To Boldly Go Where No Device Has Gone Before: Specimen Self-Collection for the Clinical Laboratory

Abstract

The indications for and interest in self-collection of specimens, such as blood, saliva, urine, stool, and anogenital specimens, for clinical laboratory testing are vast (especially in the post-pandemic era). 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. Many of the devices discussed in this review are registered by the U.S. Food and Drug Administration (FDA) or have emergency use authorization for diagnostic testing in clinical laboratories. While many self-collection devices were evaluated for collection of specimens for SARS-CoV-2 testing, they can be used to collect samples for many other serologic, molecular, or other diagnostic methods following completion of necessary laboratory validation studies. The advantages of these devices, such as convenience and access, must be balanced with added cost, challenges of specimen stability, and manual processing in the laboratory, all of which are discussed in this review.