B-242 Improved Patient Satisfaction With Novel Capillary Blood Collection Devices as an Alternative to Venipuncture for Applications in Clinical Proteomic Assays
Authors: Flohrschutz D , Richard A , Patrick A , Kifer C , Dvorak D , O’Brien M , Givens N , Phillips S , Whitted S , Pestano G , Peek L 
Published: October 2024

Abstract

Background
Two new clinical diagnostic tests are available that aid in the identification of lung nodules as likely malignant or likely benign. One test is an ELISA that measures the levels of seven autoantibodies to tumor-associated antigens that aids in the identification of patients with likely malignant lung nodules who may benefit from timely intervention. The other is an LC-MS/MS-based (MRM) test that measures the ratio of two proteins (LG3BP and C163A) combined with several clinical and radiological factors to aid in the identification of patients with likely benign lung nodules who may benefit from additional CT surveillance. Since commercialization, we have found that test access may be improved by providing alternatives to traditional venipuncture. Therefore, we conducted evaluation studies with two novel non-fingerstick capillary blood collection devices. These devices puncture the skin by utilizing either microneedles (Device A) or a lancet (Device B) for capillary blood collection.

Methods
Blood specimens were collected from consented donors using one of the two capillary blood collection devices and by venipuncture into K2EDTA blood collection tubes. Feedback was also solicited from the healthcare professionals and donors via a standard questionnaire. The whole blood specimens were shipped to the testing laboratory where the samples were processed according to the respective clinical assay workflows. Feasibility testing for the ELISA-based assay was conducted with both devices using normal healthy donor specimens (105 donors for Device A and 43 for Device B). Clinical evaluation was executed utilizing only Device B (77 donors with lung cancer and 13 with an indeterminate lung nodule). Feasibility testing for the LC-MS/MS-based assay was conducted with both devices using healthy donor specimens (103 donors for Device A and 41 for Device B), while clinical evaluation utilized only Device B (80 donors with lung cancer and 30 with an indeterminate lung nodule).

Results
Both capillary blood collection devices revealed good correlations to venous blood draws for the ELISA-based test during feasibility. The two devices also showed good correlations for the LC-MS/MS-based test, with the results from Device A requiring a correction factor. Due to technical and operational challenges throughout feasibility, Device B became the preferred device to be evaluated for the clinical study. Good correlations for both diagnostic tests were observed from the clinical study.
During clinical evaluation, healthcare professionals and donors were asked to rate the ease-of-use, pain, and speed of collection when using Device B. Most healthcare professionals (108/126) rated the device as easy to use. Ninety-five percent of the donors reported minimal pain while the remainder reported moderate pain. Ninety-one percent of the donors felt that the time required to collect blood using Device B was acceptable. Sixty percent of the donors preferred the capillary collection device (Device B), 17% preferred venipuncture, while 23% reported no preference for blood collection.

Conclusions
The novel capillary blood collection devices demonstrated high correlations for two clinical diagnostic tests. Feedback collected from healthcare professionals and donors revealed that the majority preferred the capillary blood collection device as compared to traditional venipuncture for blood collection.