It is a messy situation in the United States in terms of detecting the COVID-19 infection in the patients. The US officials did not have any testing equipment when the symptoms of the illness were shown in the US citizens. The US health officials developed several testing techniques in a span of a few weeks to detect the virus.
The Food and Drug Administration (FDA) of the US received almost 230 emergency authorization requests from different test developers. The FDA has already granted the authorization to 20 test developers. According to the FDA, around 110 laboratories across the country are using their own tests. It is a great achievement to develop hundreds of diagnostic tests in a very short time.
It is not completely clear at the moment which tests are good and which tests are bad. The FDA released a press release on March 30 in which the administration said, “The FDA revised the process to allow labs to begin testing prior to FDA review of their validation data.” The FDA added that they made the decision to expand the access of the US residents to the diagnostic testing.
The FDA guided the laboratories to present some evidence of the performance of their assay. The administration asked the test makers to show some proof of the consistency in their assay’s results. The approval of the test is dependent on the revision of the assay’s performance by the FDA. The US health officials and scientists have been working hard to develop diagnostic tests.
A lot of things still needed to be learned
The COVID-19 infection is caused by the SARS-CoV-2 virus. The novel virus was first identified in Wuhan, China, in November 2019. The health scientists believed that the virus first infected animals and then exhibited by humans. The zoonotic origins of these viruses help them to transfer from person to person. The spread of the COVID-19 between humans makes it different from other coronaviruses.
There is a lot to be learned about the virus yet. The health scientists develop antibodies for most of the respiratory viruses. These antibodies protect the patients from getting infected again by these viruses. It is related to immunity. The assumption of the scientists is that they would develop immunity from having being exposed to COVID-19 infections. There is a lack of certainty in this regard in the mind of health scientists.
There are a lot of questions with unknown answers at the moment. Will this virus become seasonal? Will this virus mutate? Only time can tell us the answers to these questions. The first milestone for the US health scientists was to develop the test for detecting this virus. It was the only way to reduce or stop the spread of the virus in the US.
The isolation of the infected people in the early stages can reduce the transmission of the virus to others. The US market has at least 22 COVID-19 tests at the moment. The tests developed by the individual laboratories across the US are not included in them. You must be wondering why do we need so many tests?
Why do we need so many tests?
Most of the COVID-19 tests are based on the collection of the RNA (ribonucleic acid) of the virus and converting it into the DNA (deoxyribonucleic acid). The same method has been used in all tests available at the moment. The next milestone for the test developers is to make millions of copies of the DNA so that it would be detected easily.
The difference among these tests come at the stage of converting the RNA to the DNA. The COVID-19 virus can be detected from many different genetic sections as it is a large virus. The difference comes when a test target one or more genes while the other test targets other genes. The test specifications for the detection of the COVID-19 have been developed by the World Health Organization (WHO) in January 2020.
The test specifications developed by the Centers for Disease Control and Prevention developed in February 2020 were different from the WHO’s specifications. The CDC was the one and only testing center in the US in the beginning. The rise in the demand for the tests pushed the CDC to distribute the tests to public health laboratories across the US.
Three small sections of the genetic material of the virus were probed by the CDC to develop the first test. The testing kits manufactured and distributed by the CDC started causing problems within a few days. Most of the problems were caused due to the impurities in the testing material. The tests started giving faulty results.
The FDA stood strong to follow its decision of not allowing the hospitals, academic centers, and companies to develop their own tests until the end of February 2020. After the lifting of the regulations, the health centers across the country started developing their own COVID-19 tests. It happened due to the spread of the virus at a quick pace in the US and an increase in the demand for the tests.
The hospitals, academic centers, and laboratories were left to use their own devices to carry out the detection tests. The FDA could not settle upon a single standard for detecting the COVID-19 infection in the body of the infected patients.
Which test is right? Which one is wrong?
There is not any certain answer in this regard. But everyone is still wondering about which one is a good test? All of these tests are new and the performance of these tests can only be judged with the passage of time. The health institutions and centers have been using different tests at a time. All of these tests have different performance characteristics. It is impossible to answer the questions about the viability and effectiveness of the tests at the moment.
The huge demand for the tests is enforcing the testing centers to use different testing kits at a time. All of these tests have been developed in a quick time. It is certain that they will not have the same performance characteristics. We need to hope that all of the available assays should perform well.
COVID-19 testing being regulated by FDA
Most of the US laboratory directors have a relationship of love and hate with the FDA. The love the administration as it provides oversight to protect them from using poor products or products that do not work. On the other hand, they have the administration due to its stiff standards. These standards have been pushing the US behind. Many products come into the European and Canadian markets much early than the US markets.
COVID-19 testing has been regulated by the FDA in a very different way. The administration allowed the hospitals, laboratories, and academic centers to develop their own tests when it saw a huge rise in the demand for the tests. The FDA approved the tests that fulfilled the minimal standards. The FDA will surely evaluate the tests in the upcoming days. Until then, many tests will be used in the US that does not fulfill the usual high standards of the administration.