The COVID-19 pandemic is accelerating changes already underway in the practice of medicine, spurring both innovations and growing pains around technologies that allow patients to interact with the healthcare system virtually.
An April survey conducted by Sermo, a physician online community, reported that 85% of participants are seeing patients via video and phone. The survey also found that 68% of respondents believe this will have a lasting effect on how doctors see patients, and 77% support the shift to telemedicine. The telemedicine market is expected to be a $155 billion industry by 2027, according to Grand View Research.
This drive to see patients at home has also increased interest in at-home sample collection and testing, both for convenience and to avoid potential exposure to SARS-CoV-2, the virus that causes COVID-19 illness. “COVID-19 has accelerated this,” said Arielle Trzcinski, a senior analyst at Forrester, a market research company. She anticipates “a greater push on how we get to more convenient, cost-effective options for lab testing. Some vendors are already working on that, but it’s still an area that is further ripe for disruption and innovation.”
Pandemic Concerns Speed Up Market for Home Testing
As the pandemic bore down on the healthcare system and the economy, companies began moving to bring direct-to-consumer (DTC) testing services online. Now, more steps of the testing process are entering patients’ homes, from test ordering to sample collection. Patients themselves might even perform certain tests.
On April 21, the Food and Drug Administration (FDA) authorized LabCorp’s Pixel for COVID-19, the first at-home sample kit for SARS-CoV-2 testing, specifically for LabCorp’s COVID-19 reverse transcriptase polymerase chain reaction test. The self-collection kit contains nasal swabs, saline, and an insulated package for sending the samples back to LabCorp.
Of course at-home testing isn’t new, especially when it comes to collecting cheek swabs and saliva. Consumers already have enthusiastically embraced kits marketed for allergies, vitamin D, food sensitivity, and DNA testing—for humans and pets. But most of these tests report genetic traits or conditions that “are not going to necessarily indicate a life or death situation,” said Trzcinski.
Telemedicine startups Vault Health and hims & hers, and DTC genetic testing company Vitagene, are now all selling home-collected saliva-based test kits. The actual testing for all three companies is performed by Rutgers University laboratory, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs. FDA authorized the RUCDR test on May 7, and prices range from $116–$150.
Scanwell Health, a developer of smartphone-enabled, at-home diagnostics, has announced its work on a test kit ordered from and conducted at home. Scanwell has exclusive rights to license and distribute a SARS-CoV-2 rapid serology test from Chinese company Innovita. The test takes 15 minutes to complete using the Scanwell Health mobile app, and under the company’s plan, a doctor or nurse practitioner would reach out within hours to a patient with results and next steps. Scanwell is known for developing the first urinary tract infection test cleared by FDA for home use.
Most recently, DTC company LetsGetChecked received FDA authorization for its Sure-track test that includes at-home nasal swab sample collection and lab-based molecular testing for SARS-CoV-2. The company touts that it is the only DTC offering with an FDA emergency use authorization for at-home COVID-19 testing that owns all aspects of the testing service, including the collection kit manufacturing process, logistics, lab analysis, and physician approval.
Demand has also spiked for SARS-CoV-2 antibody and antigen tests that are easier to accomplish with small blood samples compared to the nasopharyngeal and nasal swabs used for lab-based molecular diagnostic assays.
In late April, Quest Diagnostics announced it would start selling a COVID-19 antibody test directly to consumers for $119. This test still requires a blood draw at one of the company’s patient service centers, and the utility of antibody tests remains unclear. This caveat hasn’t stopped consumers from purchasing the test (Quest said it had performed 975,000 antibody tests as of May 18), reflecting demand for ways to take blood samples without risking COVID-19 exposure and for a testing process anchored to consumer convenience.
Advances in Sample Collection Arrive at an Opportune Moment
Innovations in blood sample collection are proving their utility and validity just in time for the home-based medicine push. One such system is Neoteryx’s Mitra devices, which collect 20 μL of blood from a finger prick. Cathy Cordova, Neoteryx’s director of marketing, said Mitra is already used by organ donor transplant recipients, who need frequent blood tests to check their immunosuppression. Home testing lets them avoid coming into a healthcare setting repeatedly for blood draws, and makes frequent testing easier for those who live in rural areas, far from hospitals and clinics.
A study recently published in The Journal of Applied Laboratory Medicine found that 82% of patients preferred using this microsampling device for therapeutic monitoring of tacrolimus and cyclosporine immunosuppressants following solid organ transplants (J Appl Lab Med;2020;5:516-30).
Neoteryx has also worked with “several large pharmaceutical companies that have looked to implement their phase I, II, and III clinical trials for drug development through what they’re calling virtual clinical trials,” Cordova said. These patients can participate while taking their own blood samples from home.
Mitra will also be used for a National Institutes of Health (NIH) COVID-19 serosurvey, a nationwide COVID-19 antibody survey that researchers hope will help determine how many adults without a confirmed history of COVID-19 virus infection already have antibodies. NIH plans to test as many as 10,000 volunteers, who will be shipped Mitra kits to take their own blood samples at home.
“Unfortunately, I think it’s taken the pandemic to really put a spotlight on the value of remote sampling,” Cordova said.
Researchers also are showing that with the right technique and instruments, an old technology—dried blood spots—can be updated to offer lab-quality results for many analytes. According to authors of a paper published in Clinical Chemistry, “broader adoption of these specimen types should provide opportunities for more efficient individualized health monitoring with an overall objective of improved health and wellness” (Clin Chem 2020;6:821-31).
Potential Hurdles for Clinical Laboratories
For clinical laboratories, the ramp-up of at-home testing isn’t necessarily straightforward, and the experience of those who’ve worked with some of the new technologies suggests labs will face speed bumps along the way. The first is ensuring that a sample is taken correctly. “You need really clear instructions on how to do the test properly,” Trzcinski said. For example, over- or under-saturating microsamplers with blood could ruin the test. Second, users of these tests also need information on how to interpret their results. Telemedicine is being deployed to solve both these issues.
For COVID-19 testing, AACC has asked FDA to ensure robust scientific evidence and transparency around home sample collection. Unique preanalytical problems often surface with self-collection methods that can put patients at risk, the association emphasized in a letter to the agency.
“While home sample collection kits are designed to be simple, problems commonly occur with self-collection that can affect the quality of the sample and, therefore, the subsequent test result,” the letter said. Moreover, in the case of LabCorp’s Pixel test system, the experiments the company conducted showed stability of live virus that had been spiked onto swabs. “But no experiments were publicly shared that demonstrate equivalence between specimens collected by healthcare professionals and specimens collected by the patients themselves at home,” said AACC’s letter. LabCorp declined to comment for this story.
Laboratories themselves likely will face mounting challenges when asked to process samples taken from home kits. Last year, Kamisha Johnson-Davis, PhD, DABCC, FAACC, associate professor of pathology at the University of Utah and medical director for clinical toxicology at ARUP Laboratories in Salt Lake City, ran a feasibility study on the Mitra device. The research team specifically looked at using the device for immunosuppressant drug monitoring (J Appl Lab Med 2019;4:241-6).
Johnson-Davis raised several issues about the device, including the potential to over- or under-saturate the Mitra tip. Her laboratory team also had to figure out how to fit the Mitra device into their workflow so that it could be tracked just like any other sample. The shape of the Mitra device also posed a complication, she said: The one they tested is clamshell-shaped, “which is totally different from the collection tubes that we use.”
Johnson-Davis also had concerns about the quality of the samples themselves. “As a medical director interested in these alternative ways of collecting specimens, it would be of interest to understand how this would work in practice in someone’s home,” she said. Laboratory directors would need to know how they can be sure of the sterility of the sample-taking environment, if patients are milking their fingers, and what happens to a sample between the time it’s taken and when it shows up at a laboratory.
“In practice, we just don’t know how patients are really going to transport samples,” said Johnson-Davis. “Let’s say it’s summertime and they forget they had it in their car but put it in the mail anyway. What’s going to happen to that specimen?”
Transportation logistics extend to laboratories too, she said. Maybe a laboratory doesn’t receive mail on Saturdays. Or a patient puts a sample in a mailbox on a Saturday afternoon but it isn’t picked up until Monday.
“There are things we would need to work out in regard to specimen processing on-site and having it accommodate our track system,” she added. Plus, “we would need communication and videos on appropriate specimen collection and transport for the clients who would potentially be using these.”
In all of these remote sampling scenarios, clinical laboratory professionals have an opportunity to lead—from discovering how technologies and techniques work in the real world to developing the right quality systems that ensure high-quality results for patients, regardless of where sample collection takes place.
Jen A. Miller is a freelance journalist who lives in Audubon, New Jersey. @byJenAMiller