GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit
CE IVD
PRODUCT DETAIL
The PCR Kit is designed for detection of Herpes simplex virus type 1 (HSV-1) by the real-time Polymerase Chain Reaction (PCR) method.
The HSV-1 detection consists in amplification of a specific conservative DNA sequence of a single-copy gene encoding the glycoprotein B (gB) and in measurement of fluorescence increase. The HSV-1 presence is indicated by the FAM fluorophore 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 a single-copy gene encoding the glycoprotein B (gB) |
| Specificity | Herpes Simplex Virus type 1 (HSV-1), 100 % |
| Sensitivity (LoD) | reaches up to 122.124 cp/ml with the probability of 95 % (on AcroMetrixTM HSV-1 Plasma Panel using manual extraction GeneProof PahogenFree DNA Isolation Kit) |
| Linear Range | 1010 – 102.5cp/ml with precision of ± 0.5 log
|
| Reporting Units | cp/μl
|
| Metrological Traceability | AcroMetrixTM HSV-1 Plasma Panel (AcroMetrix HSV-1) |
| Extraction/Inhibition Control | PCR inhibition control (ISIN version) PCR inhibition and DNA extraction efficiency control (ISEX version) |
| Validated Specimen | whole blood, plasma, urine, CSF |
| Storage | -20 ± 5 °C |
| Validated Extraction Methods | croBEE NA16 Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
| Validated Instruments | croBEE Real-Time PCR System Applied Biosystems 7300 / 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System LightCycler® 2.0 / 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 StepOne™ / StepOnePlus™ Real-Time PCR System |
| Required Detection Channels | FAM, HEX |
| Quality Control | quality management system is certified in compliance with the requirements of the standard ISO 13485 |
| External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment Panels - for results see www.geneproof.com |
| Certification | CE IVD for in vitro Diagnostics Use |
ORDER INFORMATION
| Product name | Cat. No. | Technology | Package |
| GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit | HSV1/ISEX/025 | real-time PCR | 25 reactions |
| GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit | HSV1/ISEX/050 | real-time PCR | 50 reactions |
| GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit | HSV1/ISEX/100 | real-time PCR | 100 reactions |