High accuracy Medical diagnostic Hp PCR kit Helicobacter pylori
(Hp) Real Time PCR Detection Kit (Lyophilized)
Intended use:
This kit, adopting Real-Time PCR-Fluorescence technology, is used
for detection of Hp. It can be used for the laboratory diagnosis
and monitoring of the Hp 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 Hp. The PCR reaction
solution and real-time fluorescent quantitative PCR detection
technology is applied on the fluorescence quantitative PCR
instrument to realize the rapid detection of Hp 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-H008S |
| 1 | PCR Enzyme Mix (Lyophilized) | 48 tests/kit |
| 2 | Hp Primer-Probe Mix | / |
| 3 | Enzyme Mix Buffer (5×) | / |
| 4 | Positive Control | 100 μL/tube |
| 5 | Negative Control | 100 μL/tube |
| 6 | RNase-free water | 1mL/tube |
| 7 | Paraffin oil | 1.5mL/tube |
Note: Do not mix the components from different batches for
detection. The Positive Control of Hp 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 |
| Hp 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 Hp.
b) Select HEX/VIC channel to detect internal control.
Product picture:
Operation details please check from IFU
