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SHR Neuro Cancer Cardio Lipid Metab Microb
Michaelis, S; Hochfellner, A; Schneider, C; Schnedl, WJ; Baranyi, A; Enko, D.
Performance evaluation of a smartphone-based home test for fecal calprotection.
Clin Chem Lab Med. 2025; 63(1):139-146
Doi: 10.1515/cclm-2024-0422
Web of Science
PubMed
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FullText_MUG
- Leading authors Med Uni Graz
- Michaelis Simon
- Co-authors Med Uni Graz
- Baranyi Andreas
- Enko Dietmar
- Schnedl Wolfgang
- Schneider Christopher
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- Abstract:
- OBJECTIVES: Fecal calprotectin (FC) serves as a non-invasive marker for the assessment of gut inflammation in patients with inflammatory bowel disease (IBD). Laboratory measurements are usually performed with immunologic methods like enzyme-linked immunosorbent assay. Recently, quantitative home tests based on the lateral flow technology with smartphones as read-out devices have been developed. We compared the quantitative and qualitative performance of the quantitative lateral flow home test Preventis SmarTest® Calprotectin Home and the immunological test used in our laboratory (Eurospital Calprest® Turbo). METHODS: Fourty-five routine samples were analyzed in parallel with both tests according to the manufacturer's instructions. The read-out of the home test was performed with two smartphones (Apple iPhone 14 Pro and Samsung Galaxy XCover 5). The qualitative interpretation (positive, negative, borderline) was conducted using the cut-offs provided by the manufacturers. RESULTS: Statistically significant correlations with the laboratory standard method were observed for both smartphones (Spearman's rho 0.703 and 0.715, all p<0.005). The home test showed systematically higher concentrations compared to the routine assay. We found minimal qualitative agreement between the two tests (Cohen's kappas (κ)=0.323 and 0.300; p=0.003 and 0.005) showing a lower rate of positives with the home test. Both used smartphones showed good quantitative and qualitative agreement. CONCLUSIONS: The tests are quantitatively not interchangeable. However, the home test may be applicable for the serial follow-up management of patients with IBD. The higher rate of samples classified as negative with the home test may lead to an underestimation of affected patients.
- Find related publications in this database (using NLM MeSH Indexing)
- Smartphone - administration & dosage
- Humans - administration & dosage
- Feces - chemistry
- Leukocyte L1 Antigen Complex - analysis
- Inflammatory Bowel Diseases - diagnosis
- Enzyme-Linked Immunosorbent Assay - methods
- Find related publications in this database (Keywords)
- home test
- smartphone
- calprotectin
- fecal