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

CE IVD

HHV6/7 new product

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

 

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/µl

Metrological Traceability

NIBSC HHV6B 15/266

Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control (Internal standard)

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, Cy5

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

 * Validated instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit HHV/ISEX/025 real-time PCR 25 reactions
GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit HHV/ISEX/050 real-time PCR 50 reactions
GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit HHV/ISEX/100 real-time PCR 100 reactions