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Diagnostic accuracy of a new point-of-care screening assay for celiac disease.
World J Gastroenterol. 2013 Aug 21; 19(31):5111-7.WJ

Abstract

AIM

To determine the diagnostic accuracy of a new point-of-care assay detecting anti-deamidated gliadin peptides in celiac disease (CD) patients.

METHODS

One-hundred-and-twelve patients (age range: 1.8-79.2 years old) with clinical symptoms suggestive of CD and/or first-degree relatives (FDR) of CD patients (n = 66), and confirmed CD on a gluten-free diet (GFD) (n = 46), were prospectively enrolled in the study at Gastroenterology outpatient clinics for adult patients and from the Gastroenterology Consultation Ward at the Pediatric Department of the University Hospital of Geneva. Written informed consent was obtained from all subjects enrolled. The study received approval from the local ethics committee. The original CD diagnosis had been based on serum-positive IgA anti-tissue transglutaminase enzyme-linked immunosorbent assay (ELISA) (QuantaLite™, Inova Diagnostics, San Diego, CA, United States) and on biopsy results. Serum samples from all study participants were tested by the new CD lateral flow immunochromatographic assay (CD-LFIA) device, Simtomax® Blood Drop (Augurix SA, BioArk, Monthey, Switzerland) to detect immunoglobulin (Ig)A and IgG antibodies against deamidated gliadin peptides. The diagnostic performance was evaluated using receiver operating characteristic curves with 95%CIs. A cut-off of 2 on the Rann colorimetric scale was used to calculate the device's sensitivity and specificity.

RESULTS

CD-LFIA was highly accurate in detecting untreated celiac patients. In the group of patients with CD symptoms and/or FDR, eight new cases of CD were detected by ELISA and biopsy. All of these new cases were also correctly identified by CD-LFIA. The test yielded four false positive and four false negative results. The false positive results were all within the groups with clinical symptoms suggestive of CD and/or FDR, whereas the false negative results were all within the GFD group. The test yeld a sensitivity of 78.9% (95%CI: 54.4-93.9) and specificity of 95.7% (95%CI: 89.4-98.8), and the area under the curve reached 0.893 (95%CI: 0.798-0.988). The Kappa coefficient, calculated according to the values obtained by two readers from the same device, was of 0.96 (SE: 0.06). When the GFD patients were excluded from the analysis, the area under the curve reached 0.989 (95%CI: 0.971-1.000) and the Kappa coefficient, calculated according to the values obtained by two readers from the same device, became 0.96 (SE: 0.07). Furthermore, using the Rann scale cut-off of 2 without the GFD patients, sensitivity was 100% and specificity was 93.1% (95%CI: 83.3-98.1).

CONCLUSION

The new CD-LFIA rapid screening test shows good diagnostic accuracy, sensitivity and specificity, and may rule out CD in patients with CD-related symptoms.

Authors+Show Affiliations

Vidymed, 1007 Lausanne, Switzerland.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23964145

Citation

Benkebil, Faiza, et al. "Diagnostic Accuracy of a New Point-of-care Screening Assay for Celiac Disease." World Journal of Gastroenterology, vol. 19, no. 31, 2013, pp. 5111-7.
Benkebil F, Combescure C, Anghel SI, et al. Diagnostic accuracy of a new point-of-care screening assay for celiac disease. World J Gastroenterol. 2013;19(31):5111-7.
Benkebil, F., Combescure, C., Anghel, S. I., Besson Duvanel, C., & Schäppi, M. G. (2013). Diagnostic accuracy of a new point-of-care screening assay for celiac disease. World Journal of Gastroenterology, 19(31), 5111-7. https://doi.org/10.3748/wjg.v19.i31.5111
Benkebil F, et al. Diagnostic Accuracy of a New Point-of-care Screening Assay for Celiac Disease. World J Gastroenterol. 2013 Aug 21;19(31):5111-7. PubMed PMID: 23964145.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Diagnostic accuracy of a new point-of-care screening assay for celiac disease. AU - Benkebil,Faiza, AU - Combescure,Christophe, AU - Anghel,Silvia I, AU - Besson Duvanel,Cécile, AU - Schäppi,Michela G, PY - 2013/01/29/received PY - 2013/04/23/revised PY - 2013/05/08/accepted PY - 2013/8/22/entrez PY - 2013/8/22/pubmed PY - 2014/1/30/medline KW - Celiac disease KW - Deamidated gliadin KW - Point-of-care assay KW - Screening KW - Total immunoglobulin A SP - 5111 EP - 7 JF - World journal of gastroenterology JO - World J. Gastroenterol. VL - 19 IS - 31 N2 - AIM: To determine the diagnostic accuracy of a new point-of-care assay detecting anti-deamidated gliadin peptides in celiac disease (CD) patients. METHODS: One-hundred-and-twelve patients (age range: 1.8-79.2 years old) with clinical symptoms suggestive of CD and/or first-degree relatives (FDR) of CD patients (n = 66), and confirmed CD on a gluten-free diet (GFD) (n = 46), were prospectively enrolled in the study at Gastroenterology outpatient clinics for adult patients and from the Gastroenterology Consultation Ward at the Pediatric Department of the University Hospital of Geneva. Written informed consent was obtained from all subjects enrolled. The study received approval from the local ethics committee. The original CD diagnosis had been based on serum-positive IgA anti-tissue transglutaminase enzyme-linked immunosorbent assay (ELISA) (QuantaLite™, Inova Diagnostics, San Diego, CA, United States) and on biopsy results. Serum samples from all study participants were tested by the new CD lateral flow immunochromatographic assay (CD-LFIA) device, Simtomax® Blood Drop (Augurix SA, BioArk, Monthey, Switzerland) to detect immunoglobulin (Ig)A and IgG antibodies against deamidated gliadin peptides. The diagnostic performance was evaluated using receiver operating characteristic curves with 95%CIs. A cut-off of 2 on the Rann colorimetric scale was used to calculate the device's sensitivity and specificity. RESULTS: CD-LFIA was highly accurate in detecting untreated celiac patients. In the group of patients with CD symptoms and/or FDR, eight new cases of CD were detected by ELISA and biopsy. All of these new cases were also correctly identified by CD-LFIA. The test yielded four false positive and four false negative results. The false positive results were all within the groups with clinical symptoms suggestive of CD and/or FDR, whereas the false negative results were all within the GFD group. The test yeld a sensitivity of 78.9% (95%CI: 54.4-93.9) and specificity of 95.7% (95%CI: 89.4-98.8), and the area under the curve reached 0.893 (95%CI: 0.798-0.988). The Kappa coefficient, calculated according to the values obtained by two readers from the same device, was of 0.96 (SE: 0.06). When the GFD patients were excluded from the analysis, the area under the curve reached 0.989 (95%CI: 0.971-1.000) and the Kappa coefficient, calculated according to the values obtained by two readers from the same device, became 0.96 (SE: 0.07). Furthermore, using the Rann scale cut-off of 2 without the GFD patients, sensitivity was 100% and specificity was 93.1% (95%CI: 83.3-98.1). CONCLUSION: The new CD-LFIA rapid screening test shows good diagnostic accuracy, sensitivity and specificity, and may rule out CD in patients with CD-related symptoms. SN - 2219-2840 UR - https://www.unboundmedicine.com/medline/citation/23964145/Diagnostic_accuracy_of_a_new_point_of_care_screening_assay_for_celiac_disease_ L2 - http://www.wjgnet.com/1007-9327/full/v19/i31/5111.htm DB - PRIME DP - Unbound Medicine ER -