Rapid Test Detects H Pylori With High Accuracy, Sensitivity

A novel, rapid point-of-care blood test that looks for the presence of 2 specific antibodies demonstrated 93.7% accuracy in detecting Helicobacter pylori (H pylori) infection, according to a research letter published in Clinical Gastroenterology and Hepatology.  

“The test uses the flagellar filament capping protein (FliD), which is an essential element of H pylori functional flagellar assembly and exists in every H pylori strain, and the cytotoxin-associated gene A (CagA),” explained corresponding author Christian Schulz, MD, of the Ludwig Maximilian University of Munich, Germany, and coauthors.

Researchers investigated the test’s abilities among 111 patients from 2 different trials who underwent esophagogastroduodenoscopy.

With histology and culture as a reference method, the blood test demonstrated what the authors called an “unprecedented performance”: a sensitivity of 100%, a specificity of 87.9%, and an accuracy of 93.7%. The positivity rate for the FliD or CagA combination was 100% in the 53 patients with H pylori infection, according to the study. In the remaining 58 patients who were H pylori negative, the test detected 12.1% as positive for either FliD or CagA antibodies and confirmed the absence of infection in 87.9%.

“The reading of the test results is laboratory-free, rapid, and consistent, based on a colorimetric detection of the antibody response against the two selected H pylori antigens,” the authors wrote.

A panel of 5 health care professionals who rated the lateral flow tests in a blinded manner had an accuracy of 91.5% to 95.1%, sensitivity of 98.1% to 100%, and specificity of 89.1% to 94.3%, according to the research letter. The test’s optimal readout time was between 20 and 25 minutes.

“The point-of-care test offers a new opportunity in the management of patients presenting with dyspeptic symptoms in a nonspecialized outpatient setting,” the authors advised. “The high sensitivity limits the chances of an unrecognized H pylori infection and identifies patients with a positive test who require a further confirmatory test before initiating eradication therapy.”

—Jolynn Tumolo

Reference:
Schulz C, Kalali B, Link A, Gerhard M, Malfertheiner P. New rapid Helicobacter pylori blood test based on dual detection of FliD and CagA antibodies for on-site testing. Clin Gastroenterol Hepatol. 2023;21(1):229-231.e1. doi: 10.1016/j.cgh.2021.11.008