By Melissa Laitner, PhD, MPH, SWHR Director of Science Policy
In the face of the novel coronavirus pandemic, COVID-19 testing is a crucial element in the fight to end disease spread. Without improved screening and diagnostic rates for coronavirus, we lack a clear picture of how the disease is spreading, hindering society’s ability to ease back into normal operations.
Why Testing Matters for Women
Testing is particularly important to identify asymptomatic carriers of SARS-CoV-2, the coronavirus that causes COVID-19. A recent study in the New England Journal of Medicine suggested that among 33 pregnant women who tested positive for the virus, 29 were asymptomatic when the test was administered. According to an estimate from Dr. Robert Redfield, director of the Centers for Disease Control and Prevention, 25% of people infected with coronavirus may not show symptoms and therefore could unknowingly transmit the disease to others.
Testing may be of particular relevance for women, who tend to fill roles that increase their risk of exposure to coronavirus. Women make up the large majority of health care workers, including over 85% of nurses in the U.S. These groups are likely to have very high levels of exposure to coronavirus and other infectious diseases. So, despite the fact that women are less likely to die from COVID-19, they are still at very high risk for transmitting the virus.
Women are also more likely to be primary caregivers for children and adult relatives, and more frequently tasked with caring for sick family members. Caregivers are more often in contact with sick or vulnerable individuals, putting them at risk of catching or spreading the virus. Therefore, it is important for women to be able to access testing and to understand the different types of tests currently on the market.
Diagnostics and Antibody Tests
The most common type of coronavirus test is a polymerase chain reaction (PCR) test, which starts with a swab to draw mucus from the nasal cavity. The swab is sent to an approved high complexity lab, where viral markers can be extracted and examined. Experts say this type of test is both sensitive and selective, which means it is able to correctly identify almost all positive cases and results in a low number of false positives.
While this type of traditional testing for coronavirus can be performed at very high volume and with high accuracy, results often move slowly. Samples must be shipped to a lab and then the diagnostics take four hours to prepare and test. Getting a result can take two to four days or more, meaning carriers could continue to spread the disease to others if they do not self-isolate until they receive an official diagnosis.
In an attempt to address problems of testing speed, the U.S. Food and Drug Administration (FDA) is granting emergency approvals to developers of faster-acting diagnostics. Some of these rapid tests can provide results in less than an hour, and a few even boast results in less than 15 minutes. Other options are also being considered, including the use of genome-editing technology to create new types of diagnostics. The first self-administered coronavirus test was also recently approved by the FDA, which opens the door to at-home testing.
In addition to diagnostic tests to identify active cases of COVID-19 disease, there is a need for antibody tests that can identify signs of a previous SARS-CoV-2 infection. Antibody testing may ultimately allow us to better understand the true population rate of infection as well as a more accurate fatality rate.
Additionally, scientists hypothesize that individuals with antibodies to the virus in their blood may have some immunity from the virus over the short term, but that this protection will likely decline after about a year. However, the World Health Organization (WHO) has stated, “There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection.”
Concerns With Accuracy
In spite of impressive rates of research and development in response to COVID-19, there have been issues with availability and reliability of both rapid diagnostic tests as well as antibody tests. For rapid diagnostic testing, there is not yet clear data on the frequency of false positives or false negatives.
And many of the new antibody tests are of “dubious quality,” per Scott Becker, executive director of the Association of Public Health Laboratories. In some cases, there are questions as to whether some tests are yielding false-positives because they are cross-reacting with antibodies for other coronaviruses. The FDA recently strengthened standards for approval of antibody tests due to these reported concerns. Starting in May, manufacturers of antibody tests must prove their tests meet minimum quality standards in order to stay on the market.
What does this mean for women? Given how difficult it can be to discern reliable tests from less reliable ones, decisions on testing in any form should take place following a discussion with your physician. Some areas are struggling to access tests, so patients may be prioritized for testing depending on risk factors and intensity of symptoms. A physician can also tell you whether you should self-isolate in response to symptoms and may be able to answer questions about caregiving and disease transmission.
The Future of Coronavirus Testing
More research into rapid diagnostics and antibody testing will be important in minimizing severity of impact and spread of the disease. For example, antibody testing with valid and reliable technology could be helpful for the many women employed in health care: If workers are found to be immune, they can be assigned to patient care with less concern that they will contract the disease. Similarly, for women providing caregiving to loved ones, better understanding of immunity will help to decrease the likelihood of passing the disease to high-risk friends and family members.
We are likely still weeks away from true widespread testing, however. Labs are experiencing unprecedented levels of demand, and lack of federal leadership regarding a national testing strategy means that testing has remained inconsistent across much of the country. Reimbursement issues have also been noted — per Julie Khani, president of the American Clinical Laboratory Association, “labs have been asked to do more with less.”
Ultimately, federal focus on strategic testing will be crucial to stopping disease spread. The Trump administration announced on April 27 a plan to increase capacity for coronavirus tests nationwide. The president also recently signed a new relief bill, which gives Health and Human Services Secretary Alex Azar 30 days to report to Congress on the details of the administration’s strategic testing plan.
A recent STAT opinion article suggests that our focus must be on gathering comprehensive data from all patients tested (whether they test positive or not), random sampling within communities, financial support for local and community-based testing, and better analyses of existing data. The goal must be to identify not just the worst cases, but mild and asymptomatic cases as well. This type of strategy is necessary to curb disease spread and protect our health — including the health of women, who are more likely to be on the front lines of the pandemic.