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Accuracy of the Ultra-Rapid Urease Test for diagnosis of Helicobacter pylori infection
Authors:Adrian Gerald McNicholl  Julio Ducons  Jesús Barrio  Luis Bujanda  Montserrat Forné-Bardera  Reyes Aparcero  Julio Ponce  Robin Rivera  José María Dedeu-Cuso  Pilar Garcia-Iglesias  Miguel Montoro  Alicia Bejerano  Yolanda Ber-Nieto  Belen Madrigal  Eva Zapata  Carmen Loras-Alastruey  Manuel Castro  Andrea Nevarez  Javier P. Gisbert
Affiliation:1. Gastroenterology Unit, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain;2. Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain;3. Hospital Lozano Blesa, Zaragoza, Spain;4. Hospital Río Hortega, Valladolid, Spain;5. Hospital de Donostia, San Sebastián, Spain;6. Mutua de Terrassa, Barcelona, Spain;7. Hospital de Valme, Sevilla, Spain;8. Hospital La Fe, Valencia, Spain;9. Hospital Costa del Sol, Málaga, Spain;10. Hospital del Mar, Barcelona, Spain;11. Hospital de Sabadell, Barcelona, Spain;12. Hospital San Jorge, Huesca, Spain
Abstract:

Background

Rapid Urease Test (RUT) is a simple, cheap and relatively fast method for diagnosing Helicobacter pylori infection. It is therefore the preferred method used for patients undergoing gastroscopy. Most kits require 24 h to give results. The new Ultra-Rapid Urease Test (URUT) kit by Biohit® requires less than 1 h.

Objective

To determine URUT's diagnostic accuracy.

Method

Prospective, blind, multi-centre study involving dyspeptic patients. One corpus biopsy and three antral biopsies were obtained during gastroscopy for standard histological analysis, RUT and URUT. The URUT result was checked after 1 min, 5 min, 30 min and 60 min and the RUT was checked over the course of 24 h. Histology was used as the gold standard test.

Results

144 patients were included, 68% female, with a mean age of 49 years old; 50% were H. pylori positive. RUT and URUT diagnoses were correct in 85.9% and 90% of the cases, respectively. The mean waiting time for a positive RUT result was 6 h. The sensitivity, specificity, and positive and negative predictive values for RUT were, respectively, 82%, 90%, 89% and 84%. The URUT's results were similar (85%, 94%, 94% and 87%). These figures improved when patients taking PPIs were excluded (RUT: 86%, 91%, 93% and 83%; URUT: 91%, 94%, 96% and 89%). No statistically significant differences were found when comparing RUT and URUT distributions of correct diagnoses (McNemar's Test, p = 0.3) but there was a tendency towards better results with the URUT.

Conclusion

The URUT is equivalent to (or slightly better than) the traditional RUT in diagnosing H. pylori infection, and provides results in less than an hour.
Keywords:Urease  Gastroscopy  Diagnosis  Ureasa  Gastroscopia  Diagnóstico
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