Department of Paediatric Gastroenterology Hepatology and Nutrition, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
Department of Laboratory Medicine, University of Groningen, University Medical Centre Groningen, Groningen, the Netherlands.
PLoS One. 2019 Apr 18;14(4):e0214751. doi: 10.1371/journal.pone.0214751. eCollection 2019.
Treatment decisions in inflammatory bowel diseases are increasingly based on longitudinal tracking of calprotectin results. Many hospital laboratories measure calprotectin levels in sent-in stool samples with an enzyme-linked immunosorbent assay (ELISA). Several manufacturers introduced a lateral flow-based test with software application that turns a smartphone camera into a reader for quantitative measurements. We compared three home tests (IBDoc, QuantonCal and CalproSmart) and companion ELISA tests (fCAL, IDK-Calprotectin and Calprotectin-ALP) to see if measurement pairs agreed sufficiently.
A method comparison study was conducted with stool samples from patients with active or quiescent inflammatory bowel disease. Medical students without any specific laboratory training carried out the home tests with two iOS (iPhone 6 and 7) and two Android devices (Samsung Galaxy S6 and Motorola Moto G5 Plus). Two experienced laboratory technicians measured the calprotectin concentration with the ELISA method. Primary outcome was test agreement (defined as percentage of paired measurements within predefined limits of difference). Secondary outcome included reading error rate (RER) per smartphone type.
We performed 1440 smartphone readings and 120 ELISA tests. In the low calprotectin range (≤500 μg/g) IBDoc, QuantOnCal and CalproSmart showed 87%, 82% and 76% agreement with their companion ELISAs. In the high range (>500 μg/g) the agreement was 37%, 19% and 37%, respectively. CalproSmart and QuantOnCal had significantly higher RERs than IBDoc (respectively 5.8% and 4.8%, versus 1.9%). Forty-three percent of reading errors was on the Motorola device, in particular with the QuantOnCal application.
All three calprotectin home tests and companion ELISAs agreed sufficiently when concentrations are ≤500 μg/g. To minimize wrongful interpretation of calprotectin changes over time it is essential to always use the home test and companion ELISA of one and the same manufacturer. Manufacturers should explicitly evaluate and report the suitability of commonly used smartphones for quantitative calprotectin readings.
炎症性肠病的治疗决策越来越基于钙卫蛋白结果的纵向跟踪。许多医院实验室使用酶联免疫吸附测定法（ELISA）测量送检粪便样本中的钙卫蛋白水平。有几个制造商引入了一种基于横向流动的测试，带有软件应用程序，可以将智能手机摄像头变成定量测量的读取器。我们比较了三种家用测试（IBDoc、QuantonCal 和 CalproSmart）和配套的 ELISA 测试（fCAL、IDK-Calprotectin 和 Calprotectin-ALP），以观察测量对是否足够一致。
对患有活动性或静止性炎症性肠病的患者的粪便样本进行了方法比较研究。没有任何特定实验室培训的医学生使用两个 iOS（iPhone 6 和 7）和两个 Android 设备（三星 Galaxy S6 和摩托罗拉 Moto G5 Plus）进行了家用测试。两名经验丰富的实验室技术员使用 ELISA 方法测量钙卫蛋白浓度。主要结果是测试一致性（定义为在预先设定的差异限值内的配对测量百分比）。次要结果包括每个智能手机类型的读数错误率（RER）。
我们进行了 1440 次智能手机读数和 120 次 ELISA 测试。在低钙卫蛋白范围（≤500μg/g）下，IBDoc、QuantonCal 和 CalproSmart 与其配套 ELISA 的一致性分别为 87%、82%和 76%。在高范围（>500μg/g）时，一致性分别为 37%、19%和 37%。CalproSmart 和 QuantOnCal 的 RER 明显高于 IBDoc（分别为 5.8%和 4.8%，而 IBDoc 为 1.9%）。43%的读数错误发生在摩托罗拉设备上，特别是在使用 QuantOnCal 应用程序时。
当浓度≤500μg/g 时，所有三种钙卫蛋白家用测试和配套 ELISA 都足够一致。为了最小化对钙卫蛋白随时间变化的错误解释，务必始终使用同一制造商的家用测试和配套 ELISA。制造商应明确评估和报告常用智能手机进行定量钙卫蛋白读数的适用性。
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