The Solana C. difficile Assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridioides (Clostridium) difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having Clostridioides (Clostridium) difficile-infection (CDI). The Solana C. difficile Assay is intended for use as an aid in diagnosis of CDI. The assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly-conserved fragment of the Toxin A gene sequence.

The Solana C. difficile Assay combines simple sample processing and Helicase-Dependent Amplification (HDA) performed in Solana for the detection of toxigenic Clostridioides (Clostridium) difficile directly from CDI-suspected diarrheal specimens.

In Solana, the target sequence is amplified by specific primers and detected by a specific fluorescence probe included in the Reaction Tube. A competitive process control (PRC) is included in the Lysis Tube to monitor sample processing, inhibitory substances in clinical samples, reagent failure or device failure. The PRC is amplified by the target-specific primers and detected by a PRC specific fluorescence probe.

Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s four USB ports. Solana C. difficile is supported by the power of Virena^®.