GeneProof Human Herpes Virus 8 (HHV-8) PCR Kit
CE IVD
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 – 103 cp/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 |
| 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 |