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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: | Laboratory STD STI Test Kit,GBS STD STI Test Kit,Group B Streptococcus PCR 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-H0021 |
|
1 |
PCR Enzyme Mix(Lyophilized) |
96 tests/bottle |
| 2 | GBS 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 GBS and internal control were constructed artificially, and they were not infectious.
GBS product lyophilization pacakage:
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
