Group B streptococcus(GBS) real-time PCR detection kit
(lyophilized)
--48 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.
GBS product lyophilization pacakage:
Main components:
| No. | Components | BIK-QL-H0021S |
1 | PCR Enzyme Mix(Lyophilized) | 48 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 |
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.
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.
Performance indexes of product:
- Accuracy:Use national reference products or enterprise
positive/negative reference products for testing, and the results
are all positive/negative.
- Detection limitation:500 copies/ml.
- Precision: The coefficient of variation (CV) of Ct values is≤5%.
- Specificity:The detection results of this kit have no cross
reaction with Candida albicans, Streptococcus pneumoniae,
Enterococcus, Group A Streptococcus, Group C Streptococcus, Group G
Streptococcus species, S. green, Enterococcus faecalis,
Enterococcus faecium, Neisseria gonorrhoeae, Lactobacillus
acidophilus, Treponema pallidum, Chlamydia trachomatis, Mycoplasma
hominin, Trichomonas vaginalis, herpes simplex virus type and Human
papillomavirus.
Operation details please check from IFU!
