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Brand Name : Biokey
Model Number : BIK-QL-H005
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)
Specimen preservation : 2 weeks ar 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%
Real Time quantitative PCR High risk Human Papillomavirus ( HPV ) Nucleic Acid DNA Detection Kit
Intended use:
This kit, adopting Real-Time PCR-Fluorescence technology, is used for qualitative detection of HPV 16+ 18. It can be used for the laboratory diagnosis and monitoring of the virus 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 conserved region of HPV 16+ 18. 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 HPV 16+ 18 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 the nucleic acid extraction is qualified.
Product components:
No. | Components | BIK-QL-H005 |
1 | PCR Enzyme Mix (Lyophilized) | 96 tests/bottle |
2 | HPV 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 HPV and internal control were constructed artificially, and they were not infectious.
Data anlysis:
The following sample results are possible:
Ct value | Result Analysis | |
1# | No Ct | Negative |
2# | ≤38 | Positive |
3# | 38~40 | Re-test; if it is still 38~40, report as 2# |
Reaction mix preparation :
Refer to one of the table below to prepare the reaction mix:
1×volume required | |
Resuspended master mix | 14 μL |
HPV Primer-Probe Mix | 1 μL |
Total volume | 15 μL |
※Multiply the numbers according to the number of tests.
Interpretation of test results:
FAM (HPV16) | VIC/HEX (HPV18) | ROX(IC) | Interpretation test results | |
1 | - | - | - | Result invalid, test again |
2 | + | - | +/- | HPV16(+) |
3 | - | + | +/- | HPV18(+) |
4 | + | + | +/- | HPV16 and HPV18(+) |
5 | - | - | + | Negative(-) |
NOTE: ‘+ ’ is positive, ‘- ’ is negative.
Operation details please check from IFU
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Real Time Hpv Real Time Pcr Kit High Risk Micgene Nucleic Acid DNA Detection Kit Images |