Group B streptococcus(GBS) real-time PCR detection kit
(lyophilized)
--96 tests/kit
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:
The specific primers and specific fluorescent probes are designed
for the nucleic acid conserved region of GBS. 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 GBS 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-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!
