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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: | 500 Copies/ml | CV: | ≤5% |
| High Light: | GBS PCR Detection Kit,Group B Streptococcus Test Kit,500 copies/ml STD STI Test Kit |
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Intended use:
This kit, adopting Real-Time PCR-Fluorescence technology, is used for detection of GBS. It can be used for the laboratory diagnosis and monitoring of GBS infection. The test results are only for clinical reference, not for case confirmation or exclusion.
Principle:
Main components:
| No. | Components |
BIK-QL-H0021S1 |
|
1 |
PCR Enzyme Mix(Lyophilized) |
24 tests/kit |
| 2 | Positive Control | 100 μL/tube |
| 3 | Negative Control | 100 μL/tube |
| 4 | RNase-free water | 1mL/tube |
| 5 |
Paraffin oil |
1.5mL/tube |
Specimen requirements:
1. Specimen type
Vaginal, rectal, or combined vaginal and rectal swabs of pregnant women.
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.
Compatible instruments:
The diagnostic kit is applicable to PCR instrument with multi-color fluorescence channel FAM and HEX/VIC, including Quant Studio5 (ABI), Micgene 244/244 IVD (BIO-KEY).
Operation details please check from IFU!
Contact Person: Ms. Lisa
