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Brand Name : Biokey
Model Number : BIK-QL-H0019
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 : 1×10000 copies/ml
CV : ≤5%
 
Intended use:
 
Principle:
 
 
Main components:
| No. | Components | BIK-QL-H0019 | 
| 1 | PCR Enzyme Mix(Lyophilized) | 96 tests/bottle | 
| 2 | MG 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 | 
Specimen requirements:
 
1. Specimen type
Urine or urethral swabs for men, and female urine, cervical swabs, or vaginal swab samples
2. Specimen Preservation
The specimen can be stored for 3 months at -20±5℃ and for a long time below -70℃
PCR Amplification condition:
 
PCR amplification according to the following procedures:
 
| Step | Cycle number | Temperature | Time | 
| 1 | 1 | 95℃ | 3min | 
| 2 | 40 | 95℃ | 10s | 
| 60℃ | 30s collect fluorescent | 
Instrument detection channel selection: FAM and HEX/VIC.
 
Quality control:
 
| Ct value | |
| Negative Control | No Ct | 
| Positive Control | ≤30 | 
| IC of samples | ≤38 | 
Note: Negative Control, Positive Control and IC of samples must be performed correctly, otherwise the sample results is invalid.
 
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# | 
 Operation details please check from IFU!
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