Acceso usuarios
, Fernando Salcedo Aguilar, Isabel Sanfeliu Santa Olalla, Antonia Montserrat Torres, Enric Brullet Benedit, Jordi Real Gatius, Rafael Campo Fernández de los Ríos, Antonio Navarro
Fundamento: El objetivo del presente estudio fue evaluar la fiabilidad diagnóstica y reproducibilidad de una nueva prueba rápida inmunocromatográfica (Stick H. pyl, Operon SA, Zaragoza), que utiliza anticuerpos monoclonales para la detección de antígeno de Helicobacter pylori en heces, y compararla con la prueba actualmente comercializada (HpSA, EIA, Premier Platinum HpSA, Meridian Diagnosis Inc, Cincinnati, Ohio). Método: Se incluyó a 71 pacientes sometidos a endoscopia para estudio de síntomas dispépticos. Se practicaron biopsias para CLO-test e histología antral. Se consideró infectados por Helicobacter pylori a aquellos pacientes que presentaban histología y CLO-test positivos, y no infectados a aquellos con ambos tests negativos. En heces se realizaron 2 determinaciones seriadas de antígeno de Helicobacter pylori mediante HpSA y 4 determinaciones consecutivas con Stick H. pyl. Se calcularon la sensibilidad, la especificidad y los valores predictivos positivo y negativo. La concordancia entre determinaciones se evaluó mediante el estadístico kappa. Resultados: De los 68 pacientes evaluables, 48 presentaban infección por Helicobacter pylori. La sensibilidad, la especificidad y los valores predictivos positivo y negativo en las distintas determinaciones oscilaron entre 89-96%, 60-70%, 85-88% y 74-87% respectivamente para Stick H. pyl frente al 70-75%, 60-85%, 85-92% y 55-80% para HpSA. Los índices de concordancia variaron entre 0,82 y 0,93 para Stick H. pyl frente a 0,57 para HpSA. Conclusiones: Stick H. pyl en heces presenta excelentes sensibilidad y reproducibilidad para el diagnóstico de la infección por Helicobacter pylori. Su fiabilidad es superior a la de HpSA.
Background: To date, the search for an in-office reliable test for Helicobacter pylori infection has been unsuccessful. The aim of the present study was to evaluate a new immunocromatographic in-office test using monoclonal antibodies to determine the presence of Helicobacter pylori antigen in faeces (Stick H. pyl, Operon S.A. Zaragoza). We compared its reliability and reproducibility to the currently available test (HpSA, EIA, Premier Platinum HpSA, Meridian Diagnosis Inc, Cincinnati, Ohio). Patients and method: 71 consecutive dyspeptic patients were enrolled. Helicobacter pylori status was determined by rapid urease test and Giemsa stain of antral biopsy. Patients with a positive result in the two tests were considered as infected and those with a negative result in both tests were regarded as not infected. Faecal Helicobacter pylori antigen was tested twice by means of HpSA. Four consecutive determinations of Stick H. pyl were also performed. We calculated sensitivity, specificity and positive and negative predictive values of each determination. Concordance between determinations was estimated by the kappa statistics. Results: Forty-eight of 68 patients were infected by Helicobacter pylori. Sensitivity, specificity and positive and negative predictive values were 89-96%, 60-70% 85-88% and 74-87%, respectively, for Stick H. pyl and 70-75%, 60-85%, 85-92% and 55-80%, respectively, for HpSA. Correlation coefficients were 0.82-0.93 for Stick H. pyl and 0.57 for HpSA. Conclusions: The new Stick H. pyl test shows excellent sensitivity and reproducibility for diagnosis of H. pylori infection. Its reliability appears to be far better than that of HpSA.
