Solana C. difficile Assay-蚂蚁淘商城

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Solana C. difficile Assay

2024-04-27

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

Solana C. difficile Assay

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

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/mLCCUG 20309 4.90E+03CFU/mLGenomic DNA: ATCC® BAA-1382DQ™ 15 copy/assay