Accuracy of Coronavirus Test needs to be Measured

Testing for the coronavirus has been a hot topic across the United States the past few weeks.  The Trump Administration has been accused of not acting fast enough to ensure there were enough test kits and laboratories available to quickly determine whether an individual was infected with this strain of novel coronavirus or not. “Novel” simply means “new”.  This virus had not been previously detected in human beings.   While progress has been made to increase availability of testing and lab results, there still remains reports of sick people being denied the COVID-19 test because they were not sick enough to require hospital resources such IV fluids, oxygen masks, or admittance. 

The word coronavirus refers to a large family of viruses.  “Corona” is from a Latin root meaning crown.  It received this name because, when looked at under a microscope, the virus shape is similar to that of a crown or ring of light.  When the virus first threatened the United States, it was briefly referred to as the Chinese coronavirus because it was first identified in the city of Wuhan, China in late 2019.  Political correctness quickly sounded the alarm and the word Chinese was dropped in favor of the World Health Organization acronym, COVID-19.  Now, if you refer to this virus as the Chinese coronavirus, you will be called a racist. 

COVID-19 stands for coronavirus disease 2019.  The actual name of the virus is SARS-CoV-2.  SARS is an acronym for severe acute respiratory syndrome.  Fortunately, there are laboratory tests that can detect SARS-CoV.  For a laboratory to conduct a test for COVID-19, it must have a test kit.  Whether there are enough kits in a particular state to meet the demand for testing is determined by how many people are chosen for testing.  For example, if testing is only administered to those individuals that require hospitalization, far fewer kits are required than if the goal were to be to test every person with a high fever and a cough.   

There also needs to be enough laboratories to examine the specimens collected.  Assuming there were enough test kits available, if President Trump issued an executive order requiring every citizen to be tested for COVID-19 by April 30, 2020, it would take years for all the CDC certified laboratories across the United States to conduct over 330 million tests and deliver results.  What is lacking, across the nation, are firm markers that trigger the need for testing.  Currently, the guidance from the Centers for Disease Control and Prevention is for people to call their doctors if they believe they have been exposed to COVID-19 and have a fever and other symptoms like a cough or difficulty breathing.  From the CDC web-page titled COVID-19:

If you are a close contact of someone with COVID-19 or you are a resident in a community where there is ongoing spread of COVID-19 and develop symptoms of COVID-19, call your healthcare provider and tell them about your symptoms and your exposure. They will decide whether you need to be tested, but keep in mind that there is no treatment for COVID-19 and people who are mildly ill may be able to isolate and care for themselves at home.

Gearing up for widespread testing appears to be the direction many states are heading.  Across the United States and around the world, laboratories are working hard to create their own tests that produce faster results.  Biotech companies are also aggressively pursuing innovative test kits and testing methodologies that produces results in a few hours versus a few days. 

This emerging private / public partnership to identify COVID-19 is commendable, but not surprising.  When Americans focus and work together to solve a problem, great results can be expected.  However, when private enterprises are eager to meet the cut, so not to miss out on a great opportunity to profit, and the CDC is fast-tracking certifications to laboratories for testing, vulnerabilities in protocol can be missed or ignored.  Fraud is an ugly reality that also cannot be ignored.  With private laboratories across the United States conducting COVID-19 tests, it is impossible for the CDC and other federal agencies to ensure the public that standards are maintained throughout the months to come.  Sadly, and even when lives are on the line, some private labs will produce results without actually testing samples.  Others, driven by profit motive instead of civic duty, will take short cuts which could produce false negative or false positive results. 

What is missing from our pandemic news coverage and public announcements from state and federal officials is the current accuracy rates of the COVID-19 tests.  According to Dr. Roger Seheult MD, “These tests are not as sensitive as you may think”.  Dr. Seheult, an Associate Clinical Professor at the University of California, Riverside School of Medicine and Assistant Clinical Professor at the School of Medicine and Allied Health at Loma Linda University, says that the sensitivity rate of the COVID-19 tests is approximately 70%.  This means there is a 30% chance of a being infected with COVID-19 and getting a negative test result.  Seheult is also a Clinical and Exam Preparation Instructor and co-founder of Medcram.com. 

There are many variables that can corrupt the COVID-19 laboratory test results.  Insufficient or premature sample collection will produce a negative result when the person tested is actually positive.  The pressure on laboratory technicians, both government and privately operated lab technicians, to churn out results will lead to mistakes.  Private companies that are driven by profits over principles will produce results without actually conducting some tests.  Others will succumb to short cuts to speed up testing production, only to discover later that the steps skipped compromised the entire test, rendering the results as inconclusive. 

With a 30% chance of a person having the coronavirus and yet testing negative, every American should follow these recommendations:

·         Clean hands frequently with alcohol-based hand rub or soap and water

·         Cover nose and mouth when coughing and sneezing with tissue or flexed elbow

·         Avoid close contact (3 feet) with anyone with cold or flu-like symptoms

The CDC needs to report testing accuracy rates along with the other COVID-19 data found on its website.  State governments need to spot check their laboratories for consistent quality assurance and make inspection results available to the public.  A 30% false negative test result rate is not acceptable.  Understandably, state governments, along with the federal government, do not want the civilian population questioning the validity of the COVID-19 test results.  However, accuracy rates will not improve unless the people collectively insist on transparency and changes in the entire testing process until false negative results are reduced to 5% or less.