(P350) Clinic-Based Hands-On Time and Time to Result for Point of Care Chlamydia and Gonorrhea Test Compared to Laboratory Based Test

Wednesday, July 26, 2023

16:00 – 18:00 CST

Primary Presenter(s)

KR

Kelsey L. Rowe

Cincinnati Children's Hospital and Medical Center, United States

Co-author(s)

HW

Hannah E. Woods, BA

Clinical Research Coordinator
Cincinnati Children's Hospital and Medical Center
Milford, Ohio, United States
AS

Aaron M. Schuh, MD

Adolescent Medicine Clinical Fellow
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
CG

Charlotte A. Gaydos, BS, MS, MPH, DrPH

Professor
Johns Hopkins University
Gettysburg, Pennsylvania, United States
YM

Yukari C. Manabe, MD

Department of Medicine, Johns Hopkins University, Baltimore, MD, United States
LW

Lea E. Widdice

Cincinnati Children's Hospital and Medical Center, United States

Background: Implementing point-of-care tests (POCT) for chlamydia and gonorrhea (CT/NG) into clinical settings may disrupt clinic flow and divert staff away from established duties. Adoption of POCTs into settings where clinical staff operate POCTs will depend on device assay turnaround time as well as the time required for clinical staff to operate the device.. The purpose of this study was to record hands-on time and time-to-results for binx health io® [Cambridge, MA] (binx io) CT/NG assay and compare to laboratory-based CT/NG testing.

Methods: This study was conducted in a clinic that provides care to adolescents. This IRB-approved, continuous-operation time-motion study used video recordings of two non-laboratory operators testing vaginal swabs and urine using the binx io. Milestone intervals (measured in minutes [min] and seconds [s]) included staff hands-on time (preparing sample and starting the assay), assay time (touching “run test” to “view results”), and time to result (preparing sample, starting the assay, and assay time). Comparison of staff hands-on-time to operate the binx io and prepare and send nine vaginal samples to the laboratory for CT/NG testing used data obtained through direct observation by two trained observers of six clinical staff. Hands-on time for preparing urine samples for standard of care testing was not available.

Results: A total of 57 binx io tests with complete data were analyzed: 38 vaginal, 19 urine samples. On average, binx io time-to-result was 34min 3s (SD 20s) for vaginal and 34min 58s (SD 34s) for urine samples. An average of 1min 29s (SD 21s) hands-on time was required for preparing vaginal samples and 2min 25s (SD 34s) for urine samples. For clinical laboratory samples, the average time to prepare and send vaginal swabs was 1min 8s (SD 33s). There was no statistically significant difference between hands-on-time needed to operate binx io and prepare and send vaginal samples to the laboratory (two sample t-test, p=NS).

Conclusion: When implementing binx io CT/NG into clinical settings, staff tasks may change, but the time away from other duties is similar to laboratory-based testing. Results are available in less than 35 minutes after the sample is obtained.