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GeneProof Borrelia PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

HIGH SENSITIVITY

  • Secured by targeting the multicopy sequence of the 16S rRNA gene
  • 100% diagnostic sensitivity

WIDE RANGE OF VALIDATED CLINICAL MATERIALS

  • Plasma, serum, whole blood, CSF, urine and tick

HIGH SPECIFICITY

  • 15 Borrelia burgdorferi sensu lato strains worldwide
  • Borrelia burgdorferi sensu stricto
  • Borrelia miyamotoi

EASY-TO-USE CONCEPT

  • Single tube Ready-to-Use Master Mix contains all components for PCR amplification
  • No additional PCR reagents pipetting necessary

CONTAMINATION PREVENTION

  • Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating carryover contamination

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof Borrelia PCR Kit BOR/GP/025 real-time PCR 25 reactions
GeneProof Borrelia PCR Kit BOR/GP/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_BB_QCMD_12_20_EN
pdf, [171.03 kB]
; GP_BB_QCMD_09_21_EN_02
pdf, [170.04 kB]
; GP_BB_QCMD_09_21_EN_01
pdf, [169.11 kB]
; GP_BB_Instand_06_21_EN
pdf, [901.17 kB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Technology Real-time PCR
Type of Analysis Qualitative
Target Sequence Gene encoding 16S rRNA
Analytical Specificity

Borrelia burgdorferi sensu stricto, B. garinii, B. afzelii, B. andersonii, B. bissettii, B. valaisiana, B. lusitaniae, B. japonica, B. tanukii, B. turdi, B. sinica, B. mayonii, B. spielmanii, B. bavariensis, B. kurtenbachii, B. miyamotoi (Asian genotype), 100 %

Analytical Sensitivity (LoD with 95% probability)

0.568 cp/μl (on Amplirun® Borrelia burgdorferi DNA control, Vircell)

Diagnostic Specificity 98.15 % (Cl95%: 88.82 % – 99.90 %)
Diagnostic Sensitivity 100.00 % (Cl95%: 96.93 % – 100.00 %)
Positive Predictive Value 99.35 % (Cl95%: 95.86 % – 99.97 %)
Negative Predictive Value 100.00 % (Cl95%: 91.58 % – 100.00 %)
Extraction / Inhibition Control

PCR inhibition and DNA extraction efficiency control by Internal Control

Validated Specimen CSF, plasma, serum, tick, urine, whole blood (EDTA)
Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit
Instruments

croBEE Real-Time PCR System
AMPLilab Real-Time PCR System
Applied Biosystems 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 Real-Time PCR System
CFX Connect™ / CFX96™/ Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LightCycler® 2.0 / 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
StepOne™ / StepOne Plus™ Real-Time PCR System
SLAN® Real-Time PCR System

Required Detection Channels FAM, HEX/JOE/VIC
External Quality Assessment Regularly tested in QCMD and Instand e.V. External Quality Assessment Panels results at www.geneproof.com

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.55 MB]
; GP_BOR_Advisory Notice_06_22_EN
pdf, [821.57 kB]
; GP_BOR_Instruction_for_Use_EN
pdf, [307.52 kB]

Declaration of Conformity

; GP_BOR_Declaration_of_Conformity_EN
pdf, [607.96 kB]

MSDS

; GP_BOR_Safety_Data_Sheet_EN
pdf, [275.23 kB]

PCR Template

; GP_Borrelia burgdorferi_Mic
micassay, [21.97 kB]
; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_BOR_Leaflet_EN
pdf, [139.25 kB]

Manual

; AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
; Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
; croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
; LightCycler 2.0_EN
pdf, [1.8 MB]
; LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
; LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
; Mic qPCR Cycler_EN
pdf, [2.33 MB]
; QuantStudio 3/5 Real-Time PCR System_EN
pdf, [1.81 MB]
; Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
; SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
; StepOne/StepOne Plus Real-Time PCR System_EN
pdf, [4.42 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.

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