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GeneProof Hepatitis B Virus (HBV) PCR Kit

CE 1023 IVD

PRODUCT ADVANTAGES

 

HIGH SPECIFICITY

  • Secured by targeting specific conservative DNA sequence of P gene
  • Prevents detection failure caused by the occurrence of mutations (including safe detection of core and pre-core mutants)
  • Detection of all HBV genotypes A – H
  • 100% diagnostic specificity

HIGH SENSITIVITY

  • Ensures excellent sensitivity up to 13.9 IU/ml
  • 100% diagnostic sensitivity

W.H.O. STANDARD BASED QUANTIFICATION

  • Precise and fully traceable quantification according to 4th WHO International Standard NIBSC 10/266

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

CE1023IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name REF Technology Packaging
GeneProof Hepatitis B Virus (HBV) PCR Kit HBV/ISEX/025 real-time PCR 25 reactions
GeneProof Hepatitis B Virus (HBV) PCR Kit HBV/ISEX/100 real-time PCR 100 reactions

Product Leaflet

Product Leaflet

; GP_HBV_Leaflet_EN
pdf, [217.54 kB]
Choose all

EQA results

EQA results

; GP_HBV_croBEE_QCMD_4_2023_EN_01
pdf, [193.3 kB]
; GP_HBV_INSTAND_3_2023_EN
pdf, [1.06 MB]
; GP_HBV_QCMD_8_22_EN
pdf, [182.98 kB]
; GP_HBV_QCMD_04_22_EN
pdf, [188.4 kB]
; GP_HBV_Instand_03_22_EN
pdf, [1.06 MB]
; GP_HBV_QCMD_08_21_EN
pdf, [189.09 kB]
; GP_HBV_Instand_03_21_EN
pdf, [1.02 MB]
Choose all

Files are available only for registered users.

Declaration of Verification

; Declaration of Verification of the kits with medical devices
pdf, [2.53 MB]

Instructions for Use & Advisory Notice

Instructions for Use are for informative purposes only

; GP_HBV_Advisory_Notice_05_23
pdf, [444.35 kB]
; GP_HBV_Instructions for Use_EN
pdf, [503.59 kB]
; GP_HBV_Instructions_for_Use_ES
pdf, [368.28 kB]
; GP_HBV_Instructions_for_Use_FR
pdf, [369.94 kB]
; GP_HBV_Instructions_for_Use_IT
pdf, [366.57 kB]
; GP_Quantitative PCR kits_Advisory Notice_04_2023_EN
pdf, [724.54 kB]

MSDS

; GP_HBV_Safety_Data_Sheet_EN
pdf, [278.5 kB]

PCR Template

; 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]
; GP_HBV_Mic
micassay, [13.84 kB]
; GP_HBV_template_AmpliLAB
tlpi, [3.04 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]