Performance evaluation of Cepheid Xpert Norovirus kit with a user-modified protocol

Area of Science:

• Clinical diagnostics
• Molecular biology
• Gastroenterology

Background:

• Norovirus is a leading cause of gastroenteritis worldwide.
• Accurate and rapid diagnostic methods are crucial for outbreak control.
• Existing diagnostic methods may require complex sample preparation.

Purpose of the Study:

• To evaluate the performance of the Cepheid Xpert® Norovirus assay.
• To compare the Xpert assay against a validated laboratory-developed test (LDT).
• To assess the assay's ability to detect norovirus genogroups I and II in clinical stool samples.

Main Methods:

• The Cepheid Xpert® Norovirus assay was used to test 85 stool samples.
• Results were compared to a clinically validated laboratory-developed test (LDT).
• Real-time reverse transcription polymerase chain reactions (RT-PCRs) were employed for detection.

Main Results:

• The Xpert assay demonstrated perfect concordance (kappa=1.00) with the LDT.
• 12 norovirus genogroup I (GI), 42 GII-positive, 1 coinfection, and 30 negative samples were identified.
• No cross-reactivity with rotavirus was observed, and PCR inhibition was minimal.

Conclusions:

• The Cepheid Xpert® Norovirus kit provides accurate and reliable detection of norovirus GI and GII.
• The automated assay offers advantages in sample processing and mitigation of PCR inhibition.
• This assay is a valuable tool for clinical diagnostics and norovirus outbreak surveillance.