Human Papilloma Virus HPV 16 / 18 genotype RT PCR Fluorescence
probing PCR test 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-H005S |
| 1 | PCR Enzyme Mix (Lyophilized) | 48 tests/kit |
| 2 | HPV Primer-Probe Mix | / |
| 3 | Enzyme Mix Buffer (5×) | / |
| 4 | Positive Control | 100 μL/tube |
| 5 | Negative Control | 100 μL/tube |
| 6 | RNase-free water | 1mL/tube |
| 7 | Paraffin oil | 1.5mL/tube |
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# |
Specimen requirements:
1. Specimen type
Cervical shedding cells, genitourinary tract secretions.
2. Specimen collection and transportation
Clean the sampling site with sterile saline, and then use an
epithelial brush (cervical brush, swab, etc.) to collect exfoliated
cells from the cervix or genitourinary tract, epithelial cells at
the lesion, secretions, etc. swabs, etc.) into a sterile storage
tube and seal it for inspection.
3. Specimen preservation
The specimen can be stored for 2 weeks ar 4-8℃ , 3 months at -20±
5℃ and for a long time below -70℃
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
