Guangzhou BioKey Healthy Technology Co.Ltd
| 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% |
| Brand Name | Biokey |
| Model Number | BIK-QL-H005 |
| Certification | ISO 13485,CE |
| Place of Origin | Guangzhou China |
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Product Specification
| 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% | Brand Name | Biokey |
| Model Number | BIK-QL-H005 | Certification | ISO 13485,CE |
| Place of Origin | Guangzhou China | ||
| High Light | Hpv Real Time Pcr Kit High Risk ，Real Time Hpv Real Time Pcr Kit ，Micgene Nucleic Acid DNA Detection Kit | ||
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
Company Details
Business Type:
Manufacturer,Distributor/Wholesaler,Exporter,Seller
Year Established:
2003
Total Annual:
5M-10M
Employee Number:
100~200
Ecer Certification：
Verified Supplier
Bio key Health is a high-tech enterprise with integrating R&D, production and sales&marketing in Guangzhou. Since 2003. Bio Key was founded by the "Thousand Talents Program" entrepreneurial team and the overseas senior automation equipment development engineer team. &n... Bio key Health is a high-tech enterprise with integrating R&D, production and sales&marketing in Guangzhou. Since 2003. Bio Key was founded by the "Thousand Talents Program" entrepreneurial team and the overseas senior automation equipment development engineer team. &n...
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