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
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
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR System

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

*Validated Instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
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