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Self-collection, or specimens collected by the patient themselves, represents an innovative patient-centered strategy for expanding access to testing for infectious diseases. Over the past 2 decades, self-collection has demonstrated comparable or even superior performance relative to clinician-collected specimens for sexually transmitted infections (STIs) (1,2). While the uptake has been perhaps slower in the U.S. due to regulatory considerations, the SARS-CoV-2 pandemic in 2020 progressed the need for self-collected specimens, highlighting the practicality and potential to expand diagnostic reach. Self-collection of specimens for STI testing, including cervical cancer screening via human papillomavirus (HPV) molecular testing, shows promising results for expanding access to care (3).
For laboratorians, the task of implementing self-collected patient samples can seem formidable in terms of operationalization, regulatory compliance, and quality assurance. This article discusses key components of this process. While this discussion primarily focuses on self-collected specimens obtained in a clinic setting, many of the principles also apply to at-home collection. However, at-home collection introduces additional regulatory considerations, such as specimen stability, transport conditions, and temperature control, which are beyond the scope of this discussion.
Most laboratories have likely already been approached by clinicians or administrative leaders regarding the availability of self-collection for infectious disease testing. Within the last 2 years, the Food and Drug Administration has approved multiple self-collection devices and tests for HPV testing, leading to highlights in the news. Before introducing any new specimen type or test, however, laboratories must clarify expectations regarding test performance, turnaround time, projected test volumes, and staffing needs. Understanding these operational requirements is critical to developing a feasible and sustainable implementation plan.
The best way to gain this understanding is to engage early and often with colleagues who will be impacted by self-collection. For infectious disease self-collected specimens, this will include infectious disease physicians and those in outpatient clinics, especially primary care providers and OB/GYNs for STI and HPV testing. Engaging subject matter experts early in the process also ensures that the laboratory understands the clinical need and potential impact on patient care.
Your regulatory or accrediting agency may have specific guidance for self-collected specimens due to the potential for different preanalytical variables. Clinicians are trained to collect specimens consistently, whereas patients may have varying degrees of comfort and ability, potentially affecting specimen adequacy. For instance, a human target, serving as a control, may be necessary to confirm sufficient cellular material has been collected.
Verification or validation should be performed for each specimen type that will be acceptable for testing on an assay. Laboratories should refer to the regulatory minimum requirements, Clinical and Laboratory Standards Institute standards, or professional societies for guidance on the components to evaluate.
Labs should also pay special attention to standards that accreditation and regulatory bodies are implementing regarding patient instructions for self-collected specimens. The College of American Pathologists (CAP), for example, recently added the requirement for laboratories to provide clear written instructions for patient self-collection that explain both sample collection and proper handling (4).
The lab should take part in the creation of these specimen collection documents. While manufacturers may supply instructions in kit packaging, these materials may not always be user-friendly or accessible to all patients. Optimal patient instructions include stepwise procedures, visual aids, and language appropriate for the reading levels of the target population. Resources should also be available in multiple languages appropriate for the patient population. Labs should collaborate with patient-facing staff and institutional patient education content specialists to ensure the clarity and completeness of these instructions, as well as patient comprehension.
Operational planning is essential for smooth integration of self-collected specimens into laboratory workflows. Laboratory leadership should coordinate with clinical teams to ensure collection devices are available, appropriately stocked, and accessible in clinic areas. The laboratory information system should distinguish between clinician-collected and self-collected specimens for result reporting and for monitoring quality metrics.
Clear communication channels are critical for notifying affected parties about new test availability, workflow changes, and go-live dates. Utilizing established institutional communications, such as internal newsletters, email updates, or laboratory liaison programs, facilitates broad awareness and adoption of new processes among both clinical and laboratory staff.
Quality assurance is a cornerstone of laboratory operations, especially when new workflows and sample types are implemented. Standard operating procedures, job aids, and acceptance criteria must be updated to reflect new specimen types at implementation. Quality control plans should also be updated to include metrics relevant to self-collected specimens, such as rates of sample rejection or collection errors and invalid rates.
Tracking these metrics enables laboratories to identify trends, troubleshoot issues, and implement process improvements. A structured change-management approach, such as DMAIC (Define, Measure, Analyze, Improve, Control), can guide iterative improvements. For example, high invalid rates might prompt revisions to patient instructions or additional staff training. Regular review of quality metrics ensures the laboratory maintains high standards and supports patient-centered care.
Self-collection for infectious disease testing will continue to evolve testing strategies over the next decade. By enabling easier access to testing, self-collection aligns with broader public health goals and may reduce barriers to patients accessing healthcare. For laboratorians, successful implementation requires balancing patient-centered practices with rigorous scientific standards, regulatory compliance, and operational feasibility.
Allison Eberly, PhD, D(ABMM), is an associate professor at Washington University School of Medicine in St. Louis and a medical director of preanalytical microbiology and outreach, mycobacteriology, and sexual health molecular diagnostics at Barnes-Jewish Hospital. +Email: [email protected]
Read the full March-April 2026 issue of CLN.
Demystifying the DCLS degree
Jan 1, 2026
Laboratory support for emergency department drug testing
Jan 1, 2026
Does provoked VTE warrant thrombophilia testing?
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