Real Time PCR Group B Streptococcus GBS STD STI Test 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:
 

GBS product lyophilization pacakage:

 
Main components:

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:
 

Instrument detection channel selection: FAM and HEX/VIC.
 
Quality control:
 

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!