Karam Choi1, Ikwan Chang2, Jung Chan Lee3,4,5, Do Kyun Kim2, Seungwoo Noh1, Heejeong Ahn2, Jun Hwi Cho6, Young Ho Kwak2, Sungwan Kim3,4,5, Hee Chan Kim3,4,5. 1. 1 Interdisciplinary Program in Bioengineering, Seoul National University Graduate School , Seoul, Republic of Korea. 2. 2 Department of Emergency Medicine, Seoul National University Hospital , Seoul, Republic of Korea. 3. 3 Department of Biomedical Engineering, Seoul National University College of Medicine , Seoul, Republic of Korea. 4. 4 Institute of Medical & Biological Engineering, Medical Research Center, Seoul National University , Seoul, Republic of Korea. 5. 5 Department of Biomedical Engineering, Seoul National University Hospital , Seoul, Republic of Korea. 6. 6 Department of Emergency Medicine, Kangwon National University Hospital , Seoul, Republic of Korea.
Abstract
BACKGROUND: Although a smartphone could be used for a urine reagent strip test, few studies have reported on the reliability of the test in a clinical setting. The objective of our study was to access the smartphone-based urine reagent strip test in the clinical emergency department (ED). MATERIALS AND METHODS: We developed a smartphone-based urine reagent strip reader for a rapid and accurate screening of leukocyte esterase (LE) and nitrite (NIT) in urine. The developed reader was evaluated with the clinical urine samples (n = 81). The detection performance of the reader for LE and NIT was evaluated to assess reliability of the reader; turnaround times (TATs) for analysis and the time for the entire study procedure were also calculated to assess the efficiency of the reader. A photometric analyzer (model US-3100R Plus(®); Eiken Chemical, Ltd., Tokyo, Japan) was used as a reference. RESULTS: The proposed reader showed high accuracy (85.2% for LE and 97.5% for NIT), exhibiting close agreement with the true values (κ = 0.903 for LE; κ = 1.000 for NIT). The reader also exhibited a lower median TAT for analysis than the photometric analyzer (3.0 min versus 33.0 min; p < 0.001). This reduction of TAT in the reader was even more evident considering the required time for delivery of urine samples for the photometric analyzer (3.0 min versus 62.0 min; p < 0.001). CONCLUSIONS: Our results demonstrated the clinical capability of a smartphone-based urine reagent strip test, and this reader is expected to enable a more rapid and reliable colorimetric test for screening of LE and NIT at the clinical setting and the point of care.
BACKGROUND: Although a smartphone could be used for a urine reagent strip test, few studies have reported on the reliability of the test in a clinical setting. The objective of our study was to access the smartphone-based urine reagent strip test in the clinical emergency department (ED). MATERIALS AND METHODS: We developed a smartphone-based urine reagent strip reader for a rapid and accurate screening of leukocyte esterase (LE) and nitrite (NIT) in urine. The developed reader was evaluated with the clinical urine samples (n = 81). The detection performance of the reader for LE and NIT was evaluated to assess reliability of the reader; turnaround times (TATs) for analysis and the time for the entire study procedure were also calculated to assess the efficiency of the reader. A photometric analyzer (model US-3100R Plus(®); Eiken Chemical, Ltd., Tokyo, Japan) was used as a reference. RESULTS: The proposed reader showed high accuracy (85.2% for LE and 97.5% for NIT), exhibiting close agreement with the true values (κ = 0.903 for LE; κ = 1.000 for NIT). The reader also exhibited a lower median TAT for analysis than the photometric analyzer (3.0 min versus 33.0 min; p < 0.001). This reduction of TAT in the reader was even more evident considering the required time for delivery of urine samples for the photometric analyzer (3.0 min versus 62.0 min; p < 0.001). CONCLUSIONS: Our results demonstrated the clinical capability of a smartphone-based urine reagent strip test, and this reader is expected to enable a more rapid and reliable colorimetric test for screening of LE and NIT at the clinical setting and the point of care.
Authors: Madeleine Flaucher; Michael Nissen; Katharina M Jaeger; Adriana Titzmann; Constanza Pontones; Hanna Huebner; Peter A Fasching; Matthias W Beckmann; Stefan Gradl; Bjoern M Eskofier Journal: IEEE J Transl Eng Health Med Date: 2022-05-30