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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

FeatureBenefit
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

Product Spec NameProduct Spec Data
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 NumberDescription
M307

Solana C. difficile Assay Kit

M108

Quidel Molecular C. difficile Control Set

Product Documentation