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GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

MORE INFORMATION WITH LESS SAMPLES

  • PCR Kit detects both viruses in a single reaction tube

QUANTITATIVE DETECTION OF BOTH VIRUSES

  • Precise quantification of the both viruses in two separate detection channels

HIGH SENSITIVITY AND TRACEABILITY

  • Sensitivity was established with WHO certified strain

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof Human Herpes Virus 6/7 (HHV-6/7) PCR Kit HHV/ISEX/025 real-time PCR 25 reactions
GeneProof Human Herpes Virus 6/7 (HHV-6/7) PCR Kit HHV/ISEX/050 real-time PCR 50 reactions
GeneProof Human Herpes Virus 6/7 (HHV-6/7) PCR Kit HHV/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_HHV_QCMD_2019_EN
pdf, [207.48 kB]
Choose all

Technical specification

Technology real-time PCR
Type of Analysis qualitative and quantitative
Target Sequence

Specific HHV-6A/B DNA sequence of U94 gene coding the putative integrase Rep68.
Specific HHV-7 DNA sequence of U57 gene coding major capsid protein

Analytical Specificity

Human Herpesvirus 6/7 (HHV-6/7), 100 %

Analytical Sensitivity (LoD)

reaches up to 152.05 IU/ml with the probability of 95 % (on NIBSC HHV6B 15/266 using manual extraction
GeneProof PathogenFree DNA Isolation Kit)
reaches up to 304.91 IU/ml with the probability of 95 % (on (NIBSC HHV6B 15/266 using automatic extraction
croBEE NA16 Nucleic Acid Extraction System)

Linear Range 1010 – 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation
Kit or automatic extractor croBEE NA16 Nucleic Acid Extraction System)
Dynamic Range 1010 – 152.05 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit)
1010 – 304.91 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System)
Reporting Units

IU/ml

Metrological Traceability

NIBSC HHV6B 15/266

Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control 

Validated Specimen

CSF, plasma, whole blood*
* Qualitative PCR DNA test on whole blood is useless for differentiating active from latent HHV-6/7 infection.
Almost all healthy individuals have low levels of latent HHV-6 in the whole blood. Therefore, is highly
recommended to perform repeated quantification of HHV-6/7 viral loads in the whole blood on consecutive
specimens using the same extraction method and quantitative PCR assay for given patient to differentiate
active (increasing trend of viral load) from latent (stable or below LoD) HHV-6/7 infection.

Storage

-20 ± 5 °C

Validated Extraction Method

croBEE NA16 Nucleic Acid Extraction System
GeneProof PathogenFree DNA Isolation Kit

Instruments

croBEE Real-Time PCR System*
Applied Biosystems 7500 Real-Time PCR System
CFX96™/ Dx Real-Time PCR Detection System
LightCycler 480
LineGene 9600 Plus
Mic qPCR Cycler

Required Detection Channels

FAM, HEX, Texas Red, Cy5

External Quality Assessment regularly tested by QCMD External Quality Assessment panels - for results see www.geneproof.com
Certification CE IVD

* Validated instruments

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_HHV_Instruction for Use_CZ
pdf, [125.86 kB]
GP_HHV_Instruction for Use_EN
pdf, [122.04 kB]

Declaration of Conformity

GP_HHV_Declaration of Conformity_CZ
pdf, [256.73 kB]
GP_HHV_Declaration of Conformity_EN
pdf, [273.25 kB]

MSDS

GP_Safety Data Sheet_CZ
pdf, [134.4 kB]
GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_CZ
pdf, [2.13 MB]
Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_EN
pdf, [2.03 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_CZ
pdf, [3.97 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_EN
pdf, [4.04 MB]
AriaMx Real-Time PCR System_CZ
pdf, [2.17 MB]
AriaMx Real-Time PCR System_EN
pdf, [2.14 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_CZ
pdf, [2.37 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [2.2 MB]
croBEE Real-Time PCR System_CZ
pdf, [6.09 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 480/480 Instrument II_CZ
pdf, [2.3 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_CZ
pdf, [4.66 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_CZ
pdf, [2.7 MB]
Mic qPCR Cycler_EN
pdf, [2.6 MB]
QuantStudio 3/5 Real-Time PCR System_CZ
pdf, [2.31 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
SLAN Real-Time PCR System_CZ
pdf, [1.59 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]

Product Leaflet

GP_HHV_Leaflet_EN
pdf, [166.04 kB]
Files are available only for registered users.