Multicenter evaluation of Verigene Enteric Pathogens Nucleic Acid Test for detection of gastrointestinal pathogens

Abstract

We investigated the efficiency of the Verigene Enteric Pathogens Nucleic Acid Test (Verigene EP test), which is an automated microarray-based assay system that enables rapid and simultaneous genetic detection of gastrointestinal pathogens and toxins, including those in the Campylobacter Group, Salmonella species, Shigella species, the Vibrio Group, Yersinia enterocolitica, Shiga toxin 1 and 2, norovirus GI/GII, and rotavirus A. Three clinical laboratories evaluated the Verigene EP test, using 268 stool samples for bacterial and toxin genes and 167 samples for viral genes. Culture-based reference methods were used for the detection of bacteria and toxins, while a different molecular assay was used for viral detection. The overall concordance rate between the Verigene EP test and the reference methods for the 1940 assays was 99.0%. The overall sensitivity and specificity of the Verigene EP test were 97.0% and 99.3%, respectively. Of the 19 samples with discordant results, 13 samples were false positives and six were false negatives. The Verigene EP test simultaneously detected two targets in 11 samples; overall, the test demonstrated high efficiency in detecting crucial diarrheagenic pathogens, indicating its suitability for clinical practice.

Diagnostic performance of microscopic stool examination in Campylobacter infection performed by different medical specialties

“…Several multiplex molecular assays have been developed and used in clinical settings for other types of POCT. These systems can detect multiple pathogens with high sensitivity 16,17 and are beneficial for vulnerable individuals, such as hospitalized or immunocompromised patients. 18 Appropriate use of each type of POCT is crucial, in different clinical settings.…”

“…Nevertheless, our study indicated that microscopic examinations by physicians could not reliably rule out Campylobacter infection. Antigen testing showed higher sensitivity than microscopic examinations, and the interpretation of the test results can be more objective, although evaluated only in a small study population 10,19 and not commercially Multiplex molecular assays have demonstrated excellent diagnostic performance 16,17 ; however, the requirement of special equipment and expensive examination cost can limit their clinical usefulness. Given that most patients with gastroenteritis suffer mild illnesses in the primary care settings, the use of multiplex molecular assays should be reserved for hospitalized or emergency department patients.…”