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Product Details:
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| Package: | 48T/box, Single Pcr Tube | Specimen Preservation: | 2 Weeks At 4-8℃, 3 Months At -20± 5℃ And For A Long Time Below -70℃. |
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| Applicable: | Micgene 244/244 IVD(BIO-KEY) | Detection Limit: | 500 Copies/mL |
| CV: | ≤5% | Purpose: | Cervical Cancer Screening |
| High Light: | ISO 13485 Real Time Quantitative PCR Kit,ISO 13485 Real Time HPV PCR Kit,HPV PCR Kit Taqman Probe Assay |
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Real Time quantitative PCR High risk Human Papillomavirus ( HPV ) Nucleic Acid Taqman DNA Detection Kit
Intended use:
This kit, adopting Real-Time PCR-Fluorescence technology, is used for qualitative detection of HPV 16+ 18, which usually causes cervical cancer for women. Thus this PCR assay 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
Contact Person: Ms. Lisa
