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Real Time PCR Group B Streptococcus GBS STD STI Test Kit Lyophilized 48 Tests/Kit
Real Time PCR Group B Streptococcus GBS STD STI Test Kit Lyophilized 48 Tests/Kit
Real Time PCR Group B Streptococcus GBS STD STI Test Kit Lyophilized 48 Tests/Kit
Real Time PCR Group B Streptococcus GBS STD STI Test Kit Lyophilized 48 Tests/Kit
Specifications
Brand Name :
Biokey
Model Number :
BIK-QL-H0021S
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 :
48 tests/kit
expiration date :
12 months
Storage :
-20±5℃
Applicable :
Micgene 244/244 IVD（BIO-KEY）
LoD :
500 copies/ml
CV :
≤5%
Description
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:

Real Time PCR Group B Streptococcus GBS STD STI Test Kit Lyophilized 48 Tests/Kit



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!

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Real Time PCR Group B Streptococcus GBS STD STI Test Kit Lyophilized 48 Tests/Kit

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Product Detail
Brand Name :
Biokey
Model Number :
BIK-QL-H0021S
Certification :
CE
Place of Origin :
Guangzhou China
MOQ :
We can produce liquid and lyophilized kits
Price :
USD
Contact Supplier
Real Time PCR Group B Streptococcus GBS STD STI Test Kit Lyophilized 48 Tests/Kit
Real Time PCR Group B Streptococcus GBS STD STI Test Kit Lyophilized 48 Tests/Kit

Guangzhou BioKey Healthy Technology Co.Ltd

Verified Supplier
4 Years
guangzhou
Since 2003
Business Type :
Manufacturer, Distributor/Wholesaler, Exporter, Seller
Main Products :
RT qPCR Machine, Portable qPCR Machine, HPV PCR Kit
Total Annual :
5M-10M
Employee Number :
100~200
Certification Level :
Verified Supplier
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