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Product Details:
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| Package: | 24 Tests/kit | Expiration Date: | 12 Months |
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| Storage: | -20±5℃ | Applicable: | Micgene 244/244 IVD（BIO-KEY） |
| LoD: | 5 Copies/μL | CV: | ≤5% |
| High Light: | HSV-1/2 PCR Detection Kit,HSV-2 PCR Detection Kit,CE Herpes Simplex Virus PCR |
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HSV-1&2 real-time PCR detection kit (lyophilized)
--24 tests/kit
Intended use:
This kit, adopting Real-Time PCR-Fluorescence technology, is used for detection of HSV-1&2. It can be used for the laboratory diagnosis and monitoring of HSV-1&2 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 nucleic acid conserved region of HSV-1&2. 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 HSV-1&2 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 nucleic acid extraction is qualified.
Main components:
| No. | Components |
BIK-QL-H0015S1 |
|
|
PCR Enzyme Mix (Lyophilized) |
24 tests/bottle |
| 2 | Positive Control | 100 μL/tube |
| 3 | Negative Control | 100 μL/tube |
| 4 | RNase-free water | 1mL/tube |
| 5 | Paraffin oil | 1.5mL/tube |
Note: Do not mix the components from different batches for detection. The Positive Control of HSV-1&2 and internal control were constructed artificially, and they were not infectious.
Product lyophilization package:
Specimen requirements:
1.Specimen type :
Urethral swabs, cervical swabs or rectal swab.
2.Specimen preservation:
The specimen can be stored for 3 months at -20±5℃ and for a long time below -70℃.
Reaction mix preparation:
Refer to the tables below to prepare the reaction mix:
| 1×volume required | |
| Resuspended master mix | 14 μL |
|
HSV Primer & probe |
1 μL |
| Total volume | 15 μL |
※Multiply the numbers according to the number of tests.
Quality control:
Negative Control, Positive Control and IC of samples must be performed correctly, otherwise the sample results is invalid.
| Ct value | |
| Negative Control | No Ct |
| Positive Control | ≤30 |
| IC of samples | ≤38 |
Data analysis interpretation:
|
FAM (HSV-1) |
VIC/HEX (HSV-2) |
ROX (IC) |
Interpretation test results |
|
|
1 |
- |
- |
- |
Result invalid,test again |
| 2 | + | - | +/- | HSV-1(+) |
| 3 | - | + | +/- | HSV-2(+) |
|
4 |
+ |
+ |
+/- |
HSV-1 and HSV-2(+) |
| 5 | - | - | + | Negative(-) |
NOTE: ‘+’ is positive, ‘-’ is negative.
Operation details please check from IFU!
Contact Person: Ms. Lisa
