|Package:||96 T/kit (carton) / 48 Tests/kit (single Tube)||Specimen:||Feces|
|Specimen Preservation:||3 Days At 4-8 ℃ , 3 Months At -20± 5℃ And For A Long Time Below -70℃||Applicable:||Micgene 244/244 IVD(BIO-KEY)|
|Detection Limit:||500 Copies/mL||CV:||≤5%|
ISO 13485 Clostridium Difficile Test Kit,
Clostridium Difficile Test Kit PCR,
ISO 13485 Digestive Test Kit
Clostridium difficile ( CD ) associated infection PCR Fluorescent probing Taqman test kit
This kit, adopting Real-Time PCR-Fluorescence technology, is used for qualitative detection of Clostridium difficile. It can be used for the laboratory diagnosis and monitoring of the Clostridium difficile infection. The test results are only for clinical reference, not for case confirmation or exclusion.
The specific primers and specific fluorescent probes are designed for the nucleic acid conserved region of Clostridium difficile toxin A and toxin B. The PCR reaction solution and real-time fluorescent quantitative PCR detection technology is applied on the fluorescence quantitative PCR instrument for realizes the rapid detection of CD through the change of fluorescence signal. The detection system contains a human internal control (IC) gene, which is used to monitor whether the specimens and the process of nucleic acid extraction is qualified.
|1||PCR Enzyme Mix (Lyophilized)||48 tests/kit|
|2||CD Primer-Probe Mix||/|
|3||Enzyme Mix Buffer (5×)||/|
|4||Positive Control||100 μL/tube|
|5||Negative Control||100 μL/tube|
Note: Do not mix the components from different batches for detection. The Positive Control of CD and internal control were constructed artificially, and they were not infectious.
The diagnostic kit is applicable to PCR instrument with multi-color fluorescence channel FAM,VIC/HEX and ROX, including Quant Studio5 (ABI), Micgene 244/244 IVD(BIO-KEY).
Reaction Mix Preparation:
Refer to one of the table below to prepare the reaction mix:
|Resuspended master mix||14 μL|
|CD Primer & probe||1 μL|
|Total volume||15 μL|
※Multiply the numbers according to the number of tests.
PCR amplification condition:
PCR amplification according to the following procedure:
(Collection of fluorescence)
Select the detection channels as following:
a) Select FAM channels to detect Clostridium difficile toxin A.
b) Select HEX/VIC channels to detect Clostridium difficile toxin B.
c) Select ROX channel to detect internal control.
Interpretation of test results:
|VIC/HEX (toxin B)||ROX (IC)||Interpretation test results|
|Result invalid,test again|
toxin A and toxin
NOTE: ‘+ ’ is positive, ‘- ’ is negative.
Operation details please check from IFU
Contact Person: Lisa