Choi Karam, Chang Ikwan, Lee Jung Chan, Kim Do Kyun, Noh Seungwoo, Ahn Heejeong, Cho Jun Hwi, Kwak Young Ho, Kim Sungwan, Kim Hee Chan
1 Interdisciplinary Program in Bioengineering, Seoul National University Graduate School , Seoul, Republic of Korea.
2 Department of Emergency Medicine, Seoul National University Hospital , Seoul, Republic of Korea.
Telemed J E Health. 2016 Jun;22(6):534-40. doi: 10.1089/tmj.2015.0153. Epub 2016 Jan 26.
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).
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.
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).
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.
尽管智能手机可用于尿液试剂条检测,但很少有研究报道该检测在临床环境中的可靠性。我们研究的目的是在临床急诊科评估基于智能手机的尿液试剂条检测。
我们开发了一种基于智能手机的尿液试剂条阅读器,用于快速准确地筛查尿液中的白细胞酯酶(LE)和亚硝酸盐(NIT)。使用临床尿液样本(n = 81)对开发的阅读器进行评估。评估阅读器对LE和NIT的检测性能以评估其可靠性;还计算分析的周转时间(TAT)和整个研究过程的时间以评估阅读器效率。使用一台光度分析仪(型号US - 3100R Plus(®);日本东京荣化学有限公司)作为参考。
所提出的阅读器显示出高准确性(LE为85.2%,NIT为97.5%),与真实值显示出高度一致性(LE的κ = 0.903;NIT的κ = 1.000)。该阅读器分析的中位TAT也低于光度分析仪(3.0分钟对33.0分钟;p < 0.001)。考虑到将尿液样本送到光度分析仪所需的时间,阅读器TAT的减少更为明显(3.0分钟对62.0分钟;p < 0.001)。
我们的结果证明了基于智能手机的尿液试剂条检测的临床能力,并且预计该阅读器能够在临床环境和护理点实现更快速可靠的比色检测,用于筛查LE和NIT。