GeneProof Human Herpesvirus 6/7 (HHV-6/7) PCR Kit
Kat.: HHV/ISEX/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
A Humán Herpeszvírus 6/7 (HHV-6/7) detektálására alkalmas ‘Ready-to-Use ‘ master mix. A Rep68 feltételezett integrázt kódoló U94 gén specifikus HHV-6A/B DNS-szekvenciáját és a fő kapszidfehérjét kódoló U57 gén specifikus HHV-7 DNS-szekvenciáját célozza. (25 reakció)
Leírás
PRODUCT ADVANTAGES
MORE INFORMATION WITH LESS SAMPLES
- PCR Kit detects both viruses in a single reaction tube
QUANTITATIVE DETECTION OF BOTH VIRUSES
- Precise quantification of the both viruses in two separate detection channels
HIGH SENSITIVITY AND TRACEABILITY
- Sensitivity was established with WHO certified strain
CONTAMINATION ELIMINATION
- Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating 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 HHV-6A/B DNA sequence of U94 gene coding the putative integrase Rep68. Specific HHV-7 DNA sequence of U57 gene coding major capsid protein |
| Analytical Specificity | Human Herpesvirus 6/7 (HHV-6/7), 100 % |
| Analytical Sensitivity (LoD) | reaches up to 152.05 IU/ml with the probability of 95 % (on NIBSC HHV6B 15/266 using manual extraction GeneProof PathogenFree DNA Isolation Kit) reaches up to 304.91 IU/ml with the probability of 95 % (on (NIBSC HHV6B 15/266 using automatic extraction croBEE NA16 Nucleic Acid Extraction System) |
| Linear Range | 1010 – 102.5 IU/ml with precision of ± 0.5 log (using manual extraction GeneProof PathogenFree DNA Isolation Kit or automatic extractor croBEE NA16 Nucleic Acid Extraction System) |
| Dynamic Range | 1010 – 152.05 IU/ml (using manual extraction GeneProof PathogenFree DNA Isolation Kit) 1010 – 304.91 IU/ml (using automatic extractor croBEE NA16 Nucleic Acid Extraction System) |
| Reporting Units | IU/ml |
| Metrological Traceability | NIBSC HHV6B 15/266 |
| Extraction/Inhibition Control | PCR inhibition and DNA extraction efficiency control |
| Validated Specimen | CSF, plasma, whole blood* * Qualitative PCR DNA test on whole blood is useless for differentiating active from latent HHV-6/7 infection. Almost all healthy individuals have low levels of latent HHV-6 in the whole blood. Therefore, is highly recommended to perform repeated quantification of HHV-6/7 viral loads in the whole blood on consecutive specimens using the same extraction method and quantitative PCR assay for given patient to differentiate active (increasing trend of viral load) from latent (stable or below LoD) HHV-6/7 infection. |
| 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 Plus Mic qPCR Cycler QuantStudio TM 5 Real Time PCR System Rotor-Gene Q SLAN® Real Time PCR System |
| Required Detection Channels | FAM, HEX, Cy5 |
| External Quality Assessment | regularly tested by QCMD External Quality Assessment panels – for results see www.geneproof.com |
| Certification | CE IVD |
