A-192 You*re So Vein: A Comparative Analysis of Capillary Collection Devices

Background

Several capillary blood collection technologies have emerged in the past decade to address the increased demand for patient-centric sampling solutions. However, no definitive study has systematically evaluated the relative advantages and disadvantages of these devices. This research addresses that gap by conducting a head-to-head investigation of several capillary blood collection technologies, including examining performance of each device through analytical clinical assays and assessing factors such as sample quality and volume collected, subject preference, and post-draw wound scarring.

Methods

One standard venipuncture and five capillary blood specimens were collected from 41 subjects. Capillary collections included a fingerstick with a high flow lancet (BD 366594) and three FDA 510(k)-cleared class II lancets typically utilized on the upper arm: RedDropTM ONE, Tasso+®, and YourBio Health’s TAP® Micro Select. An upper arm collection technology developed by Labcorp used in conjunction with an adult lancet (gentleheel® lancet, GHT10X50) was also investigated. All capillary samples were collected into a BD Microtainer® SST tube, and the skin pre-warming technique was standardized to reduce potential biases. All collections were performed by trained professionals to reduce variability associated with self-collection by lay users.

In addition to capturing collection time and volume of sample collected, subjects provided subjective pain scores (0 = no pain, 10 = extreme pain) and preference ranking of each collection technique (1 = most preferred, 6 = least preferred). Subjects also provided two follow-up assessments of wound scarring/scabbing. Finally, sample hemolysis, a comprehensive metabolic panel, lipid panel, and high-sensitivity C-reactive protein were measured on samples using Roche cobas® analyzers.

Results

The upper arm collection technologies produced mean pain ratings ranging from 0.5 to 1.8 while fingerstick and venipuncture produced mean pain ratings of 2.5 and 1.5, respectively (out of 10). The upper arm collection technologies were, in general, preferred 71.8% of the time with mean rankings from 2.2 to 3.7 while venipuncture was preferred the remaining 28.2% with a mean ranking of 3.4 (out of 6). Fingerstick collections were not preferred by any subjects and had a mean ranking of 5.5. The ability to collect at least 400 µL of blood (in = 5 minutes) ranged from 41.5 to 90.2% for the upper arm collection technologies and 70.7% for fingerstick collections. Assessment of sample quality produced hemolysis indices ranging from 6.9 to 20.8 for the upper arm collection technologies, 17.8 for fingerstick collections, and 5.9 for venous samples. Analytical measurements from each capillary collection technology produced agreements (with respect to CLIA acceptance limits) to venous results at least 90% of the time except for carbon dioxide (50.0-86.7%), glucose (35.7-72.7%), potassium (36.8-90.3%), sodium (85.7-96.6%), and triglycerides (71.1-83.8%).

Conclusion

Samples collected via fingerstick were generally the least preferred method and produced the most hemolysis although still acceptable for most measurements. Investigation of the upper arm collection technologies did not appear to produce a clear “winner” as each technology displayed both advantages and disadvantages.