest concerns when purchasing tests is to ensure it has been evaluated and approved by the Food and Drug Administration (FDA). There are several tests on the market that have not been evaluated or approved by the FDA. You can obtain a list of the FDA’s authorized tests, including serological tests, on the FDA’s Emergency Use Authorization (EUA) page. There you can find a list of all approved tests and their accuracy levels. Unfortunately, there are many entities that are marketing serological tests with false claims that they are FDA approved. Take the time to research the validity of those claims before purchasing any tests.
Another scam that is currently occurring involves the cost for the tests. All test kits should be free or covered by insurances. Beware of anyone charging for tests and any middleman commissions that may be occurring. Do not be taken in by any short-term profit scams.
Genesis Medical Management, your healthcare solutions experts, wants to ensure that your healthcare organization is making the best decisions you can with the proper information. We provide healthcare innovations that will ensure your company’s success.
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