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| 货号： | QD-003 |
| 保存条件： | 详见官方网站 |
| 供应商： | 钰博生物 |
| 保质期： | 详见说明书 |
| 英文名： | Solana C. difficile Assay |
| 数量： | 大量 |
The Solana C. difficile Assay is an in vitro diagnostic test for the direct, qualitative detection of the Clostridium difficile Toxin A gene (tcdA) in unformed stool specimens of patients suspected of having 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 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®.
Features & Benefits
| Feature | Benefit |
|---|---|
| HDA technology | HDA technology |
| Lyophilized Master Mix reagent | Easy-to-use format, just add processed sample to rehydrate |
| Small, easy-to-use instrument | Small, easy-to-use instrument |
| CLIA moderately complex | CLIA moderately complex |
| Refrigerated storage | Refrigerated storage |
| Specimen type | Raw stool sample |
Product Specifications
| Sample type | Unformed stool |
| Volume/vial | 2.0 mL |
| Time to results | 30 minutes |
| Reagent storage conditions | 25ᵒC ± 2ᵒ for up to 1 day or 2°C to 8°C for up to 6 days in sterile container |
| Control storage conditions | 2˚C to 8˚C |
| Sensitivity to enhanced toxigenic culture | 93% |
| Specificity to enhanced toxigenic culture | 99.2% |
| LOD | ATCC BAA-1805 9.13E+03 CFU/mL CCUG 20309 4.90E+03CFU/mL Genomic DNA: ATCC® BAA-1382DQ™ 15 copy/assay |
Ordering Information
| Catalog Number | Description |
|---|---|
| M307 | Solana C. difficile Assay Kit |
| M108 | Quidel Molecular C. difficile Control Set |
Product Documentation
 Package Insert |
| Procedure Card |
| CLSI |
| FAQ |
| Quiz |
| SDS |
| Sales Sheet |
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