Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus

Short Description:

This kit is intended for the in vitro qualitative detection of the nucleic acid DNA of group B streptococcus in rectal swab samples, vaginal swab samples or mixed rectal/vaginal swab samples from pregnant women at 35 to 37 gestational weeks with high risk factors and at other gestational weeks with clinical symptoms such as premature rupture of membrane and threatened premature labor.


Product Detail

Product Tags

Product Name

HWTS-UR010A-Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EPIA) for Group B Streptococcus

Epidemiology

Group B Streptococcus (GBS), also known as streptococcus agalcatiae, is a gram-positive pathogen that normally resides in the lower digestive tract and urogenital tract of the human body. About 10%-30% of pregnant women have GBS vaginal residence. Pregnant women are susceptible to GBS due to the changes in internal environment of the reproductive tract caused by changes in hormone levels in the body, which can lead to adverse pregnancy outcomes such as premature delivery, premature rupture of membranes, and stillbirth, and can also lead to puerperal infections in pregnant women. In addition, 40%-70% of women infected with GBS will transmit GBS to their newborns during delivery through the birth canal, causing severe neonatal infectious diseases such as neonatal sepsis and meningitis. If the newborns carry GBS, about 1%-3% of them will develop early invasive infections, and 5% will lead to death. Neonatal group B streptococcus is associated with perinatal infection and is an important pathogen of severe infectious diseases such as neonatal sepsis and meningitis. This kit accurately diagnoses the infection of group B streptococcus to minimize the incidence rate and harm of it in of pregnant women and newborns as well as the unnecessary economic burden caused by the harm.

Channel

FAM GBS nucleic acid
ROX internal reference

Technical Parameters

Storage
Liquid ≤-18℃ In dark 
Shelf-life 9 months
Specimen Type Genital tract and rectal secretions
Tt <30
CV ≤10.0%
LoD 500Copies/mL
Specificity No cross-reactivity with other genital tract and rectal swab samples such as Candida albicans, Trichomonas vaginalis, Chlamydia trachomatis, Ureaplasma urealyticum, Neisseria gonorrhoeae, Mycoplasma hominis, Mycoplasma genitalium, Herpes simplex virus, Human Papillomavirus, Lactobacillus, Gardnerella vaginalis, Staphylococcus aureus, national negative references N1-N10 (Streptococcus pneumoniae, Pyogenic streptococcus, Streptococcus thermophilus, Streptococcus mutans, Streptococcus pyogenes, Lactobacillus acidophilus, Lactobacillus reuteri, Escherichia coli DH5α, and Saccharomyces albicans) and human genomic DNA
Applicable Instruments Easy Amp Real-time Fluorescence Isothermal Detection System(HWTS1600)

Applied Biosystems 7500 Real-Time PCR Systems

Applied Biosystems 7500 Fast Real-Time PCR Systems

QuantStudio®5 Real-Time PCR Systems

SLAN-96P Real-Time PCR Systems

LightCycler®480 Real-Time PCR system

LineGene 9600 Plus Real-Time PCR Detection System

MA-6000 Real-Time Quantitative Thermal Cycler

BioRad CFX96 Real-Time PCR System

BioRad CFX Opus 96 Real-Time PCR System

Work Flow

Option 1.

Recommended extraction reagent: Macro & Micro-Test Sample Release Reagent (HWTS-3005-8).

Option 2.

Recommended extraction reagent: Macro & Micro-Test Viral DNA/RNA Kit (HWTS-3004-32, HWTS-3004-48, HWTS-3004-96) and Macro & Micro-Test Automatic Nucleic Acid Extractor (HWTS-3006).


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