|Package:||96 T/kit (carton)||Specimen:||Biopsy Samples Of Human Gastric Mucosa, Saliva, Dental Plaque, Feces, Etc.|
|Specimen Preservation:||Be Stored For 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%|
Fluorescent Quantitative H Pylori Test Kit,
Digestive Test Kit ISO 13485,
ISO 13485 pcr kit for h pylori
Fluorescent quantitative Hp PCR kit Helicobacter pylori (H.p) Real Time PCR Detection Kit (Lyophilized)
This kit, adopting Real-Time PCR-Fluorescence technology, is used for detection of H.p. 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.
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.
|1||PCR Enzyme Mix (Lyophilized)||96 tests/bottle|
|2||Hp 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|
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.
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|
|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:
(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.
Operation details please check from IFU
Contact Person: Ms. Lisa