Testing for novel coronavirus is still a serious issue in the U.S. due to a lack of lab capacity, test reagents, nasal swabs, and even personal protective equipment for health care workers. Due to these shortages, the CDC is recommending that COVID-19 testing should not be performed on patients without symptoms and instead be prioritized for: 1. hospitalized patients and symptomatic health care workers, 2. patients at highest risk for poor outcomes and symptomatic first responders, and 3. communities with rapidly increasing cases. While the number of diagnosed cases has been steadily rising in the U.S., the true number is likely to balloon once we can test people at scale and get an accurate picture of how many Americans are or were previously infected.
Public health authorities are slowly increasing their testing capacity, and now private companies are coming to the rescue with a range of new diagnostics designed for both the medical setting and at home. The U.S. Food and Drug Administration (FDA) has streamlined its regulatory process for evaluating these new options so they can be available on an expedited basis. Examples include:
- Implementing an Emergency Use Authorization (EUA) process that allows new tests to be approved in a matter of weeks (versus the normal months-long 510(k) or de novo process).
- Allowing rapid serology blood tests to be used in medical settings without prior FDA review, provided certain disclosures are made to patients.
- Enabling self-collection of samples (via nasal swab) under medical supervision at collection sites; this is especially beneficial in hard-hit areas like Washington and New York, where a shortage of personal protective equipment prevents medical staff from collecting specimens safely.
As practicing physicians on the front lines of fighting this pandemic, we applaud the FDA for the extraordinary steps they have taken.
There are two types of tests currently being used: molecular tests (e.g., RT-PCR) and serology tests. Molecular tests look for active infection by detecting the viral RNA in a patient’s sample, like in mucus from a nasal swab. Serology tests look for antibodies formed by a patient’s immune system to the virus. Specific antibodies may be detectable early, and there is evidence that this occurs in the first week of feeling ill from COVID-19. Serology tests are especially useful to determine if someone was infected in the past and has recovered. This can have broad implications, especially for health care workers. While more research is needed, knowing an individual has antibodies to the novel coronavirus can help determine when and where the person should work. On the other hand, someone without any natural immunity may be assigned to lower-risk environments.
Here’s what people in the U.S. should expect over the upcoming months in terms of testing:
New molecular testing options should help ease the difficulty of getting tested. The steps taken by the FDA mean that new molecular testing options are available to hospitals and other facilities beginning this week. These new options should at least double testing capacity by March 30th in the hardest-hit areas, and help ease nationwide test shortages thereafter.
Testing frontline physicians, nurses, and other hospital staff will rise in priority. Losing health care workers to illness impedes our ability to help others. We must make this a priority.
At-home testing options will likely be available in May. Last week, several companies announced services for at-home testing. While the FDA recently clarified that at-home testing (including sample collection) still requires regulatory review, the expedited EUA process means this could happen in a matter of weeks. Some of these at-home testing services utilize devices that have already been used successfully to test millions of people in other countries.
Telehealth is essential right now. Telehealth can be used for many health issues that would normally be handled at your doctor’s office, urgent care, or even the emergency room. Most medical offices are encouraging telehealth visits over in-person visits whenever possible. This is to preserve resources at brick-and-mortar facilities and prevent patients from transmitting the novel coronavirus or becoming infected while sitting in a waiting room.
The goal should be that anyone who wants to receive testing for novel coronavirus has access to testing. Universal testing will be an important tool in fighting the spread of this disease and truly understanding its prevalence – and we are likely just a few months away from this happening. Until then, the most effective means of slowing the spread of this disease are to stay home, social distancing, and good hand hygiene.
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