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
