GeneProof Human Herpes Virus 8 (HHV-8) PCR Kit

CE IVD

HHV8

PRODUCT DETAIL

The PCR kit is designed for Human herpesvirus 8 (HHV-8) detection by the real-time Polymerase Chain Reaction (PCR) method.

The HHV-8 detection consists in amplification of the specific conservative DNA sequence of the ORF26 gene coding the minor capsid protein (mCP) and ORF73 gene coding the latency-associated nuclear antigen (LANA) and in measurement of fluorencence increase. The HHV-8 presence is indicated by FAM fluorophor fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil-DNA-glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

 

 

TECHNICAL SPECIFICATION 

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

specific conservative DNA sequence of the ORF26 gene encoding the minor capsid protein (mCP)
specific conservative DNA sequence of the ORF73 gene encoding the latency-associated nuclear antigen (LANA)

Analytical Specificity

Human herpesvirus 8, 100%

Analytical Sensitivity (LoD)

reaches up to 2.225 cp/µl with the probability of 95%

Linear Range

109 – 10cp/ml with precision of ± 0.5 log

Reporting Units

cp/μl

Conversion Factor

not applicable

Metrological Traceability

not applicable

Extraction/Inhibition Control

PCR inhibition control (ISIN version)

PCR inhibition and DNA extraction efficiency control (ISEXversion)

Validated Specimen

cerebrospinal fluid (CSF), plasma, saliva, whole blood

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 7300 / 7500 Real-Time PCR System

CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System

LightCycler® 480

LineGene 9600 / 9600 Plus

Mic qPCR Cycler

QuantStudio™ 5 Real-Time PCR System

Rotor-Gene 3000 / 6000 / Q

SLAN® Real-Time PCR System
StepOne™ / StepOnePlus™ Real-Time PCR System

Required Detection Channels

FAM, HEX

External Quality Assessment

quality management system is certified in compliance with the requirements of the standard ISO 13485

Regulatory Status CE IVD for in vitro diagnostics 

* Validated Instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof Human Herpes Virus 8 (HHV-8) PCR Kit HHV8/ISIN/025 real-time PCR 25 reactions
GeneProof Human Herpes Virus 8 (HHV-8) PCR Kit HHV8/ISIN/050 real-time PCR 50 reactions
GeneProof Human Herpes Virus 8 (HHV-8) PCR Kit HHV8/ISIN/100 real-time PCR 100 reactions
GeneProof Human Herpes Virus 8 (HHV-8) PCR Kit HHV8/ISEX/025 real-time PCR 25 reactions
GeneProof Human Herpes Virus 8 (HHV-8) PCR Kit HHV8/ISEX/050 real-time PCR 50 reactions
GeneProof Human Herpes Virus 8 (HHV-8) PCR Kit HHV8/ISEX/100 real-time PCR 100 reactions