O9.1. SATISFACTION WITH USING A NOVEL FINGERSTICK FOR ABSOLUTE NEUTROPHIL COUNT (ANC) AT THE POINT OF TREATMENT IN PATIENTS TREATED WITH CLOZAPINE
Authors: Kelly Deanna , Glassman Matthew , Mackowick Marie , Park Jae , Navarro-De La Vega Myriam , Wehring Heidi , Vyas Gopal , Richardson Charles 
Published: May 2020

Abstract

Background
Clozapine is an effective antipsychotic for treatment-resistant schizophrenia that requires monitoring of the Absolute Neutrophil Count (ANC) due to the potential of clozapine induced neutropenia. Standard monitoring requires a routine venous draw which is considered one of the most significant barriers to patients starting or continuing the medication. This project assesses the feasibility, patient and clinician satisfaction with both venous blood drawing for ANC monitoring and a novel method for measuring ANC with a fingerstick using capillary blood.

Methods
During an open-label clinical trial of clozapine, participants with schizophrenia received both a venous blood draw and a capillary finger stick at baseline, week 2 and week 4. Capillary testing was done onsite using the newly FDA Class II cleared automated diagnostic device. This device performs tests on capillary finger stick samples collected directly into the provided test strip. This works by using a microfluidic test strip channel that creates a stained monolayer of white blood cells. Multiple images are taken of the monolayer and the cells are counted and classified by computer vision-based image analysis on a cloud server. This device offers technology that provides ANC results within 5 minutes using a small drop of blood drawn in the clinic and has been found to have a correlation to reference lab results of &gt;0.94 in over 30, 000 testings.
We measured patient satisfaction using a questionnaire with a 5-point Likert Scale rating domain of pain, worry, concern about blood volume, concern for where blood is sent and irritation with blood drawing and we anonymously measured clinical team members satisfaction with an anonymous survey. The study was conducted at two sites (one inpatient hospital and one research clinic) and approved by the Institutional Review Board at the University of Maryland and respective research committees.

Results
We enrolled 20 participants and 20 clinical team members for the surveys. Most patients believe the doctor is able to provide better care given immediate results. They also feel the elimination of unknown people touching the blood is a benefit of fingerstick monitoring. Patients indicated that they are more likely to remain on clozapine with fingerstick testing versus venous testing. There was a trend for higher agreement that using the venous blood draw negatively impacts their health (3.2 vs 2.8, p=0.068). In terms of pain, patients indicated that venous blood monitoring was slightly painful and more worrisome than fingerstick monitoring. Clinician ratings are high with mean scores &gt;4 for satisfaction with device, satisfaction with immediate results, advancement in treatment, and improved patient care.

Discussion
The device is very user friendly and technology appears to be a significant advance for clinicians. Patients do not appear to worry about having venous blood draws or fingersticks but rate their most significant concern with venous blood draws is its negative effect on their health. However, patients strongly feel the fingerstick helps their doctors and their care. The use of POC devices may decrease or eliminate a significant barrier and may help improve the use of this underused evidence-based medication.
Funding: This project was funded by NIMH R01MH102215 (Kelly PI). Athelas provided the Athelas One devices for two locations but provided no funding for the project.