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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 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 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/100 real-time PCR 100 reactions

EQA Panels

EQA results

; GP_HHV67_QCMD_06_22_EN_02
pdf, [223.63 kB]
; GP_HHV6_Instand_03_22_EN
pdf, [1.06 MB]
; GP_Transplatation_QCMD_01_22_EN
pdf, [200.17 kB]
; GP_HHV67_QCMD_06_21_EN_02
pdf, [215.7 kB]
; GP_HHV67_QCMD_06_21_EN_01
pdf, [214.85 kB]
; GP_HHV6_Instand_03_21_EN
pdf, [1.02 MB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD / EC Directive 98/79/EC
Intended User For professional use in laboratories with trained staff
Technologie Real-time PCR
Type of Analysis Qualitative and quantitative
Target Sequence

U94 gene (HHV-6A/B), U57 gene (HHV-7)

Analytical Specificity Human Herpesvirus 6/7 (HHV-6/7), 100 %
Analytical Sensitivity
(LoD with 95% probability)

Sample Processing

Plasma Whole blood CSF
GeneProof PathogenFree DNA Isolation Kit 134.9 IU/ml 169.0 IU/ml 152.3 IU/ml
croBEE 201A Nucleic Acid Extraction Kit 312.9 IU/ml 448.4 IU/ml 793.4 IU/ml
Diagnostic Specificity 97.73 % (CI95%: 92,99 % - 99,41 %)
Diagnostic Sensitivity 98.72 % (CI95%: 92,09 % - 99,93 %)
Positive predictive value 96.25 % (CI95%: 88,68 % - 99,03 %)
Negative predictive value 99.23 % (CI95%: 95,16 % - 99,96 %)
Linear Range 108 – 102.5 IU/ml with precision of ± 0.5 log
Dynamic Range

108 – LoD IU/ml (LoD varying according to the extraction and material used)

Trueness
(of expected concentration)
0,005 log (CI95%: -0,05 – 0,06) using manual extraction GeneProof PathogenFree DNA Isolation Kit
-0,002 log (CI95%: -0,08 – 0,07) using automatic extraction croBEE 201A Nucleic Acid Extraction Kit
Reporting Units IU/ml
Conversion Factor IU = 0.6 cp / 1 cp = 1.8 IU
Metrological Traceability NIBSC HHV6B 15/266
Extraction/Inhibition Control PCR inhibition and DNA extraction efficiency control by Internal Standard (IS)
Validated Specimen

CSF, plasma, whole blood (EDTA)*

Storage -20 ± 5 °C
Validated Extraction Methods croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
Applied Instruments

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

Detection Channels FAM (HHV-6), HEX/JOE/VIC (IS), Cy5* (HHV-7)
External Quality Assessment

Regularly tested in QCMD and INSTAND e.V. External Quality Assessment Panels – results at www.geneproof.com

*NOTE: Due to the availability of international reference standard only for HHV-6, it is possible to monitor HHV-7 in cp/ml reporting units.

 

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.6 MB]
; GP_Advisory Notice_ADV-EBV-HHV67-B19-VZV_EN
pdf, [508.26 kB]
; GP_HHV_Advisory Notice_EN
pdf, [932.15 kB]
; GP_HHV_Instruction for Use_EN
pdf, [354.18 kB]
; GP_HHV_Instruction_for_Use_ES
pdf, [197.13 kB]
; GP_HHV_Instruction_for_Use_IT
pdf, [170.72 kB]

Declaration of Conformity

; GP_HHV_Declaration_of_Conformity_EN
pdf, [569.71 kB]

MSDS

; GP_HHV67_Safety_Data_Sheet_EN
pdf, [276.98 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_HHV 6_7_Mic
micassay, [27.7 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

; GP_HHV_Leaflet_EN
pdf, [127.85 kB]
; GP_IT_Panel_Leaflet_EN
pdf, [275.02 kB]
; GP_Transplatation_QCMD_01_22_EN
pdf, [200.17 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]
; 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]
; SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
; ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]
Files are available only for registered users.