GeneProof Herpes Simplex Virus 1 (HSV-1) PCR Kit
Kat.: HSV1/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
Az 1-es típusú Herpes Simplex (HSV-1) virus detektálására alkalmas master mix. A glycoprotein B-t (gB) kódoló gén specifikus, egyetlen kópiájú, konzervatív DNS szekvenciát célozza. (25 reakció)
Leírás
PRODUCT ADVANTAGES
EXCELLENT EQA PANEL RESULTS
- No penalty points for qualitative and quantitative detection since 2011 in 13 consequential EQA panels of INSTAND e. V. and QCMD
UNIVERSAL PCR PROFILE
- Easily combinable with other PCR kits from the Immunocompromised / Transplanted, Neuroinfections and Sexually Transmitted Infections groups
- Simplifies laboratory workflow
CONTAMINATION PREVENTION
- Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating contamination with amplification products
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CERTIFIED DIAGNOSTIC TEST
Technical specification
| Indication | in vitro diagnostic medical device |
| Intended User | For professional use in laboratories with trained staff |
| 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 – 102.5 cp/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 PCR inhibition and DNA extraction efficiency control |
| 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 |
| 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 |
