Abstract
Objetivo
Evaluar prospectivamente la validez de un método diagnóstico de serología «rápida» (a partir de sangre capilar) en nuestro medio, tomando como referencia una combinación de métodos diagnósticos estándar.
Diseño
Prospectivo. El endoscopista, el patólogo y las personas responsables de la lectura del test rápido de la ureasa, la prueba del aliento y la serología «rápida» desconocían el resultado de los demás métodos diagnósticos.
Emplazamiento
Servicio de Gastroenterología de un hospital terciario.
Participantes
Treinta pacientes consecutivos con síntomas atribuibles al tracto digestivo superior y a quienes se realizó una gastroscopia oral.
Mediciones principales
Se obtuvieron biopsias gástricas para estudio histológico y test rápido de ureasa, y se realizó una prueba del aliento con 13C-urea. Para la serología «rápida» se utilizó el kit comercial SureStep™ HP WB test. Se consideró a un paciente infectado cuando al menos dos de las tres técnicas validadas (test rápido de ureasa, histología, prueba del aliento) eran positivas, y no infectado cuando todas eran negativas.
Resultados
Se incluyó a 30 pacientes, un 30% varones, con una edad media de 51 años. La prevalencia de infección según el patrón de referencia fue del 61%, siendo dos casos clasificados como indeterminados. La serología «rápida» fue positiva en 8 pacientes y negativa en 22. La sensibilidad, especificidad, valor predictivo positivo y valor predictivo negativo fueron, respectivamente, del 41% (intervalo de confianza [IC] del 95%, 18–65), el 91% (74–100), el 87% (65–100) y el 50% (28–72). El cociente de probabilidades positivo fue de 4,5 y el negativo de 0,65.
Conclusiones
La serología «rápida» utilizada en el presente estudio posee una deficiente exactitud diagnóstica y, por tanto, no debería emplearse en la práctica clínica para identificar la infección por Helicobacter pylori.
Palabras clave: Diagnóstico, Helicobacter pylori, Prueba del aliento, Serología
Abstract
Objective
To evaluate prospectively the validity of a «rapid» serology diagnosis method (using capillary blood) in our ambit, taking for reference a combination of standard diagnostic methods.
Design
Prospective. The endoscopist, pathologist and those responsible for interpreting the rapid urease test, the breath test and «rapid» serology did not know the results of the other diagnostic methods.
Setting
Gastro-enterology service of a tertiary hospital.
Participants
30 consecutive patients with symptoms attributable to the upper digestive tract and who underwent an oral gastroscopy.
Main measurements
Gastric biopsies for histology examination and for the rapid urease test and a breath test with 13C-urea were conducted. For «rapid» serology, the commercial SureStep™ HP WB test kit was used. A patient was considered infected when at least two of the three validated techniques (rapid urease test, histology, breath test) were positive; and not infected, when all three were negative.
Results
30 patients, 30% male, with a mean age of 51, were included. The reference standard indicated 61% prevalence of infection, with two cases classed as undetermined. «Rapid» serology was positive in 8 patients and negative in 22. Sensitivity, specificity, positive predictive value and negative predictive value were, respectively, 41% (95% CI, 18–65), 91% (74–100), 87% (65–100) and 50% (28–72). The positive probability quotient was 4.5; and the negative, 0.65.
Conclusion
The «rapid» serology used in the current study has deficient diagnostic accuracy. Therefore, it should not be used in clinical practice to identify H. pylori infection.
Key words: Diagnosis, Helicobacter pylori, Breath test, Serology
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