America’s response to the novel coronavirus has been hampered by the shortage of testing kits, killing nearly 82,000 people and infecting more than 1.7 million individuals. Conduct of widespread antibody and diagnostic testing to identify virus-infected individuals will shape the actions of the US government and its local authorities.
Testing is imperative to address the worry and doubt of the public. It will help the government address the issues of treating patients, pandemic related policies, resource allocation, and many more. That said, if testing is invaluable, why was not the US prepared to perform tests rapidly, even before the novel coronavirus hit the country?
With the risk of a second wave of COVID-19 infections, could the United States once again be vulnerable and unprepared?
About two weeks after the novel coronavirus hit the United States, the Trump Administration issued a public health emergency. Later on, the Food and Drug Administration (FDA) granted an emergency use authorization to the Centers for Disease Control and Prevention (CDC).
However, according to many experts, the country was already behind in action right from the start. Harry Glorikian, a general partner at Venture Funds, noted that other than the CDC, the only ones who were allowed to create tests for the virus were diagnostic test makers. This action was said to be the reason for the country’s lag.
Public health laboratories were not given a chance to participate in the process of creating tests. Upon facing the spread of the virus and pressure from laboratory organizations and the problems with the CDC tests, the FDA later altered its guidelines and permitted CLIA-certified laboratories to develop their own tests.
Even with these efforts, by this time, the demand for testing kits already surpassed the supply, making it difficult for medical professionals to single out and isolate patients. According to Jack Meehan’s research note, a former analyst at Barclays, the testing capacity at the start of the virus outbreak was not enough.
Also, Jack Meehan noted that insufficient testing options implied that public health officials could not contain the disease’s spread. The test developed by CDC was instantly followed by others, most of which used Polymerase Chain Reaction (PCR) to discover viral nucleic acid.
The approved tests, later on, contained antibody-based serology tests. Currently, there are seventy FDA-certified tests on the market, and about twenty-four molecular-base lab-developed tests have emergency use authorization.
The two dozen tests can only be used in the laboratories that created them. Moreover, because of the demand for the testing kits, developers are required to work overtime. Also, the number of tests they need to conduct is overwhelming.
Another complication at the beginning of the outbreak was finding and hiring knowledgeable personnel for the laboratories. One reason that puts a strain on laboratory technicians are tests that run on semi-automated or manual systems.
Test developers are struggling with shortages of swabs, reagents, and other collection devices. Carmen Wiley, President of the American Association for Clinical Chemistry (AACC), said supply issues were a massive predicament for AACC members. As a result, many people tend to buy coronavirus test kits online, which might have a low-reliability rate.
Also, some laboratories have started certifying alternate transport media and are utilizing 3D printers to build and produce nasopharyngeal collection swabs. Because many test kits are being set aside based on the anticipated need, some laboratories can run more tests. However, they do not have the necessary reagent kits needed for a full-blow test process.
Moreover, AACC President Wiley said that there are more laboratories with the capacity to run at least 1,300 tests every day. However, they have only collected 800 kits from the developers. Reagent producers, like test developers, are giving their all to increase the supply, but it is still not enough for the public.
Reagent producers like Qiagen expect to ramp up their production capacity to support testing for about 6,500,000 patients every month ever since April. The firm anticipates supporting approximately 10,000,000 at the end of June.
Mass Testing Can Help
It is challenging to diminish the pandemic’s effects. An epidemiologist at Duke University, Gregory Gray, explained that even though the COVID-19 is spreading too rapidly. He added that most epidemics we’ve seen so far in various countries are infecting only a small portion of the overall population.
No matter where people live, they will still be vulnerable in any area. The enormity of this problem plus the risk of having hundreds of thousands of people getting infected at the same time is the main reason why many countries deploy rigorous drastic measures, such as aggressive physical distancing and lockdowns.
However, replacing these measures will need something just as immense to stop the spread of the virus. Thus, testing will need to take place on a massive scale if it’s going to replace drastic measures.
Currently, the US doesn’t have sufficient test kits to meet all the needs in the hospitals. And for the country to contain and eventually stop the spread of the virus, the US must actively search for potential spreaders and test them.
Nearly five months since the first confirmed COVID-19 case was reported in the United States, the demand for testing kits still outweighs the supply. Even test makers find it hard to ramp up their testing capacity. Despite President Donald Trump assuring that whoever needs a test will get one, the reality is that very few people have gotten tested, probably because of the shortage of the necessary supplies, especially the testing kits.