Challenges Currently Faced by the COVID-19 Tests and Assay Kits

6 mins read

COVID-19 test kits are facing undeniable problems as the number of cases soared day by day. Leaders from different countries wanted to perform mass testing for their people with the hope of containing the infection. Unfortunately, test kits are not yet made available to everyone. Persons who get tested with these kits are those who are under investigation.

There are lots of questions circulating this issue. Lots of people are asking, where are those testing kits? Are there enough test kits for all the people under investigation? Or Are there enough for everyone?

Below are the problems these test kits are facing. By understanding these problems, maybe you can answer those questions you have in mind.


The demand for the COVID-19 IgG/IgM Immunodetection Kits went up. Though pharmaceutical companies continued to supply these kits, the demand was never met. The number of persons who need testing is double or even triple the amount of the available test kits.

One of the apparent reasons for the shortage of these testing kits is the pandemic itself. Manufacturers could not cope up with the demand because the virus spread rapidly. Developing these kits is not as easy. It is very intricate and needs careful assembling. The second reason for the shortage is the high demands for the chemical reagents, which used to create these test kits.

But on the bright side, other companies are starting to produce alternative COVID-19 test kits to help meet today’s demands of test kits. Soon, there will be test kits available for everyone, whether you are a person under investigation or just a walk-in patient who wants to get tested for COVID-19.


Aside from the shortage of the chemical reagents needed to create testing kits, staffing shortages, and lack of instrument access also slow down the production of the testing kits. As the demand goes up, staffing needs also increase.

Manufacturing testing kits for coronavirus should be done with care and precision. These kits must produce an accurate result, or it would be useless. Millions are invested in these test kits, and a false result may put the manufacturer in jeopardy.

As the demand goes up, staffing needs also go up. All testing kits existed in the market today, whether it is for COVID-19 or other viruses and bacterias, all of them went through a lot of processes before it became enough for everyone.

The Deployment of the Test Kits

Deploying the kits is also very difficult to do. First, you have to map the population. You will be looking for people who developed immunity to the virus. Antibody test kits are only useful after a person acquired the virus. It is why antibody test kits are not suitable for early detection of the infection.

PCR tests are not encouraged to do at home since it is complicated to administer. You will need a well-trained professional and some equipment to do the PCR testing. As of now, PCR Testing is the only way to detect the presence of the coronavirus in real-time.

Deployment of these test kits is limited, and the production in a specific area depends on the data. This data is based on the number of confirmed cases and persons under investigation of that particular area. Given that the test kits faced shortage problems, manufacturers could not deploy as many test kits as they wanted.

Authorization and Accuracy Issue

Many companies have already produced testing kits, but the FDA only approves a few of them. As of today, there are 59 molecular tests and four serological tests that are authorized by the FDA. Another 100 testing kits are still waiting to be approved by the agency.

The accuracy has a lot to do with the authorization of the product by the FDA. These kits should undergo an accuracy test to be eligible for FDA authorization. There have been issues circulating that test kits from China are unreliable. This is what the FDA wanted to avoid; that’s why they are very strict about the product authorization.

There are many false-negative results documented around the globe. This false result only puts the patient in danger because physicians won’t be able to administer the proper medication for coronavirus if the test is negative.

Manufacturers and the FDA couldn’t determine how common this false negative happens. But they are gathering all the data regarding this accuracy issue and hoping that it would be solved soon.


COVID-19 test kits demand skyrocketed and expected to rise in the upcoming days. While everyone is waiting for the coronavirus vaccine, people are hopeful that these test kits will provide a temporary solution to the pandemic. Many people are requesting to be tested but denied because they are not the ones who should be prioritized. Testing kits are reserved for people who have severe COVID-19 symptoms. Hopefully, this situation will be eradicated soon.

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