Publication

Head-to-head comparison of three stool calprotectin tests for home use

Haisma, S-M., Galaurchi, A., Almahwzi, S., Balogun, J. A. A., Kobold, A. C. M. & van Rheenen, P. F., 18-Apr-2019, In : PLoS ONE. 14, 4, 14 p., 0214751.

Research output: Contribution to journalArticleAcademicpeer-review

Objective

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.

Design

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.

Results

We performed 1440 smartphone readings and 120 ELISA tests. In the low calprotectin range ( 500 mu g/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.

Conclusions

All three calprotectin home tests and companion ELISAs agreed sufficiently when concentrations are. 500 mu g/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.

Original languageEnglish
Article number0214751
Number of pages14
JournalPLoS ONE
Volume14
Issue number4
Publication statusPublished - 18-Apr-2019

    Keywords

  • INFLAMMATORY-BOWEL-DISEASE, FECAL CALPROTECTIN, TELEMEDICINE, MULTICENTER, MANAGEMENT, CROHNS

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