Evaluation of a Simplified Upper Arm Device for Vacuum-Assisted Collection of Capillary Blood Specimens
<b>Background/Objectives:</b> Conventional blood collection can be challenging in a non-clinical or home-based setting. In response, vacuum-assisted lancing devices for capillary blood collection (typically from the upper arm) have gained popularity to broaden access to diagnostic testin...
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MDPI AG
2025-07-01
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| author | Ulrich Y. Schaff Bradley B. Collier Gabriella Iacovetti Mitchell Peevler Jason Ragar Nicolas Tokunaga Whitney C. Brandon Matthew R. Chappell Russell P. Grant Greg J. Sommer |
| author_facet | Ulrich Y. Schaff Bradley B. Collier Gabriella Iacovetti Mitchell Peevler Jason Ragar Nicolas Tokunaga Whitney C. Brandon Matthew R. Chappell Russell P. Grant Greg J. Sommer |
| author_sort | Ulrich Y. Schaff |
| collection | DOAJ |
| description | <b>Background/Objectives:</b> Conventional blood collection can be challenging in a non-clinical or home-based setting. In response, vacuum-assisted lancing devices for capillary blood collection (typically from the upper arm) have gained popularity to broaden access to diagnostic testing. However, these devices are often costly relative to the reimbursement rate for common laboratory testing panels. This study describes the design and evaluation of Comfort Draw™, a simplified and economical vacuum-assisted capillary blood collection device. <b>Methods:</b> Comfort Draw™ was evaluated by 12 participants in a preliminary study and by 42 participants in a follow-up study. Metrics assessed included the following: vacuum pressure of the device, skin temperature generated by the Comfort Draw prep warmer, blood collection volume, and analytical accuracy (for 19 common serum-based analytes). <b>Results:</b> Acceptable blood volume (>400 µL) and serum volume (>100 µL) were collected by Comfort Draw in 85.5% and 95.1% of cases, respectively. Seventeen of the nineteen analytes examined were within CLIA acceptance limits compared to matched venous samples. Self-reported pain scores associated with Comfort Draw collection averaged 0.39 on a scale from 0 to 10. <b>Conclusions:</b> In this preliminary clinical study, Comfort Draw was found to be a valid and relatively painless method for collecting capillary blood specimens. The device’s simple design and lower cost could enable broader applications compared to more complex alternative capillary blood collection devices. |
| format | Article |
| id | doaj-art-89f24d371d994e27b119e7e9cf591dae |
| institution | Kabale University |
| issn | 2075-4418 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Diagnostics |
| spelling | doaj-art-89f24d371d994e27b119e7e9cf591dae2025-08-20T03:36:31ZengMDPI AGDiagnostics2075-44182025-07-011515193510.3390/diagnostics15151935Evaluation of a Simplified Upper Arm Device for Vacuum-Assisted Collection of Capillary Blood SpecimensUlrich Y. Schaff0Bradley B. Collier1Gabriella Iacovetti2Mitchell Peevler3Jason Ragar4Nicolas Tokunaga5Whitney C. Brandon6Matthew R. Chappell7Russell P. Grant8Greg J. Sommer9Diagnostic Devices Research and Development, Labcorp, Pleasanton, CA 94588, USACenter for Esoteric Testing, Labcorp, Burlington, NC 27215, USADiagnostic Devices Research and Development, Labcorp, Pleasanton, CA 94588, USADiagnostic Devices Research and Development, Labcorp, Pleasanton, CA 94588, USADiagnostic Devices Research and Development, Labcorp, Pleasanton, CA 94588, USADiagnostic Devices Research and Development, Labcorp, Pleasanton, CA 94588, USACenter for Esoteric Testing, Labcorp, Burlington, NC 27215, USACenter for Esoteric Testing, Labcorp, Burlington, NC 27215, USACenter for Esoteric Testing, Labcorp, Burlington, NC 27215, USADiagnostic Devices Research and Development, Labcorp, Pleasanton, CA 94588, USA<b>Background/Objectives:</b> Conventional blood collection can be challenging in a non-clinical or home-based setting. In response, vacuum-assisted lancing devices for capillary blood collection (typically from the upper arm) have gained popularity to broaden access to diagnostic testing. However, these devices are often costly relative to the reimbursement rate for common laboratory testing panels. This study describes the design and evaluation of Comfort Draw™, a simplified and economical vacuum-assisted capillary blood collection device. <b>Methods:</b> Comfort Draw™ was evaluated by 12 participants in a preliminary study and by 42 participants in a follow-up study. Metrics assessed included the following: vacuum pressure of the device, skin temperature generated by the Comfort Draw prep warmer, blood collection volume, and analytical accuracy (for 19 common serum-based analytes). <b>Results:</b> Acceptable blood volume (>400 µL) and serum volume (>100 µL) were collected by Comfort Draw in 85.5% and 95.1% of cases, respectively. Seventeen of the nineteen analytes examined were within CLIA acceptance limits compared to matched venous samples. Self-reported pain scores associated with Comfort Draw collection averaged 0.39 on a scale from 0 to 10. <b>Conclusions:</b> In this preliminary clinical study, Comfort Draw was found to be a valid and relatively painless method for collecting capillary blood specimens. The device’s simple design and lower cost could enable broader applications compared to more complex alternative capillary blood collection devices.https://www.mdpi.com/2075-4418/15/15/1935microsamplingcapillary blood collectionalternative phlebotomy methodpain-free phlebotomydifficult venous access |
| spellingShingle | Ulrich Y. Schaff Bradley B. Collier Gabriella Iacovetti Mitchell Peevler Jason Ragar Nicolas Tokunaga Whitney C. Brandon Matthew R. Chappell Russell P. Grant Greg J. Sommer Evaluation of a Simplified Upper Arm Device for Vacuum-Assisted Collection of Capillary Blood Specimens Diagnostics microsampling capillary blood collection alternative phlebotomy method pain-free phlebotomy difficult venous access |
| title | Evaluation of a Simplified Upper Arm Device for Vacuum-Assisted Collection of Capillary Blood Specimens |
| title_full | Evaluation of a Simplified Upper Arm Device for Vacuum-Assisted Collection of Capillary Blood Specimens |
| title_fullStr | Evaluation of a Simplified Upper Arm Device for Vacuum-Assisted Collection of Capillary Blood Specimens |
| title_full_unstemmed | Evaluation of a Simplified Upper Arm Device for Vacuum-Assisted Collection of Capillary Blood Specimens |
| title_short | Evaluation of a Simplified Upper Arm Device for Vacuum-Assisted Collection of Capillary Blood Specimens |
| title_sort | evaluation of a simplified upper arm device for vacuum assisted collection of capillary blood specimens |
| topic | microsampling capillary blood collection alternative phlebotomy method pain-free phlebotomy difficult venous access |
| url | https://www.mdpi.com/2075-4418/15/15/1935 |
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