Perspective on COVID-19 Testing

It’s November and Thanksgiving is on the horizon. Patients, friends and family hope to return home, quarantine safely from COVID-19, and then share the holiday in some safe manner with the people they love. They all have their individual plans for traveling home, quarantining and testing themselves for COVID-19 and, in most cases, the plans are well intentioned but unscientific.

After traveling home by plane, if you arrive with no symptoms of COVID-19, it will take about 4-5 days after you arrive home to produce enough viral load for the tests to detect the virus if you have been infected. Testing immediately before you board a flight only tells us if the virus is present before you left – specifically, did you have exposure 4-5 days prior to traveling?

Upon arriving home, rushing out for a “quick test” while you have no symptoms will not answer the question of whether you are a contagious asymptomatic carrier of COVID-19 or not. The “Quick Tests” being used were designed specifically to detect individuals who are sick with symptoms. They were not designed to screen for asymptomatic carriers despite them being used that way locally by walk- in clinics and testing sites. They detect a surface protein on the virus and are far less accurate when used for screening than the traditional PCR nasopharyngeal swab test sent out to the lab.

The incubation period once exposed to the disease should be 14 days or less but some documented cases have lasted a week longer. If you have no symptoms and are tested by PCR nasopharyngeal swab at five days post arrival, and again at 7-10 days, and are negative, you are probably not infected or contagious. That means you probably can see your loved ones at a safe social distance wearing masks and eating and drinking at a distance using separate utensils and plates without infecting each other. An outdoor setting is safer than an indoor venue.

The PCR tests are clearly the most accurate. They require sampling a specimen from high up in your nostrils using a special nasal swab. This is placed in a tube with transfer medium and shipped to a lab. Transferring the material from the tube it arrives in requires a specialized plastic pipette. Think of a pipette as a finely calibrated medicine dropper designed to fit perfectly inside the tube with your specimen and then seamlessly fit into the testing machine and deliver a calibrated sample for testing.

United States labs ran out of these pipettes early in the pandemic and, since they are produced overseas, supply chain shortages developed. With the current administration not instituting the War Powers Act to ramp up production of supplies needed to quell the pandemic, US firms did not tool up to manufacture pipettes or the chemicals required to perform the tests.

In many cases, hospitals and health care systems attempted to purchase the analytic machines required to perform PCR COVID-19 testing at their facility but machines ordered in December 2019 are now just being delivered without reagents 10 months later.

There are few, if any, peer reviewed clinical trials setting a gold standard for testing accuracy. In every case, the FDA issued an emergency use authorization to the product manufacturer of the test based on the data provided by a trained professional in the manufacturer’s lab. Contrast that with the personnel performing the tests at the many public test sites and you see why accuracy is an issue.

 “Quick tests” were designed to distinguish sick people with COVID-19 from sick people with symptoms of an upper respiratory tract infection other than COVID-19. They were not designed to test asymptomatic individuals who may be contagious early in the incubation period of the disease.

The Abbott Bianox test is the most well-known with the Federal government purchasing 150 million tests, making it virtually unavailable to any other health care systems. Tragically, it is being used locally at test sites for screening rather than its intended purpose of diagnosing symptomatic individuals.

I have sent patients with symptoms over to the FAU and Town Center Mall parking lot test sites for testing. Those sites advertised both the PCR test and quick test. When the patients reached the front of the line, they were told that the site was out of the quick tests and so they are still waiting for their results from the lab with the traditional PCR test.

Most were unhappy having to wait so they asked about the quick test I mentioned in a previous blog article with results available in hours. I called their medical director who told me that one of the machines was in repair and with chemical reagent shortages the four to eight-hour turnaround time for results is now 48 hours at best.

There will be new tests developed that are quick and reliable. It will take time. For now, we are left with distancing, wearing masks, practicing repetitive effective hand washing and avoiding crowded public places especially if they are indoors.

Drug Shortages Exacerbated by the COVID-19 Pandemic

Globalization and overseas outsourcing of manufacturing has resulted in periodic drug and medical supply shortages since 2001. This issue has been brought to the attention of US authorities multiple times with no action on the part of several administrations.

On this blog I have written about the defunding of the FDA so that many of the drug producing factories in China and India have not been inspected by FDA inspectors for quality in decades. Within the last five years the only major producer of intravenous fluids for the United States and Canada, located in Puerto Rico, was shut down after hurricane damage and electrical grid damage. The US Military was impacted by this factory shutdown and tried to purchase fluids from overseas producers, but they were at top capacity and could not meet the demand. There have been critical shortages of morphine for pain control.

The pandemic has further exacerbated this issue. CIDRAP, the Center for Infectious Disease Research and Policy at the University of Minnesota reported on its website that there is a shortage of 29 of 40 drugs crucial for treating COVID-19 patients. The shortage includes the short term anesthetic propofol, the bronchodilator albuterol, hydroxychloroquine (used for rheumatoid arthritis and certain lupus patients), fentanyl and morphine. The Food and Drug Administration has its own critical list of shortages and lists 18 of 40 on their drug shortage list. An additional 67 out of 165 critical acute drugs are listed as in short supply. This list includes acetaminophen (Tylenol), lidocaine, diazepam (valium) and phenobarbital among the most noteworthy.

As the election for President concludes, it is far overdue for whomever prevails to dedicate one department to evaluate, plan for and prevent critical drug and supply shortages. It is also long past due that the production and distribution of these key pharmaceuticals and medical supplies return to the United States so we are not subject to the whims of a foreign government or find ourselves trying to outbid our allies for supplies.

Michael Osterholm, MD, the director of CIDRAP, sees the coming increase of COVID-19 cases further challenging the existing supply of medications available to the American public.