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EndoFaster enables real-time H. pylori diagnosis during endoscopy
EndoFaster, a novel device that performs automatic, real-time measurement of ammonium in gastric juice, accurately detected Helicobacter pylori during endoscopy in a prospective study conducted at two endoscopy units in Italy. This led researchers to conclude that the device may help identify patients for whom routine gastric biopsy can be avoided.
The EndoFaster device (NISO Biomed) “is interposed between the endoscope and the suction system, utilizing 4 mL of the gastric juice aspirated at the beginning of endoscopy,” the researchers wrote. “H. pylori diagnosis is based on the determination of ammonium concentration, as a consequence of the urease activity of the bacterium within 30-90 seconds.”
To validate preliminary data showing the device detected H. pylori on gastric mucosa with 96.7% sensitivity and 94.3% specificity, “with an accuracy equal to that of 13C-urea breath test (UBT),” the researchers used the device on 189 consecutive patients undergoing upper endoscopy (110 women; mean age, 55.7 years; 185 with non-ulcer dyspepsia).
A positive test was defined as an ammonium concentration greater than 62 ppm/mL. Accuracy was measured using histology as the gold standard, and UBT when EndoFaster and histology results conflicted.
There was an insufficient amount of aspirated gastric juice to perform the test in 3.4% of patients. Among the remaining patients, EndoFaster performed with 87.4% accuracy, 90.3% sensitivity, 85.5% specificity, 80.2% positive predictive value and 93.1% negative predictive value. Adjusted analysis accounting for reclassified H. pylori status based on UBT results (4/17 patients) showed EndoFaster performed with 92.6% accuracy, 97.1% sensitivity, 89.7% specificity, 85.9% positive predictive value and 98% negative predictive value.
“In conclusion, this large study established the high accuracy of EndoFaster in detecting H. pylori infection,” the researchers wrote. “Such a tool could be useful to select those patients in whom gastric biopsies are probably useless.” – by Adam Leitenberger
Disclosures: The researchers report no relevant financial disclosures.