Prospective, study comparing the accuracy of two different stool antigen tests (Premier Platinum HpSA and novel ImmunoCard STAT! rapid test) for the diagnosis of Helicobacter pylori infection.

BACKGROUND: At present only monoclonal EIA (enzyme-immunoassay) stool antigen-tests have obtained optimal accuracy in the diagnosis of Helicobacter pylori. Our aim was to evaluate the accuracy of two stool antigen-tests, the validated Premier Platinum HpSA PLUS (EIA test) and the newly available ImmunoCard STAT! HpSA HD (rapid test) for the initial diagnosis and the confirmation of eradication of H. pylori infection. PATIENTS AND METHODS: Patients with indication of H. pylori diagnosis, or confirmation after treatment were included. Data were coded to protect personal data and ensure blindness between tests. Accuracy was considered as coincident diagnosis with the gold standard (13C-urea breath test, UBT). The EIA was used as a bench standard. All stool tests were performed in duplicate. RESULTS: 264 patients completed the protocol (100 naïve, 164 post-eradication). Average age was 52 years, 61% women, 11% ulcer. Positive diagnoses by UBT were 41% for naïve and 17% for post-eradication. Overall ImmunoCard and EIA accuracies were respectively 91% (95%C.I.=88-94%) and 89% (86-93%), sensitivities 72% (67-78%) and 72% (67-78%), and specificities 98% (96-100%), and 95% (92-97%). Concordance between ImmunoCard and EIA was 95% (93-98%). DISCUSSION: Our results indicate that the newly available ImmunoCard rapid stool antigen-test achieves 90% accuracy, with high specificity but suboptimal sensitivity. The ImmunoCard attained equivalent accuracies as the EIA bench standard, with 95% concordance.

Prospective, study comparing the accuracy of two different stool antigen tests (Premier Platinum HpSA and novel ImmunoCard STAT rapid test) for the diagnosis of Helicobacter pylori infection / Estudio prospectivo y comparativo entre la exactitud de 2 pruebas de antígenos en heces (Premier Platinum HpSA® y el nuevo test rápido ImmunoCard® STAT) para el diagnóstico de la infección por Helicobacter pylori

BACKGROUND: At present only monoclonal EIA (enzyme-immunoassay) stool antigen-tests have obtained optimal accuracy in the diagnosis of Helicobacter pylori. Our aim was to evaluate the accuracy of two stool antigen-tests, the validated Premier Platinum HpSA PLUS (EIA test) and the newly available ImmunoCard STAT! HpSA HD (rapid test) for the initial diagnosis and the confirmation of eradication of H. pylori infection. PATIENTS AND METHODS: Patients with indication of H. pylori diagnosis, or confirmation after treatment were included. Data were coded to protect personal data and ensure blindness between tests. Accuracy was considered as coincident diagnosis with the gold standard (13C-urea breath test, UBT). The EIA was used as a bench standard. All stool tests were performed in duplicate. RESULTS: 264 patients completed the protocol (100 naïve, 164 post-eradication). Average age was 52 years, 61% women, 11% ulcer. Positive diagnoses by UBT were 41% for naïve and 17% for post-eradication. Overall ImmunoCard and EIA accuracies were respectively 91% (95%C. I. =88-94%) and 89% (86-93%), sensitivities 72% (67-78%) and 72% (67-78%), and specificities 98% (96-100%), and 95% (92-97%). Concordance between ImmunoCard and EIA was 95% (93-98%). DISCUSSION: Our results indicate that the newly available ImmunoCard rapid stool antigen-test achieves 90% accuracy, with high specificity but suboptimal sensitivity. The ImmunoCard attained equivalent accuracies as the EIA bench standard, with 95% concordance

ANTECEDENTES: En la actualidad, únicamente los métodos de detección de antígenos en heces monoclonales basados en enzimoinmunoanálisis (ELISA) han obtenido una adecuada precisión para el diagnóstico de la infección por Helicobacter pylori. Nuestro objetivo fue evaluar la exactitud (sensibilidad y especificidad) de 2 métodos de antígenos en las heces, el previamente validado Premier Platinum HpSA® PLUS (ELISA) y el nuevo ImmunoCard® STAT! HpSA® HD (test rápido), para el diagnóstico inicial y la confirmación de la erradicación de la infección por H. pylori. PACIENTES Y MÉTODOS: Se incluyeron pacientes en los que estaba indicado el diagnóstico inicial de la infección por H. pylori o su confirmación tras el tratamiento. Los datos fueron codificados y los evaluadores de ambos test fueron ciegos para los resultados de las pruebas diagnósticas. El resultado principal fue la coincidencia con el resultado del patrón oro (prueba del aliento con 13C-urea). Los test en heces se realizaron por duplicado. RESULTADOS: Doscientos sesenta y cuatro pacientes completaron el protocolo (100 naïve, 164 posterradicación). La edad media fue de 52 años, el 61% fueron mujeres y el 11% tenían úlcera péptica. La prueba del aliento fue positiva en el 41% de los pacientes naïve y en el 17% posterradicación. La exactitud global del método rápido y del ELISA fue, respectivamente, 91% (IC 95%: 88-94%) y 89% (86-93%), la sensibilidad 72% (67-78%) y 72% (67-78%), y la especificidad 98% (96-100%) y 95% (92-97%). La concordancia entre el método ImmunoCard® y ELISA fue del 95% (93-98%). DISCUSIÓN: El nuevo método rápido de antígenos en heces (ImmunoCard® STAT! HpSA® HD) tiene una exactitud diagnóstica del 90%, con una elevada especificidad, pero una sensibilidad insuficiente. El método ImmunoCard® tiene una exactitud equivalente al método ELISA estándar, con una concordancia del 95%