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GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit

CE IVD

PRODUCT ADVANTAGES

 

DUAL TARGET DETECTION

  • Dual targeting prevents a detection failure caused by the occurrence of mutations

UNIVERSAL PCR PROFILE

  • Easily combinable with other PCR kits from the Immunocompromised / Transplanted panel, Sexually Transmitted Infection and Neuroinfections
  • Simplifies laboratory workflow

QUALITATIVE AND QUANTITATIVE DETECTION

  • Unique possibility to quantify viral load

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible 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 Herpesvirus 8 (HHV-8) PCR Kit HHV8/ISEX/025 real-time PCR 25 reactions
GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit HHV8/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_HHV8_Instand_03_21_EN
pdf, [1.02 MB]
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 and quantitative
Target Sequence

ORF26 gene, ORF73 gene

Analytical Specificity

0.47 cp/µl (performed on positive control)

Diagnostic Specificity

92.86 % (CI95%: 64.17 % - 99.63 %)

Diagnostic Sensitivity 100.00 % (CI95%: 69.87 % - 100.00 %)
Positive Predictive Value 92.31 % (CI95%: 62.09 % - 99.60 %)
Negative Predictive Value 100.00 % (CI95%: 71.65 % - 100.00 %)
Linear Range

109 – 104 cp/ml with precision of ± 0.5 log

Dynamic Range 109 – LoD cp/ml (LoD varying according to the extraction and material used)
Precision - Repeatability • Intra-assay SD of log concentration = 0.063 (CI95%: 0.050 – 0.084)
Precision - Reproducibility

• Inter-assay SD of log concentration = 0.078 (CI95%: 0.049 – 0.191)

• Inter-lot SD of log concentration = 0.088 (CI95%: 0.055 – 0.216)

• Total SD of log concentration = 0.084 (CI95%: 0.052 – 0.205)

Reporting Units

cp/μl

Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control by Internal Standard (IS)

Validated Specimen

CSF, plasma, saliva, whole blood (EDTA)

Storage

-20 ± 5 °C

Validated Extraction Method

croBEE 201A Nucleic Acid Extraction System

GeneProof PathogenFree DNA Isolation Kit

Validated 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® 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / Q
SLAN® Real-Time PCR System
Montania 4896 Real-Time PCR termocykler
StepOne™ / StepOnePlus™ Real-Time PCR System

Required Detection Channels

FAM (HHV-8), HEX/JOE/VIC (IS)

External Quality Assessment regularly tested by in 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_HHV8_Advisory_Notice_04_22
pdf, [989.9 kB]
GP_HHV8_Instruction_for_Use_EN
pdf, [335.85 kB]

Declaration of Conformity

GP_HHV-8_Declaration of Conformity_EN
pdf, [577.57 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 - 8_Mic
micassay, [22.21 kB]
RG_DNA_2CH_3CH_4CH
ret, [13.83 kB]

Product Leaflet

GP_HHV8_Leaflet_EN
pdf, [133.44 kB]
GP_IT_Panel_Leaflet_EN
pdf, [275.02 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 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.