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Rapid Immunochromatography on Fresh Intestinal Biopsy Is Highly Accurate in Detecting Intestinal Antitransglutaminase
Sara Lega1, Luigina De Leo1, Fabiana Ziberna1
1Institute for Maternal and Child Health, I.R.C.C.S. "Burlo Garofolo," Trieste, Italy.
Insights
A new Rapid_AntiTG2 test accurately detects intestinal antitransglutaminase antibodies (I-anti-TG2) in intestinal biopsies. This rapid assay shows high diagnostic accuracy for celiac disease (CeD) and excellent agreement with existing methods.
Area of Science:
- Gastroenterology
- Immunology
- Diagnostic Medicine
Background:
- Intestinal antitransglutaminase antibodies (I-anti-TG2) are specific markers for celiac disease (CeD).
- Accurate and rapid detection of I-anti-TG2 is crucial for timely CeD diagnosis.
Purpose of the Study:
- To evaluate the diagnostic accuracy of a novel immunochromatographic assay, Rapid_AntiTG2, for detecting I-anti-TG2 in intestinal biopsy lysates.
- To assess the agreement of Rapid_AntiTG2 with established methods for CeD diagnosis.
Main Methods:
- A novel immunochromatographic assay (Rapid_AntiTG2) was developed to detect I-anti-TG2 on intestinal biopsy lysates.
- Biopsies from pediatric patients were analyzed using standard histology, endomysium antibody (EMA) biopsy, and Rapid_AntiTG2.
- Diagnostic accuracy was compared to the gold standard (serology + histopathology).
Main Results:
- Rapid_AntiTG2 demonstrated very high diagnostic accuracy (sensitivity 100%, specificity 97%) in distinguishing CeD patients from controls.
- The assay showed almost perfect agreement (99% agreement, Cohen K 0.97) with the EMA biopsy reference test.
- Diagnostic accuracy remained high for potential and seronegative CeD cases.
Conclusions:
- I-anti-TG2 can be rapidly and accurately detected using an immunochromatographic assay on mechanically lysed intestinal biopsies.
- The Rapid_AntiTG2 test is quick, easy to perform, and has high diagnostic accuracy, making it suitable for endoscopy units.
- This assay can aid clinicians in diagnosing difficult-to-classify suspected CeD cases.
Introduction:
Intestinal antitransglutaminase antibodies (I-anti-TG2) are a specific marker of celiac disease (CeD). The aim of this study was to evaluate the diagnostic accuracy of a novel application of an immunochromatographic assay referred to as Rapid_AntiTG2 to detect I-anti-TG2 on intestinal biopsy lysate.
Methods:
Consecutive pediatric patients referred to a single center for elective upper endoscopy were enrolled. Biopsies were taken from duodenal bulb and distal duodenum. For each sampling site, 2 biopsies were analyzed for standard histology, 1 biopsy was cultured to perform the reference standard assay for I-anti-TG2 detection (endomysium [EMA] biopsy), and 1 biopsy was mechanically lysed to perform Rapid_AntiTG2. The primary outcome was the diagnostic accuracy of Rapid_AntiTG2 on biopsy lysate compared with that of the gold standard (serology + histopathology) for CeD diagnosis. The secondary outcome was the agreement of Rapid_AntiTG2 with EMA biopsy.
Results:
One hundred forty-eight patients were included. Of them, 79 were those with CeD (64 classical CeD, 2 seronegative CeD, and 13 potential CeD) and 69 were controls. Rapid_AntiTG2 on biopsy lysate had very high diagnostic accuracy (sensitivity 100%, specificity 97%, LR+ 34.1, LR- 0.01) in separating patients with CeD from controls. Diagnostic accuracy was unchanged in patients with potential and seronegative CeD. Rapid_AntiTG2 on biopsy lysate had almost perfect agreement with the EMA biopsy reference test (99% agreement, Cohen K 0.97).
Discussion:
I-anti-TG2 can be detected with an immunochromatographic assay after simple mechanical lysis of fresh intestinal biopsy with very high diagnostic accuracy. The test is quick and easy to perform and can be widely available in any endoscopy unit. Its implementation would allow a better understanding of the prognostic value of I-anti-TG2 and help clinicians in cases of suspected CeD that are difficult to classify.

