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

Sjoukje-Marije Haisma; Anne Galaurchi; Shatha Almahwzi; Joy A. Adekanmi Balogun; Anneke C. Muller Kobold; Patrick F. van Rheenen

doi:10.1371/journal.pone.0214751

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

Sjoukje-Marije Haisma, Anne Galaurchi, Shatha Almahwzi, Joy A. Adekanmi Balogun, Anneke C. Muller Kobold, Patrick F. van Rheenen^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

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 language	English
Article number	0214751
Number of pages	14
Journal	PLoS ONE
Volume	14
Issue number	4
DOIs	https://doi.org/10.1371/journal.pone.0214751
Publication status	Published - 18-Apr-2019

Keywords

INFLAMMATORY-BOWEL-DISEASE
FECAL CALPROTECTIN
TELEMEDICINE
MULTICENTER
MANAGEMENT
CROHNS

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Dataset: Head-to-head comparison of three stool calprotectin tests for home use
Haisma, S. (Contributor), Galaurchi, A. (Contributor), Almahwzi, S. (Contributor), Adekanmi Balogun, J. (Contributor), Muller Kobold, A. (Contributor) & van Rheenen, P. (Contributor), DataverseNL, 2-Apr-2019
DOI: 10.34894/fqltnc
Dataset

Cite this

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title = "Head-to-head comparison of three stool calprotectin tests for home use",

abstract = "ObjectiveTreatment 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.DesignA 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.ResultsWe 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.ConclusionsAll 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.",

keywords = "INFLAMMATORY-BOWEL-DISEASE, FECAL CALPROTECTIN, TELEMEDICINE, MULTICENTER, MANAGEMENT, CROHNS",

author = "Sjoukje-Marije Haisma and Anne Galaurchi and Shatha Almahwzi and Balogun, {Joy A. Adekanmi} and Kobold, {Anneke C. Muller} and {van Rheenen}, {Patrick F.}",

year = "2019",

month = apr,

day = "18",

doi = "10.1371/journal.pone.0214751",

language = "English",

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T1 - Head-to-head comparison of three stool calprotectin tests for home use

AU - Haisma, Sjoukje-Marije

AU - Galaurchi, Anne

AU - Almahwzi, Shatha

AU - Balogun, Joy A. Adekanmi

AU - Kobold, Anneke C. Muller

AU - van Rheenen, Patrick F.

PY - 2019/4/18

Y1 - 2019/4/18

N2 - ObjectiveTreatment 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.DesignA 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.ResultsWe 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.ConclusionsAll 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.

AB - ObjectiveTreatment 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.DesignA 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.ResultsWe 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.ConclusionsAll 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.

KW - INFLAMMATORY-BOWEL-DISEASE

KW - FECAL CALPROTECTIN

KW - TELEMEDICINE

KW - MULTICENTER

KW - MANAGEMENT

KW - CROHNS

U2 - 10.1371/journal.pone.0214751

DO - 10.1371/journal.pone.0214751

M3 - Article

SN - 1932-6203

VL - 14

JO - PLoS ONE

JF - PLoS ONE

IS - 4

M1 - 0214751

ER -

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

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