HPV Genotype 2+12 High risk(16+18)+Medium risk Real Time PCR
Detection Kit (Lyophilized) --48 tests/kit
Intended use:
This kit, adopting Real-Time PCR-Fluorescence technology, is used
for qualitative detection of 14 types of HPV(16, 18, 31, 33,
35, 39, 45, 51, 52, 56, 58, 59, 66, 68). 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.
Principle:
The specific primers and specific fluorescent probes are designed
for the conserved region of HPV(16, 18, 31, 33, 35, 39,
45, 51, 52, 56, 58, 59, 66, 68). 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 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.
NG product lyophilization pacakage:
Main components:
No | Components | BIK-QL-H 0018S |
1 | PCR Enzyme Mix (Lyophilized) | 48 tests/kit |
| 2 | Positive Control | 100 μL/tube |
| 3 | Negative Control | 100 μL/tube |
| 4 | Dilution Solution | 1mL/tube |
| 5 | Paraffin oil | 1.6mL/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.
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 at 4-8℃, 3 months at -20±5℃ and for a long time below -70℃.
Quality control:
Negative Control: None of the FAM, VIC/HEX, ROX& Internal Control
(CY5) channels have a Ct value or Ct ＞38;
Positive Control: FAM, VIC/HEX, ROX& Internal Control (CY5)
channels Ct ≤ 30;
The above two items should be met simultaneously in one experiment.
Otherwise, the experiment is invalid and should be repeated.
Data analysis and interpretation:
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# |
Operation details please check from IFU!
