GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit
Kat.: HSV/ISEX/100
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
Az 1-es típusú Herpes Simplex (HSV-1) és a 2-es típusú Herpes Simplex (HSV-2) virusok detektálására alkalmas master mix. A glycoprotein B-t (gB) kódoló gén specifikus, egyetlen kópiájú, konzervatív DNS szekvenciát célozza. (25 reakció)
Leírás
MORE INFORMATION WITH LESS SAMPLES
- Detects and distinguishes Herpes Simplex Virus 1 and Herpes Simplex Virus 2 in a single reaction tube
UNIVERSAL PCR PROFILE
- Easily combinable with other PCR kits from the Immunocompromised / Transplanted, Neuroinfections and Sexually Transmitted Infections groups
- Simplifies laboratory workflow
EXCELLENT EQA PANEL RESULTS
- The highest possible diagnostic sensitivity (100.00 %) and diagnostic specificity (99.25 %) confirmed by analysis of EQA panel reports from 2009 to present (including infrequently detected rare samples with very low concentrations)
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products
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 glycoprotein B (gB) |
| Analytical Specificity | Herpes simplex virus type 1 (HSV-1), 100 % Herpes simplex virus type 2 (HSV-2), 100 % |
| Analytical Sensitivity (LoD) | for HSV-1 reaches up to 122.124 cp/ml with the probability of 95 % (on AcroMetrix™ HSV-1 Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit) for HSV-2 reaches up to 194.49 cp/ml with the probability of 95 % (on AcroMetrix™ HSV-2 Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit) |
| Diagnostic Specificity | 99.24 % (CI95%: 95.23 % – 99.96 %) |
| Diagnostic Sensitivity | 100 % (CI95%: 97.08 % – 100 %) |
| Linear Range | for HSV-1: 1010 – 102.5 cp/ml with precision of ± 0.5 log for HSV-2: 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) AcroMetrixTM HSV-2 Plasma Panel (AcroMetrix HSV-2) |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | whole blood, plasma, urine, CSF |
| 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 7500 Real-Time PCR System AriaMx Real-Time PCR System CFX96™ / Dx Real-Time PCR Detection System LightCycler® 480 LineGene 9600 / 9600 Plus Mic qPCR Cycler Rotor-Gene 3000 / Q SLAN® Real-Time PCR System |
| Required Detection Channels | FAM, HEX, Cy5 |
| External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment panels – results at www.geneproof.com |
| Certification | CE IVD |
