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| Categories | Herpes Simplex Virus PCR | 
|---|---|
| Brand Name: | Biokey | 
| Model Number: | BIK-QL-H0015 | 
| Certification: | 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: | 96 tests/kit | 
| expiration date: | 12 months | 
| Storage: | -20±5℃ | 
| Applicable: | Micgene 244/244 IVD(BIO-KEY) | 
| LoD: | 5 copies/μL | 
| CV: | ≤5% | 
| Company Info. | 
| Guangzhou BioKey Healthy Technology Co.Ltd | 
| Verified Supplier | 
| View Contact Details | 
| Product List | 
HSV-1&2 real-time PCR detection kit (lyophilized)
--96 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-H0015 | 
1  | PCR Enzyme Mix (Lyophilized)  | 96 tests/bottle  | 
| 2 | HSV Primer-Probe Mix | 100 μL/vial | 
| 3 | Enzyme Mix Buffer (5×) | 400 μL/vial | 
| 4 | Positive Control | 100 μL/tube | 
| 5 | Negative Control | 100 μL/tube | 
| 6 | RNase-free water | 1mL/tube | 
| 7 | Paraffin oil | 1.5mL/tube*2 | 
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.
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!
                                 
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