Collect It Yourself: Putting Innovations and Advances in Self-Collection Devices Into Practice

Use of self-collection devices has skyrocketed in the past 3 years, largely driven by the COVID-19 pandemic, causing an increased need for innovation in specimen collection to avoid unnecessary contact. As a result, consumers have become much more accustomed to collecting their own specimens, including saliva, blood, and urine.

“A need for innovation, combined with convenience for patients, clinicians, and researchers, opened the doors for a wave of self-collection devices to flood the market in early 2020,” says Ria Fyffe-Freil, PhD, a clinical chemistry fellow at the Mayo Clinic in Minnesota.

While initially evaluated for SARS-CoV-2 testing, self-collection devices can also be used for many other serologic, molecular, or other diagnostics methods following completion of necessary laboratory-validation studies, she explains.

Examples of such devices include the Tasso-SST device, which uses a lancet to obtain capillary blood from the upper arm; the Drawbridge OneDraw device, which uses a gel adhesive attached to either the upper arm or thigh to collect capillary blood through a small cutaneous incision; the Salimetrics Saliva Collection Aid for PCR testing; and the Novosanis Colli-Pee device for HPV testing.

Self-collection devices can be useful in therapeutic drug monitoring, diagnosing sexually transmitted infections, and identifying respiratory infections, says Dr. Fyffe-Freil. New self-collection devices are continually entering the market, which presents some challenges for clinical laboratories, she says. One of the main challenges is validating the self-collection device and specimen integrity. For example, will self-collected blood specimens have an acceptably low degree of hemolysis? Will the shipping process introduce unanticipated sources of variation that may affect the results?

“The clinician will tell the patient to self-collect a sample with a kit, but the lab has to determine if it can actually test the sample,” she explains. “Is there sufficient volume for testing? Are the samples good enough quality? Will the collection tube fit on the lab’s system? In some cases, there may be more manual work required to run the sample.”

Dr. Fyffe-Freil emphasizes that it is essential for clinicians and laboratory leadership to be in direct communication about self-collection devices, regardless of the target analyte. This includes discussing when and whether to implement new devices as well as evaluating the acceptability of current self-collection devices.

Given that self-collection of samples is likely to increase, Dr. Fyffe-Freil believes it is useful for laboratorians to be familiar with the self-collection devices, to review their performance characteristics for select assays compared to professional collection, and to discuss the challenges associated with specimen self-collection.

Ultimately, the advantages of self-collection devices, such as convenience and access, must be balanced against added cost, the challenges of specimen stability, and the need for manual processing in the laboratory, she says.

Dr. Fyffe-Freil will discuss these issues on July 24 during a roundtable session, Collect It Yourself! Putting Innovations and Advances in Self-Collection Devices into Practice, at the 2023 AACC Annual Scientific Meeting & Clinical Lab Expo. The audience can expect to learn the answers to the questions:

• What are common self-collection devices for blood, saliva, sputum, and anogenital specimens?
• What are the advantages and disadvantages of each class of device?
• What are testing applications for which these devices are appropriate in both the chemistry and microbiology labs?

Kimberly Scott is a freelance writer who lives in Lewes, Delaware. +Email: [email protected]