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 HDA performed on the Solana platform for the detection of toxigenic Clostridioides (Clostridium) difficile directly from CDI–suspected diarrheal specimens.
On Solana platform, 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, can be printed, and are capable of being sent to the LIS and exported through one of Solana’s four USB ports. The Solana C. difficile Assay is supported by the power of Virena® System.
Catalog number: M307
Description: Solana C. difficile Assay Kit
Catalog number: M308
Description: Quidel Molecular C. Difficile Control Set
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 HDA performed on the Solana platform for the detection of toxigenic Clostridioides (Clostridium) difficile directly from CDI–suspected diarrheal specimens.
On Solana platform, 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, can be printed, and are capable of being sent to the LIS and exported through one of Solana’s four USB ports. The Solana C. difficile Assay is supported by the power of Virena® System.
Catalog number: M307
Description: Solana C. difficile Assay Kit
Catalog number: M308
Description: Quidel Molecular C. Difficile Control Set
Features & benefits
Easy reagent format, just add processed sample to rehydrate
Small and easy-to-use instrument
Long shelf life – two years from date of manufacture
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- Specifications
| Product specification | |
| Sample type | Unformed stool |
| Volume/vial | 2.0 mL |
| Time to results | 30 minutes |
| Reagent storage conditions | 25°C ± 2°C for up to 1 day or 2°C to 8°C for up to 6 days in sterile container |
| Controls storage conditions | 2°C to 8°C |
| Sample preparation storage conditions | 2°C to 25°C |
| Sensitivity to enhanced toxigenic culture | 93% |
| Specificity to enhanced toxigenic culture | 99.2% |
| LOD | ATCC BAA–1805: 9.13x103 CFU/mL CCUG 20309: 4.90x103 CFU/mL Genomic DNA: ATCC® BAA–1382DQ™ 15 copy/assay |
| Processed sample needed to test | 5 µL |
| Shelf life | 24 months |
