Following the outbreak of COVID-19, a call for robust testing spurred innovative solutions. These included processes for tracking COVID-19 cases, commercially available rapid at-home tests and methods for sending self-collected specimens to testing laboratories.
More than 2 years after the COVID-19 pandemic began, researchers and diagnosticians are examining the following questions to improve public health: How can we expand the collection of specimens in non-clinical spaces for testing that will subsequently occur in laboratories? How can access to health care be improved through self-testing and the self-collection of specimens?
COVID-19 Ignites a Trend of At-home Specimen Collection
The self-collection of specimens for COVID-19 testing helps reduce exposure to SARS-CoV-2 and allows for a higher testing frequency when appointments and capacity in clinical spaces are limited. Dr. Susan Harrington, Director of Microbiology Processing for Cleveland Clinic, said at-home sample collection-in this case, the process of collecting a nasal swab or saliva sample and sending the sample to a clinical laboratory for further polymerase chain reaction (PCR) testing-is a growing trend in health care that could dramatically shift how we test for viral infections.
"At-home specimen collection was put to use during a COVID-19 surge, either because we didn't have enough swabbing appointments, or because we didn't have enough personnel," Harrington said. "Being able to collect a saliva sample or a nasal swab is also compatible with telemedicine. We're certainly seeing more requests from our physicians who are interested in telemedicine approaches. It can help reach patients who do not live near a testing site as well as patients who can't leave the home."
In June 2020, a study conducted by the University of Washington and UnitedHealth Group demonstrated that the self-collection of specimens for COVID-19 PCR testing produced results similar in accuracy to that of PCR testing where specimens were collected by health care professionals in clinical spaces. The authors also noted how self-collection testing can help testing sites reduce the amount of personal protective equipment (PPE) required for staff and allow for a "more comfortable patient experience." Another study, published in September 2020, examined the willingness of individuals to provide self-collected specimens for COVID-19 testing. Of the more than 1,400 respondents, almost 90% said they would be willing to collect saliva samples or throat swab samples at home for further testing, with significantly fewer participants expressing willingness to provide these types of samples in clinical settings. Researchers also inquired about the overall experience of self-collecting specimens for COVID-19 testing. A March 2022 study surveyed more than 1,000 participants in Atlanta and found most participants cited a positive experience during self-collection, with more than 79% of participants noting "ease and comfort."
At Cleveland Clinic, self-collection practices have been especially helpful for testing patients for COVID-19 who may be entering the health system's facilities for a procedure, or for patients who may need to stay the night at a facility. Additionally, Harrington noted self-collection can reduce risk for patients who are immunocompromised and may face additional exposures by entering a clinical space. During COVID-19 surges, when thousands of health care workers stayed home after exhibiting symptoms of the novel coronavirus, self-collection also helped reduce potential exposures in clinical settings.
Self-Collection for Sexually Transmitted Infection (STI) Testing
There is more interest than ever in at-home testing for other types of infections, including STIs. Prior to the outbreak of COVID-19, chlamydia (caused by the bacterium Chlamydia trachomatis) was the most commonly notifiable infectious disease in the U.S. (since 1995 when it earned the identifier of 'notifiable disease'). Chlamydia, now second only to COVID-19, was followed by gonorrhea (caused by Neisseria gonorrhoeae) and syphilis (caused by Treponema pallidum), respectively. "STIs occur on a frequency that's orders of magnitude higher than many other infectious diseases, so we really do need to do something to better improve our control efforts," said Dr. Barbara Van der Pol, president of the International Society for Sexually Transmitted Diseases Research and professor of medicine and public health at the University of Alabama at Birmingham.
For patients with Medicaid, assigned female at birth and under the age of 25, for example, the percentage of individuals tested annually for STIs rarely breaks 60%. For individuals within the same demographic who have private insurance, it's closer to 50%. "Think about all the people out there that should be screened annually that aren't accessing the service, or the service is not being offered to them if they do go into a clinical space," Van der Pol said. At-home testing is a compelling option to help increase the frequency of annual STI testing. Due to the nature of some STI tests being invasive, and the stigma surrounding this type of medical testing, Van der Pol said self-collection could help empower individuals to take charge of their health care in a way that is most comfortable and accessible to them.
Building a Self-collection Process
At Cleveland Clinic, self-collection kits are put together by a third-party vendor, and then they are distributed through local warehouses. COVID-19 kits typically include a set of instructions, a flocked nasal swab, a 3 mL tube of saline solution, a biohazard bag and a padded envelope. Once self-collection is complete, kits can be dropped off at collection bins, which the health system has outside of their pharmacies and express care locations. These bins are swept by couriers at least once a day, and the health system's molecular testing lab conducts tests within 24 hours of sample pick-up. In a talk at ASM Microbe in June 2022, Harrington recommended considering the following questions when developing self-collection kits of all kinds, not just for COVID-19 tests:
How will the kit be produced and assembled?
How will the kit be stored (e.g., is there a specific temperature at which specimens must be kept)?
How will kits be obtained (e.g., will the kit be offered directly to consumers, or will the kit only be provided with a physician's order)?
How will specimens be collected by the individual at home?
How will specimens be returned to the clinical laboratory (e.g., via mail, via drop-off site)?
How will the results of the test be provided?
Harrington emphasized the importance of including easy-to-follow directions for each self-collection kit. For example, Cleveland Clinic patients have access to information via the health system's website, instructional videos and FAQs, in addition to written instructions that are included directly in the kit.
When it comes to at-home testing kits for STIs, how samples are collected is key. Van der Pol recommends collecting samples via swabs rather than urine. According to a 2017 survey of public health laboratories, while vaginal swabs are more effective for detecting infections, most testing practices call for urine samples. In clinical office settings, residual clean catch midstream urine is often recommended for people asigned female at birth, as it prevents bacteria from around the urethra from contaminating the sample. However, Van der Pol explained that "residual clean catch midstream urine can be missing almost 20% of infections. This is a real disservice." First-catch urine samples for people assigned male at birth and swab samples for people assigned female at birth are more likely to produce accurate results.
Therefore, for at-home sample collection, swab testing makes sense, both in terms of practicality, and efficacy. "When you think about collection at home, individuals are going to swab because it's a dry sample they can send in, and it's an easier sample to get," she said. Emphasizing the importance of considering data to develop evidence-based testing models with high efficacy, Van der Pol said swab samples are appropriate for people of all genders conducting at-home specimen collection.
Lessons Learned from COVID-19
With the need for expeditious test results throughout the COVID-19 pandemic, patient expectations regarding diagnostics have shifted. As a result of the pandemic, there is more infrastructure in place to develop at-home self-collection and testing materials for infections other than COVID-19. "This is our silver lining from the COVID-19 pandemic," Van der Pol said. "People have learned how to do over-the-counter testing, we have the technologies and people have actually invested a fair amount of money to make the reporting process to local health department jurisdictions work. So there are solutions out there that we can now apply." Moving forward, researchers and diagnosticians will continue to investigate how to best develop and deploy at-home self-collection and testing equipment in order to ensure equitable access for all.
"We need a new equity-conscious paradigm that really thinks to all the issues that stop people from getting these services," Van der Pol said. "Labs need to be aware of the issues surrounding this topic, including the sample efficacy issues that are really critical. Home collection management and home testing are here to stay, and we need to get on board and figure out how to implement these practices."
Research in this article was presented at ASM Microbe, the annual meeting of the American Society for Microbiology, held June 9-13, 2022, in Washington, D.C.
Continue learning about this important topic with ASM's new Clinical Public Health webinar series: The Growing Opportunity of Self-Collection and Self Testing in Clinical Microbiology. This 3-part series explores the current state of self-collection tests for respiratory viruses and sexually transmitted infections. Get up to date on the latest on Sept. 21, 2022 while earning up to 3 continuing education credits.
