Preclinical Study for the Evaluation of the Xpert® GI (Gastrointestinal) Panel for use with Rectal Swab Specimens

Aim: To evaluate the preclinical and preliminary performance of the Xpert GI Panel with paired stool and rectal swab specimens as well as preliminary comparison of the Xpert GI Panel against the SOC and/or on-market Nucleic Acid Amplification Test (NAAT)-based panel test.

Cross-sectional study conducted among 900 patients presenting with signs and symptoms of GI Infection in Dar es salaam, Tanzania.

A paired rectal swab and stool specimen will be collected for SOC diagnosis (stool culture/ microscopy/antigen detection test/ on-market NAAT-based panel test). The paired stool and rectal swab specimens from Xpert GI Panel will be compared to the results of the paired stool specimen from the SOC and/or on-market NAAT-based panel test.