PCG® I-GBS Real-time PCR Kit
PCG® I-GBS Real-time PCR Kit
PCG® I-GBS Real-time PCR Kit

PCG® I-GBS Real-time PCR Kit

PCG® I-GBS Real-time PCR Kit

Principle: Multiplex Real-time PCR using Taqman Probe

Intended use: Detect cfb gene of Group B Streptococcus (GBS agalactiae) using internal control

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Overview

PCG® I-GBS Real-time PCR Kit is designed to detect Group B Streptococcus (GBS) in vaginal-rectal swabs from pregnant women. This kit amplifies a 199 bp DNA sequence of the cfb gene and measures fluorescence increase for accurate detection. Utilizing "hot start" technology, it minimizes non-specific reactions, ensuring high specificity and maximum sensitivity up to 100 CFU/mL. The kit is compatible with various Real-time PCR instruments.

Specification

Regulatory Status RUO
Intended User For professional use in laboratories with trained 
Technology Multiplex Real-time PCR using TaqMan Probes
Type of Analysis Qualitative
Target Sequence cfb gene of GBS
Analytical Specification In silico analysis of 11 GBS variants (la, lb, lc, ll, lll, IV, V, VI, VII, VIII, ND), 100%
Analytical Sensitivity (LOD) 100 CFU/ mL
Cross-reactivity No cross-reactions between Group B Streptococcus and 13 other species (S. aureus, E. faecium, E. coli, H. influenzae, K. pneumoniae, A. hydrophila, A. baumannii, P. aeruginosa, E. faecalis, S. mitis, C. albicans, C. glabrata, C. tropicalis)
Repeatability Coefficient of variation (CV) ≤ 5%
Reproducibility Coefficient of variation (CV) ≤ 5%
Extraction/ Inhibition Control Proper sampling, DNA extraction efficiency and PCR inhibition control by Internal Control (beta-Actin gene)
Validated Specimen Vaginal – rectal swab
Validated Extraction Methods
PCG® GBS MagBead Automated DNA Extraction Kit
PANAMAX Viral DNA/ RNA Extraction Kit
Instruments 
QuantStudio™ 3 Real-Time PCR System
QuantStudio™ 5 Real-Time PCR System
QuantStudio™ 7 Real-Time PCR System
CFX96/ CFX96 Dx Real-Time PCR Detection System
Required Detection Channels
FAM: Detect GBS
HEX/ VIC: Detect Internal Control
Storage 12 months, -20ºC (±5ºC)

Workflow

Order information

 

Product name Package REF
PCG® I-GBS Real-Time PCR Kit
50 tests/ kit PR2600050

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Best possible sensitivity and specificity, Easy-to-Use concept

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ISO 13485:2016 certification

Phacogen factory is EN ISO 13485:2016 certified, complying with TUV Rheinland
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