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PCR Multiplex Amplification Clostridium difficile ( CD ) Fluorescence Taqman probing kit
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 |
| 1 | PCR Enzyme Mix (Lyophilized) | 96 tests/bottle |
| 2 | CD Primer-Probe Mix | 100 μL/vial |
| 3 | Enzyme Mix Buffer (5×) | 400 μL/vial |
| 4 | Positive Control | 100 μL/tube |
| 5 | Negative Control | 100 μL/tube |
| 6 | RNase-free water | 1mL/tube |
| 7 | Paraffin oil | 1.5mL/tube*2 |
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