Specifications
Brand Name :
Biokey
Model Number :
BIK-QL-H006 / BIK-QL-H006S
Certification :
ISO 13485,CE
Place of Origin :
Guangzhou China
MOQ :
We can produce liquid and lyophilized kits
Price :
USD
Payment Terms :
L/C, T/T, Western Union
Supply Ability :
100,000 per day
Delivery Time :
Depending on order quantity
Packaging Details :
Carton package
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%
Description

Clostridium difficile ( CD ) Real Time PCR fluorescent probing DNA Detection Kit ( Lyophilized )

Intended use:

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.

Test Principle:


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.


Product components:

No. Components BIK-QL-H006 BIK-QL-H006S
1

PCR Enzyme Mix

(Lyophilized)

96 tests/bottle 48 tests/kit
2 CD Primer-Probe Mix 100 μL/vial /
3 Enzyme Mix Buffer (5×) 400 μL/vial /
4 Positive Control 100 μL/tube 100 μL/tube
5 Negative Control 100 μL/tube 100 μL/tube
6 RNase-free water 1mL/tube 1mL/tube
7 Paraffin oil 1.5mL/tube*2 1.5mL/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.


Compatible instruments:

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:

1×volume required
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:

Step Cycle Temperature Time
1 1 94℃ 3 min

2

40

94℃ 10 s
60℃

30 s

(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:

FAM

(toxin A)

VIC/HEX (toxin B) ROX (IC) Interpretation test results
1

-

-

-

Result invalid,test again
2 + - +/- toxin A(+)
3 - + +/- toxin B(+)
4 + + +/-

toxin A and toxin

B(+)

5 - - + Negative(-)

NOTE: ‘+ ’ is positive, ‘- ’ is negative.

Operation details please check from IFU

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Real Time PCR Clostridium Difficile C Diff Digestive Fluorescent Probing PCR Kit

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Brand Name :
Biokey
Model Number :
BIK-QL-H006 / BIK-QL-H006S
Certification :
ISO 13485,CE
Place of Origin :
Guangzhou China
MOQ :
We can produce liquid and lyophilized kits
Price :
USD
Contact Supplier
Real Time PCR Clostridium Difficile C Diff Digestive Fluorescent Probing PCR Kit
Real Time PCR Clostridium Difficile C Diff Digestive Fluorescent Probing PCR Kit

Guangzhou BioKey Healthy Technology Co.Ltd

Verified Supplier
3 Years
guangzhou
Since 2003
Business Type :
Manufacturer, Distributor/Wholesaler, Exporter, Seller
Total Annual :
5M-10M
Employee Number :
100~200
Certification Level :
Verified Supplier
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