A new kit to detect Campylobacter species in stool specimens: the Orion GenRead Campylobacter®

Area of Science:

• Microbiology
• Infectious Diseases
• Molecular Diagnostics

Background:

• Campylobacter enteritis is a leading cause of bacterial gastroenteritis, particularly in children.
• Current diagnostic methods, primarily culture-based, often lack sensitivity and yield delayed results.
• Rapid and accurate diagnosis is crucial for effective patient management and public health surveillance.

Purpose of the Study:

• To evaluate a novel PCR-derived method (Orion GenRead Campylobacter) for diagnosing Campylobacter enteritis.
• To compare the performance of the new method against a composite reference standard.
• To assess the utility of the Orion GenRead Campylobacter as a potential screening tool.

Main Methods:

• A prospective study included 150 patients with enteric symptoms during the 2016 summer season.
• Stool specimens were analyzed using standard culture, ELISA, in-house real-time PCR, and the Orion GenRead Campylobacter assay.
• A composite reference standard (culture positive, or culture negative with positive ELISA and real-time PCR) defined Campylobacter cases.

Main Results:

• Twenty-nine cases of Campylobacter enteritis were identified by the composite reference standard (29.7% in children, 11.6% in adults).
• Culture alone missed six positive cases.
• The Orion GenRead Campylobacter method demonstrated 100% sensitivity and 90.1% specificity, correctly identifying all positive cases and 12 false positives.

Conclusions:

• The Orion GenRead Campylobacter assay offers high sensitivity for detecting Campylobacter enteritis.
• The method's performance suggests its suitability as an effective screening tool for Campylobacter infections.
• This new PCR-based approach can overcome the limitations of traditional culture methods, enabling faster diagnosis.