Briefly, the test was read as CD positive and IgAD when both the control line and the line corresponding to anti-DGP detection could be seen. Nutrition Department, and the serological testing was performed at the Lyon-Sud Hospital-Immunology Laboratory. The diagnosis of CD was based on IgG anti-tTG serology, biopsy results and patient follow-up. The serum samples were retrospectively tested on the CD-LFIA test. Results A total of eight (8) patients were diagnosed as new CD. All were correctly identified by the CD-LFIA. The test yielded four (4) false positive results. Two patients with positive IgG anti-tTG were negative on CD-LFIA, but were classified as CD negative based on biopsy results and patient follow-up. The remaining 33 patients were found negative by both methods. The specificity and sensitivity of CD-LFIA was of 89.2% [74.6-97.0] and of 100% [63.1-100] respectively. The negative predictive value (NPV) was of 100% [89.4-100], and the Likelihood Ratio for Negative Test (LR-) was of 0 [0.0-0.91]. Conclusions CD-LFIA is a useful, non-invasive and rapid tool to rule out CD in primary care paediatric patients having CD-related symptoms and IgAD. Patients having a positive CD-LFIA result could be then readily directed to secondary care setting for further evaluation by standard serology and biopsy. strong class=”kwd-title” Keywords: Celiac disease, IgA deficiency, Deamidated gliadin peptides, Point-of-care test Background Selective IgA deficiency (IgAD) is a common immunodeficiency occurring in Caucasians with a prevalence rising up to 1 1:600 [1, 2]. IgAD is characterized by total IgA serum levels below 0.06?g/L and normal levels of IgM and IgG [3]. Although the majority of IgAD individuals are Rabbit Polyclonal to RHO asymptomatic, IgAD is associated with autoimmune disorders such as celiac disease (CD) [4]. Its CTP354 frequency is raised and estimated to be about 1:40 among patients suffering from CD [5C7]. The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) strongly recommends testing for the presence of IgA autoantibodies against tissue transglutaminase (tTG) as the initial step for CD diagnosis [5, 8, 9]. Moreover, in cases where the total IgA status is unknown, the guidelines strongly recommend IgA measurement [8C10]. In case of IgAD, a positive IgG anti-Endomysium (EMA) [8], anti- tTG or anti- deamidated gliadin peptides (DGP) antibodies is considered as diagnostically relevant [8C10]. Unfortunately, investigation of the total IgA levels is frequently neglected, and patients suffering from IgAD are often not aware of their IgA deficiency CTP354 and may therefore be tested as CD negative, delaying considerably the diagnosis [3, 11]. Recently, it has been CTP354 demonstrated that the detection of IgG against DGP has a high specificity and a better sensitivity than IgG anti-tTG [12C16]. Therefore, their use was suggested as an alternative for the diagnosis of CD in IgAD patients [3]. A multi-analytic lateral-flow immunochromatographic assay (CD-LFIA) based on the rapid detection of both IgA and IgG anti-DGP and total IgA has previously been shown to have a good diagnostic accuracy to rule out CD in high-risk paediatric and adult populations [17, 18]. The aim of the present study was to evaluate its use as a tool to rule out CD in children suffering from IgAD. Methods Patients Paediatric patients suspected of CD or having high CD risk factors were referred from outpatient clinics located in the area of Rhone-Alpes (France) to the Hospices Civils de Lyon, Paediatric Hospital-Gastroenterology-Hepatology- Nutrition Department for further CD investigations. The CD investigations, including the sample collection, were performed within the Paediatric Hospital-Gastroenterology-Hepatology- Nutrition Department, and the serological testing was performed at the Lyon-Sud Hospital-Immunology Laboratory. CTP354 From 2001 to 2012, 45 paediatric patients were selectively diagnosed with IgAD with total IgA levels below 0.06?g/L. The study stems from collaboration between the.