Leírás
PRODUCT ADVANTAGES
DUAL TARGET DETECTION
- Dual targeting prevents a detection failure caused by the occurrence of mutations
UNIVERSAL PCR PROFILE
- Easily combinable with other PCR kits from the Immunocompromised / Transplanted panel, Sexually Transmitted Infection and Neuroinfections
- Simplifies laboratory workflow
QUALITATIVE AND QUANTITATIVE DETECTION
- Unique possibility to quantify viral load
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD 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 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 Tracebility | not applicable |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| 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 |
| Validated 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™ 3 / 5 Real-Time PCR System Rotor-Gene 3000 / 6000 / Q SLAN® Real-Time PCR System Montania 4896 Real-Time PCR termocykler 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 – results at www.geneproof.com |
| Certification | CE IVD |
