| Categories | HPV PCR Kit |
|---|---|
| Brand Name: | Biokey |
| Model Number: | BIK-QL-H005S |
| Certification: | ISO 13485,CE |
| Place of Origin: | Guangzhou China |
| MOQ: | We can produce liquid and lyophilized kits |
| Price: | USD |
| Payment Terms: | L/C, T/T, Western Union |
| Supply Ability: | 100,000 per day |
| Delivery Time: | Depending on order quantity |
| Packaging Details: | Carton package |
| Package: | 48 T/kit(single tube) |
| Specimen: | Cervical shedding cells, vaginal secretion swab |
| Applicable: | Micgene 244/244 IVD(BIO-KEY) |
| Detection limit: | 500 copies/mL |
| CV: | ≤5% |
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
|
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