At-home diagnostic testing is a growing field. Home diagnostics allow hospitals and clinics to offer a complete telehealth cycle, reach marginalized patients, and bill more health codes to insurance. Digital health companies can use at-home testing to pair with and support products. As with any growing space, there is some confusion over the finer points of home diagnostics. Is it certified by the FDA? Is it possible to self-collect blood samples without a phlebotomist? What is the difference between at-home tests and point-of-care tests? Whether you’re a physician, a member of a digital health organization, or a potential end-user, here are five things you should know about at-home diagnostic testing.
At-home diagnostic testing is certified by CMS and CLIA, not only the FDA
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Emma Rayner Emma Rayer is the Co-Founder and Head of Strategic Partnerships for Ash Wellness, a remote diagnostics solution that supports traditional healthcare systems, universities, public health initiatives, and digital health companies. As a South African, Emma saw firsthand the devastating effects of HIV and AIDS in local communities. In her first year at Ash […]
There are two organizations that play a complementary role in ensuring regulatory compliance in laboratory diagnostics and the development of at-home diagnostics. The Food and Drug Administration (FDA) regulates manufacturers and devices under the Federal Food, Drug, and Cosmetic Act (FFDCA) to ensure that devices, including those intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, are reasonably safe and effective.
The Centers for Medicare & Medicaid Services (CMS) and its Clinical Laboratory Improvement Amendments (CLIA) program regulates the laboratories themselves to ensure accurate and reliable test results when they perform testing on patient specimens. CLIA also certifies analytical validity. The analytical validation under CLIA looks at the performance characteristics of a test used to describe the quality of patient test results, and includes an analysis of accuracy, precision, analytical sensitivity, analytical specificity, reportable range, reference interval, and any other performance characteristics required for the test system in the laboratory that intends to use it.
Under the CLIA regulations, when a laboratory uses a test system that has not received FDA clearance or approval (such as a laboratory developed at-home diagnostic), the laboratory may not release any test results prior to establishing certain performance characteristics as certified by CLIA’s analytical validity standard.
Businesses can use modern systems to secure health data, not just HIPAA compliance
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
HIPAA is not the only tool to keep healthcare data secure. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal law that supports “national standards to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge.” HIPAA covers health providers, health plans, healthcare clearinghouses, and associates. However, businesses can use more modern technology to protect health data, not just HIPAA. In fact, businesses only need to be HIPAA compliant if they take insurance. Some companies hire in-house engineers to build secure data transfer systems and portals. It’s important to establish security protocols before asking customers to submit sensitive healthcare data.
Comprehensive at-home STI results require three-site testing
Digital health companies, healthcare clinics, hospitals, and public health initiatives have started to offer at-home health testing to combat the meteoric rise in STIs. HIV, hepatitis, and syphilis require a blood test, but chlamydia, gonorrhea, and trichomoniasis use swabs. While many businesses only offer single site panels to test for STIs in the penis or vagina, these aren’t always reflective of how individuals have sex, especially LGBTQ+ people. In order to accurately determine an individual’s real STI status, healthcare organizations and digital health companies must offer three-site testing and provide swabs for the mouth and anus in addition to penis or vagina. Patients and customers should be aware of the limitations of single-site STI testing when working with a provider or digital health company.
It is possible to perform a reliable blood test at home
Home diagnostics providers can use Dried Blood Spot (DBS) cards to test and transport small quantities of blood to labs. Users prick blood from a fingertip and blot it onto the card, where filter paper absorbs the sample. Blood dries in a fibrous matrix, and is shipped in an envelope to a lab for testing. DBS card testing is slightly less sensitive for certain markers due to reduced sample quantity, but peer-reviewed studies report success in detecting diseases like HIV, Hep B and C, or Covid-19 antibodies. DBS cards can test for cancers, allergies, infectious diseases, fertility markers, comprehensive metabolic panels, STIs, and more. This type of at-home health testing is particularly useful for public health initiatives because street teams can transport sample blood without a stabilizer.
Mail-in diagnostics are different than point-of-care tests
There is some confusion about the difference between at-home diagnostic tests and point-of-care tests. Users take point-of-care tests outside a clinical setting, and results develop in real time without the help of a doctor or lab tech. The rapid antigen test for Covid-19 is an example of a point-of-care test. At-home diagnostic tests, while taken at home, are mailed to labs where technicians process results. At-home diagnostic tests are an extension of the healthcare system, while point-of-care tests require no medical oversight. Both are alternatives to at-home phlebotomy, in which a phlebotomist visits a user in his or her home to draw blood for lab analysis.
Photo: VioletaStoimenova, Getty Images
Emma Rayer is the Co-Founder and Head of Strategic Partnerships for Ash Wellness, a remote diagnostics solution that supports traditional healthcare systems, universities, public health initiatives, and digital health companies. As a South African, Emma saw firsthand the devastating effects of HIV and AIDS in local communities. In her first year at Ash Wellness, Emma and her team coordinated a pivotal partnership with a major PrEP provider to ship 10,000 monthly HIV self-tests. She has worked for Uber in South Africa and Just Eat UK to launch major rollouts, scale brand initiatives, and drive impact. Emma has a Masters in Branding & Integrated Communications from CCNY. She lives in New York with her husband and dog.
