Challenges with Point-Of-Care Tests (POCT) for Celiac Disease

Abstract

Current screening test for celiac disease involves blood test in centralized pathology laboratories, typically performing enzyme-linked immune-sorbent assays (ELISA) to detect specific celiac disease antibodies. Most of the current available celiac disease antibody tests detect anti-gliadin (AGA), anti-endomysial (EMA), anti-transglutaminase (tTG), or deamidated gluten peptide (DGP) antibodies from serum or whole blood samples. It requires blood collection from untreated celiac patients, which is often invasive and inconvenient. There is a rapid growth in demand for noninvasive celiac tests for the early and fast diagnosis of celiac disease to help potential celiac patients obtain results and take corresponding actions. Over the last decade, several point-of-care tests (POCT) have been introduced to the market, but these tests have not been widely accepted by clinicians. Moreover, the 2009 NICE guideline CG 86 recommended that self-tests and/or POCT for celiac disease should not be used as a substitute for laboratory-based tests. Here, we provide a background on the evolution of POCT for celiac disease. We discuss general principle of operation for the known commercial kits as well as the use of various antigens and antibodies in different tests developed over the years. Finally, we discuss challenges for future research directions in celiac disease POCTs.

A compact SPR biosensor device for the rapid and efficient monitoring of gluten-free diet directly in human urine

“…The development of portable, compact and easy-to-handle tools entails significant advantages for its self-use by patients, as it allows direct detection or personalized monitoring of therapies usually with a small amount of a biological sample. Such is the case of the qualitative tests based on lateral flow immunochromatography (LFT) Sintomax® (Augurix SA, Switzerland), Xeliac® Test (Eurospital, Italy), and Biocard TM celiac test (AniBiotech®, Vantaa, Finland) [22][23][24][25]. These companies have developed qualitative, direct, rapid and easy tests that support the monitoring or the diagnosis of the disease by the end-user.…”