GeneProof Borrelia burgdorferi PCR Kit
CE IVD
PRODUCT DETAIL
The PCR kit is designed for detection of clinically important Borrelia species from the Borrelia burgdorferi sensu lato group causing Lyme disease and for detection of Borrelia miyamotoi causing tick-borne relapsing fever, by the real-time Polymerase Chain Reaction (PCR) method.
The detection consists in amplification of the gene sequence encoding 16S rRNA and in measurement of fluorescence increase. The B. burgdorferi presence is indicated by the FAM fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR by amplification products. The kit is designed for in vitro diagnostics and provides qualitative detection.
TECHNICAL SPECIFICATION
Technology | real-time PCR |
Type of Analysis | qualitative |
Target Sequence | the gene sequence encoding 16S rRNA |
Specificity | B. burgdorferi sensu stricto, B. garinii, B. afzelii, B. andersonii, B. bissettii, B. valaisiana, B. lusitaniae, B. japonica, B. tanukii, B. turdi, B. sinica, B. miyamotoi, B. mayonii, B. spielmanii, B. bavariensis, B. kurtenbachii, 100 % |
Sensitivity (LoD) | reaches up to 0.568 cp/μl with the probability of 95 % (on Amplirun® Borrelia burgdorferi DNA control, Vircell) |
Extraction / Inhibition Control |
PCR Inhibition control (ISIN version) PCR Inhibition and DNA extraction efficiency control (ISEX version) |
Validated Specimen | CSF, plasma, serum, tick, urine, whole blood |
Storage | -20 ± 5 °C |
Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
Validated Instruments | croBEE Real-Time PCR System Applied Biosystems 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System LightCycler® 2.0 / 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler |
Required Detection Channels | FAM, HEX |
Quality Control | quality management system is certified in compliance with the requirements of the standard ISO 13485 |
External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment Panels - results at www.geneproof.com |
Certification | CE IVD for in vitro Diagnostics Use |
ORDER INFORMATION
Product name | Cat. No. | Technology | Package |
GeneProof Borrelia burgdorferi PCR Kit | BB/ISIN/025 | real-time PCR | 25 reactions |
GeneProof Borrelia burgdorferi PCR Kit | BB/ISIN/050 | real-time PCR | 50 reactions |
GeneProof Borrelia burgdorferi PCR Kit | BB/ISIN/100 | real-time PCR | 100 reactions |
GeneProof Borrelia burgdorferi PCR Kit | BB/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Borrelia burgdorferi PCR Kit | BB/ISEX/050 | real-time PCR | 50 reactions |
GeneProof Borrelia burgdorferi PCR Kit | BB/ISEX/100 | real-time PCR | 100 reactions |