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Accuracy of the Ultra-Rapid Urease Test for diagnosis of Helicobacter pylori infection
Exactitud del test Ultra-Rapido de la Ureasa para el Diagnóstico de la infección por Helicobacter pylori
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Adrian Gerald McNicholla,b,
Corresponding author
adrian.mcn@gmail.com

Corresponding author.
, Julio Duconsc, Jesús Barriod, Luis Bujandab,e, Montserrat Forné-Barderaf, Reyes Aparcerog, Julio Ponceb,h, Robin Riverai, José María Dedeu-Cusoj, Pilar Garcia-Iglesiasb,k, Miguel Montorol, Alicia Bejeranoa, Yolanda Ber-Nietoc, Belen Madrigald, Eva Zapatab,e, Carmen Loras-Alastrueyf, Manuel Castrog, Andrea Nevarezh, Isabel Mendezi, Felipe Bory-Rosj..., Mireia Miquel-Planasb,k, Isabel Veral, Olga P. Nyssena,b, Javier P. Gisberta,b, on behalf of the Helicobacter pylori Study Group of the Asociación Española de Gastroenterología (AEG) Ver más
a Gastroenterology Unit, Hospital Universitario de La Princesa and Instituto de Investigación Sanitaria Princesa (IIS-IP), Madrid, Spain
b Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain
c Hospital Lozano Blesa, Zaragoza, Spain
d Hospital Río Hortega, Valladolid, Spain
e Hospital de Donostia, San Sebastián, Spain
f Mutua de Terrassa, Barcelona, Spain
g Hospital de Valme, Sevilla, Spain
h Hospital La Fe, Valencia, Spain
i Hospital Costa del Sol, Málaga, Spain
j Hospital del Mar, Barcelona, Spain
k Hospital de Sabadell, Barcelona, Spain
l Hospital San Jorge, Huesca, Spain
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Received 23 March 2017. Accepted 25 July 2017
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Tables (5)
Table 1. CrossTable of Rapid Urease Tests (by commercial brand) vs. histology in the diagnosis of H. pylori infection.
Table 2. CrossTable of Ultra Rapid Urease Test (URUT) (by time of assessment) vs. histology in the diagnosis of Helicobacter pylori infection.
Table 3. CrossTable of Rapid and Ultra Rapid Urease Tests (RUT and URUT) vs. histology in the diagnosis of Helicobacter pylori infection in patients not taking proton pump inhibitor treatment.
Table 4. Rapid and Ultra Rapid Urease Test's (RUT and URUT) accuracy for the diagnosis of Helicobacter pylori infection in all subanalyses.
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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 24h to give results. The new Ultra-Rapid Urease Test (URUT) kit by Biohit® requires less than 1h.

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 1min, 5min, 30min and 60min and the RUT was checked over the course of 24h. 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 6h. 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:
Helicobacter pylori
Urease
Gastroscopy
Diagnosis
Resumen
Introducción

El test de la ureasa (TRU) es un método simple, barato y relativamente rápido para el diagnóstico de la infección por Helicobacter pylori (H. pylori). Por tanto, es el método de elección en pacientes sometidos a gastroscopia. La mayoría de los kits requieren 24 h para obtener un resultado. En nuevo test ultrarrápido de la ureasa (TURU) de Biohit requiere menos de una hora.

Objetivo

Determinar la exactitud diagnóstica del TURU.

Método

Estudio multicéntrico, prospectivo y ciego, en el que se incluyó a pacientes dispépticos. Se obtuvieron 3 biopsias de antro y una de corpus durante la gastroscopia para análisis histológico estándar, TRU y TURU. El resultado del TURU se comprobó a los 1, 5, 30 y 60 min, mientras que el TRU se evaluó a lo largo de 24 h. La histología se utilizó como patrón oro.

Resultados

Se incluyó a 144 pacientes, 68% mujeres, edad media 49 años, el 50% fueron positivos para H. pylori. TRU y TURU diagnosticaron correctamente el 85,9% y 90,0% de los casos, respectivamente. La duración media de espera para un resultado positivo del TRU fue 6 h. La sensibilidad, la especificidad y los valores predictivos negativo y positivo para el TRU fueron, respectivamente, del 82, el 90, el 89 y el 84%. Los resultados del TURU fueron equivalentes (el 85, el 94, el 94 y el 87%). Estos resultados mejoraron al excluir los pacientes que tomaban IBP (TRU: 86, 91, 93 y 83%; TURU: 91, 94, 96 y 89%). La comparación de distribución de diagnósticos correctos entre TRU y TURU no encontró diferencias estadísticamente significativas (test de McNemar p=0,3) pero existe una tendencia a mejores resultados con el TURU.

Conclusión

El TURU es equivalente (o algo superior) al TRU tradicional en el diagnóstico de la infección por H. pylori y obtiene los resultados en menos de una hora.

Palabras clave:
Helicobacter pylori
Ureasa
Gastroscopia
Diagnóstico

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