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

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(R) 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. pyloripositive. 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. pyloriinfection, and provides results in less than an hour (AU)

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 (AU)

Accuracy of the Ultra-Rapid Urease Test for diagnosis of Helicobacter pylori infection.

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.

Second-line rescue triple therapy with levofloxacin after failure of non-bismuth quadruple "sequential" or "concomitant" treatment to eradicate H. pylori infection.

BACKGROUND: Non-bismuth quadruple "sequential" and "concomitant" regimens, including a proton pump inhibitor (PPI), amoxicillin, clarithromycin and a nitroimidazole, are increasingly used as first-line treatments for Helicobacter pylori infection. Eradication with rescue regimens may be challenging after failure of key antibiotics such as clarithromycin and nitroimidazoles. AIM: To evaluate the efficacy and tolerability of a second-line levofloxacin-containing triple regimen (PPI-amoxicillin-levofloxacin) in the eradication of H. pylori after non-bismuth quadruple-containing treatment failure. DESIGN: prospective multicenter study. PATIENTS: in whom a non-bismuth quadruple regimen, administered either sequentially (PPI + amoxicillin for 5 days followed by PPI + clarithromycin + metronidazole for 5 more days) or concomitantly (PPI + amoxicillin + clarithromycin + metronidazole for 10 days) had previously failed. INTERVENTION: levofloxacin (500 mg b.i.d.), amoxicillin (1 g b.i.d.) and PPI (standard dose b.i.d.) for 10 days. OUTCOME: eradication was confirmed with (13)C-urea breath test 4-8 weeks after therapy. Compliance and tolerance: compliance was determined through questioning and recovery of empty medication envelopes. Incidence of adverse effects was evaluated by means of a questionnaire. RESULTS: 100 consecutive patients were included (mean age 50 years, 62% females, 12% peptic ulcer and 88% dyspepsia): 37 after "sequential", and 63 after "concomitant" treatment failure. All patients took all medications correctly. Overall, per-protocol and intention-to-treat H. pylori eradication rates were 75.5% (95% CI 66-85%) and 74% (65-83%). Respective intention-to-treat cure rates for "sequential" and "concomitant" failure regimens were 74.4% and 71.4%, respectively. Adverse effects were reported in six (6%) patients; all of them were mild. CONCLUSION: Ten-day levofloxacin-containing triple therapy constitutes an encouraging second-line strategy in patients with previous non-bismuth quadruple "sequential" or "concomitant" treatment failure.