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%
Humans , Male , Female , Middle Aged , Antigens, Viral/analysis , Helicobacter pylori/isolation & purification , Helicobacter Infections/diagnosis , Feces/chemistry , Helicobacter pylori/immunology , Enzyme-Linked Immunosorbent Assay , Breath Tests , ROC Curve , Sensitivity and Specificity , Prospective Studies
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.
Antigens, Bacterial/analysis , Feces/microbiology , Helicobacter Infections/diagnosis , Helicobacter pylori/immunology , Immunoassay/methods , Immunoenzyme Techniques/methods , Reagent Kits, Diagnostic , Aged , Area Under Curve , Breath Tests , Dyspepsia/microbiology , Feces/chemistry , Female , Helicobacter pylori/isolation & purification , Humans , Male , Middle Aged , Observer Variation , Peptic Ulcer/microbiology , Prospective Studies , ROC Curve , Reproducibility of Results , Sensitivity and Specificity
BACKGROUND: The eradication of Helicobacter pylori (HP) using clarithromycin (CLA)-based triple therapy depends on the resistance of HP to antibiotics. The Maastricht III conference recommends the implementation of locoregional surveillance programmes for primary resistance of HP to CLA. In Andalusia, there are no previous data in this respect. The aim of this study was to determine the prevalence of the primary resistance of HP to CLA and levofloxacin (LF) in southern Spain. METHODS: Multicentre cross sectional study was carried out in 6 hospitals in Andalusia. Patients of both sexes numbering 401 were included (male 48%), aged 18-80 years and naïve to HP eradication. Resistance of HP to CLA (CLAr) and LF (LFr) was assessed by determining mutations by PCR: mutations of the 23S rRNA gene define CLAr and mutations of the gene gyrA define LFr. Four hundred one gastric samples were collected. CLAr was detected in 72 patients (17.9%) and LFr was detected in 56 patients (13.9%). Heteroresistance was detected for both antibiotics: CLA 37/72 (51.3%) and LF 28/56 (50%). Variability for CLAr was detected among the centres, ranging from 11.5% to 24.7% without statistical significance (p = 0.12). Female sex was related to CLAr. CONCLUSIONS: In Andalusia, there is a high rate of primary CLAr and LFr. CLA-based triple therapy should be avoided as the primary eradication regimen in this region. There is a wide variability in the rate of CLAr among centres.
Anti-Bacterial Agents/pharmacology , Clarithromycin/pharmacology , Disease Eradication , Drug Resistance, Multiple, Bacterial/genetics , Helicobacter Infections/drug therapy , Helicobacter pylori/drug effects , Levofloxacin/pharmacology , Adolescent , Adult , Aged , Aged, 80 and over , Anti-Bacterial Agents/therapeutic use , Clarithromycin/therapeutic use , Cross-Sectional Studies , Female , Helicobacter Infections/epidemiology , Helicobacter Infections/microbiology , Helicobacter pylori/genetics , Humans , Levofloxacin/therapeutic use , Male , Microbial Sensitivity Tests , Middle Aged , Mutation , Polymerase Chain Reaction , Prevalence , RNA, Bacterial/genetics , RNA, Ribosomal, 23S/genetics , Spain/epidemiology , Young Adult
