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Guangzhou BioKey Healthy Technology Co.Ltd |
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HPV Genotype 2+12 High risk(16+18)+Medium risk Real Time PCR Detection Kit (Lyophilized) --24 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.
Main components:
No. | Components | BIK-QL-H0018 |
1 | PCR Enzyme Mix (Lyophilized) | 96 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℃.
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# |
Interpretation of test results:
FAM (12 High-risk HPV types) | VIC/HEX (HPV 16) | ROX (HPV 18) | CY5(IC) | Interpretation test results | |
1 |
- |
- |
- |
- | Result invalid,test again |
2 |
+ |
- |
- |
+/- | 12 High-risk HPV types(+) |
| 3 | - | + | - | +/- | HPV 16(+) |
| 4 | - | - | + | +/- | HPV 18(+) |
5 |
+ |
+ |
- |
+/- | 12 High-risk HPV types, HPV 16(+) |
6 |
+ |
- |
+ |
+/- | 12 High-risk HPV types, HPV 18(+) |
| 7 | - | + | + | +/- | HPV16+18(+) |
| 8 | + | + | + | +/- | 12 High-risk HPV types, HPV16+18(+) |
| 9 | - | - | - | + | Negative(-) |
NOTE: ‘+’ is positive, ‘-’ is negative.
Operation details please check from IFU!
