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Product Details:
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| Package: | 96 Tests/kit | Expiration Date: | 12 Months |
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| Storage: | -20±5℃ | Applicable: | Micgene 244/244 IVD（BIO-KEY） |
| LoD: | 20 Copies/reactions | CV: | ≤5% |
| High Light: | Lyophilized HPV PCR Kit,16+18 HPV PCR Kit,HPV Real Time PCR Kit |
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HPV Genotype 2+12 High risk(16+18)+Medium risk Real Time PCR Detection Kit (Lyophilized) --96 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-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℃.
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# |
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!
Contact Person: Ms. Lisa
