Description

Description: NZYTech's Group B Streptococcus Real-time PCR Kit, IVD is a qualitative molecular assay indicated for the rapid identification of antepartum colonization of Group B Streptococcus (GBS, Streptococcus agalactiae) in pregnant women. GBS is the pathogen causing the most serious bacterial infections in newborns. This bacterium colonizes the gastrointestinal and the lower genital tract in 10 to 40% of pregnant women and there is a risk that the baby may become infected during delivery. GBS infection in newborns can lead to sepsis, pneumonia, and meningitis. NZYTech's Group B Streptococcus Real-time PCR Kit, IVD provides the complete set of reagents, enzymes, and oligonucleotides (primers and probes) for the qualitative detection of the GBS genome, through common real-time PCR platforms. The assay simplifies and accelerates GBS diagnosis by providing reliable results from vaginal and/or perianal swab samples in less than one hour. Features: - Highly sensitive qualitative detection of Group B Streptococcus - Duplex assay - GBS specific gene and human endogenous gene - Positive control to validate assays - Internal control to confirm extraction / inhibition - Easy workflow with ready-to-use reagents - For professional in vitro diagnostic use only Intended Use: NZYTech's Group B Streptococcus Real-time PCR Kit, IVD, is a molecular test based on real-time PCR technology, intended for the in vitro qualitative detection of Group B Streptococcus (GBS) nucleic acid from extracted from vaginal and/or perianal specimen swabs obtained from antepartum women. Assay results can be used as an aid in determining the colonization status of antepartum women but are not intended to diagnose or monitor treatment of a GBS infection. This kit is intended for use by laboratory trained personnel, specifically instructed in real-time PCR techniques and in vitro diagnostics. Specifications: High sensitivity: detects up to 250 copies/mL of GBS sample (LoD) High throughput: Up to 93 clinical samples (96-well plate) High specificity: proven by in silico analysis and by wet lab testing PCR-platforms: runs on well-established standard real-time PCR-platforms including Applied Biosystems® - QuantStudio™ 5, 7500 FAST and StepOne Plus; Roche®; Lightcycler® 96 Instrument; Bio-Rad® - CFX Opus 96 Real-Time PCR and CFX96 Touch Real-Time PCR Fast time: < 1 h for qPCR program Find the IFU for your product batch

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Short Description

NZYTech's Group B Streptococcus Real-time PCR Kit, IVD is a qualitative molecular assay indicated for the rapid identification of antepartum colonization of Group B Streptococcus (GBS, Streptococcus agalactiae) in pregnant women.