Chemical shortages delaying COVID-19 testing results

Introduction

Being able to quickly and accurately identify individuals with COVID-19 has been one of the most effective methods in preventing the spread of the disease. This allows infected people to be appropriately isolated from the rest of the public and prevent others from contracting the infection.

As COVID-19 remains prevalent, more and more people continue to get tested in order to try to stay ahead of the curve and properly manage themselves in a health sense. In fact, the World Health Organization (WHO) has urged countries to ramp up testing for COVID-19. However, with testing numbers continuing to rise, significant stress and demand is placed on companies that make and supply COVID-19 tests.

One demand that has substantially increased over the past months are the chemicals needing to perform the tests. Specifically, the supply of critical components that help identify the SARS-CoV-2 virus, which is the Coronavirus specifically responsible for COVID-19, have been in shortage due to the drastic increase in demand of tests.

  • What effect does this have for people getting or wanting to get tested?
  • What is being done to help increase the supply of the certain testing components?

The purpose of this article is to inform about the chemical shortages currently effecting COVID-19 testing and what is being done to resolve the issue.

What chemicals are facing a serious shortage?

Chemicals are a critical component of testing, one of these being reagents. Essentially, reagents are the main ingredient of any chemical based test and includes inorganic solutions, enzymes, probes, and primers created to match a specific organism’s genome; in this case the organism is the SARS-CoV-2 virus.

The COVID-19 crisis has exploited testing company’s vulnerability to these chemical shortages due to sudden demand, export bans, and stockpiling.

Extremely specialized reagents

These reagents are extremely specialized requiring that certain approved entities have to make them. The most widely used COVID-19 tests currently are viral tests, or commonly called RT-PCR’s, which uses a “primer” reagent. This reagent targets specific sections of the virus’s genome in order to Identify if the SARS-CoV-2 virus’s RNA, the genetic code, is present in an individual.

But a primer is not the only chemical involved in testing.

  • A certain chemical is needed to extract the virus
  • Another chemical is needed to amplify the virus
  • Yet another chemical is needed to detect the virus (the primer)

The COVID-19 crisis has exploited testing company’s vulnerability to these chemical shortages due to sudden demand, export bans, and stockpiling. The scarcity of the specific chemicals involved in testing is also a result of limited production capacity and a market dominated by just a few lab companies.

No one was prepared for a new pandemic to be on the horizon and since all the major countries in the world are wanting the same identifying chemicals at the same time, it has created a shortage of needed supplies.

So, what does this reagent shortage mean?

The abrupt notion to drastically increase the testing of individuals for COVID-19 has caused a shortage in needed materials to perform the test. This has resulted in a major delay in people getting tested and obtaining the results of tests in a timely manner.

Overall, the shortage of chemical testing components prevents individuals from necessary care plans and increases the risk of continuously spreading the disease.

Test result times can stretch out for weeks

Actually, results initially would have been reported back to the test participant in 1-3 days. Now, test results may take up to 2 weeks or longer due to the shortages. This essentially puts the individual at an increased risk for inappropriate measures of care, which in turn puts others at risk of contracting the virus. It has also discouraged many people from getting tested at all because of the possible two-week wait to obtain results, and then another length of time for self-quarantining (if one does end up testing positive).

Ironically enough, if it does take two weeks to hear the results the person has a good chance of not even having the disease anymore. Overall, the shortage of chemical testing components prevents individuals from necessary care plans and increases the risk of continuously spreading the disease.

What is being done?

Private lab companies continue to ramp up production in order to meet the recent demand in COVID-19 testing. Businesses are striving to maximize existing laboratory and employee copacity in order to boost testing production rates.

Another measure being taken to bridge the gap between supply and demand is healthcare providers carefully selecting which individuals to test. It is important to not waste testing supplies on individuals who are at low risk of being infected with the virus, while saving testing materials for patients who are at moderate to high risk. This will help the testing process be more relevant, effective, and efficient.

Lastly, but certainly not least, are the actions taken by the U.S. Food and Drug Administration (FDA). The FDA recently issued the Emergency Use Authorization (EUA) which may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose. Under this new guidance, laboratories certified to perform high complexity testing under CLIA were allowed to use their own COVID-19 lab developed tests after validating them but before receiving FDA authorization.

Under new guidance, laboratories certified to perform high complexity testing under CLIA were allowed to use their own COVID-19 lab developed tests after validating them but before receiving FDA authorization.

What else is being done you ask?

Also, on June 12, 2020 the FDA granted an amendment to the EUA for the CDC diagnostic test to address global shortages of materials needed to perform the test. This particular amendment provides alternatives for processing the test and includes the following:

  • Four additional extraction reagents can now be used with the existing extraction methods.
  • An additional extraction instrument and associated reagents have been developed.
  • A new process that can be used in place of the extraction method when materials for the current method are limited has been approved.

As one can see, many steps are being taken in order to maximize COVID-19 testing in the United States and provide individuals with timely results. But as the disease continues to be prevalent, indication for amplified testing will constantly be warranted, which in turn may maintain or even widen the gap between supply and demand.