We use cookies to make your experience better. To comply with the new e-Privacy directive, we need to ask for your consent to set the cookies. Learn more.
SKU
MD04941
Group B Streptococcus Real-time PCR Kit, IVD
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.
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
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
Shipping Conditions | Blue Ice | Storage Conditions | -85 °C to -15 °C | Format | In Vitro Diagnostics (IVD) | Product Category | Predesigned qPCR assays | Compatibility | AB™ 7500, AB™ QuantStudio 5, AB™ StepOnePlus, Bio-Rad® CFX Opus 96, Bio-Rad® CFX96™, Roche LightCycler® 96 System | Marking | CE-IVD | Target Species | Group B Streptococcus (GBS) | Sample Material | DNA | Protocol time | Approx. 60 min (from extracted NA to result) | Number of targets | Duplex | Internal Control | No | Detection Method | Probe Based |
---|
– GBS MMix
– GBS PPMix
– GBS POS
– NTC
Shipping Conditions | Blue Ice | Storage Conditions | -85 °C to -15 °C | Format | In Vitro Diagnostics (IVD) | Product Category | Predesigned qPCR assays | Compatibility | AB™ 7500, AB™ QuantStudio 5, AB™ StepOnePlus, Bio-Rad® CFX Opus 96, Bio-Rad® CFX96™, Roche LightCycler® 96 System | Marking | CE-IVD | Target Species | Group B Streptococcus (GBS) | Sample Material | DNA | Protocol time | Approx. 60 min (from extracted NA to result) | Number of targets | Duplex | Internal Control | No | Detection Method | Probe Based |
---|
Shipping Conditions | Blue Ice | Storage Conditions | -85 °C to -15 °C | Format | In Vitro Diagnostics (IVD) | Product Category | Predesigned qPCR assays | Compatibility | AB™ 7500, AB™ QuantStudio 5, AB™ StepOnePlus, Bio-Rad® CFX Opus 96, Bio-Rad® CFX96™, Roche LightCycler® 96 System | Marking | CE-IVD | Target Species | Group B Streptococcus (GBS) | Sample Material | DNA | Protocol time | Approx. 60 min (from extracted NA to result) | Number of targets | Duplex | Internal Control | No | Detection Method | Probe Based |
---|
CoA
Certificate of Analysis
Manuals
Case Study - Unilabs
Endorsed Technical File - Optimized Pathogen Detection: A compatibility evaluation of Revvity chemagic
Whitepaper - The Synthesis of Scientifics Innovation, Quality and Value
Instructions Manual - DE
Instructions Manual - EN
Instructions Manual - ES
Instructions Manual - FR
Instructions Manual - HR
Instructions Manual - PT