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GeneProof Team
Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products
Product name | Catalog no. | Technology | Packaging |
GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit | HHV8/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Human Herpesvirus 8 (HHV-8) PCR Kit | HHV8/ISEX/100 | real-time PCR | 100 reactions |
Indication | in vitro diagnostic medical device |
Regulatory Status | CE IVD |
Intended User | For professional use in laboratories with trained staff |
Technology | real-time PCR |
Type of Analysis | Qualitative and quantitative |
Target Sequence |
ORF26 gene, ORF73 gene |
Analytical Specificity |
0.47 cp/µl (performed on positive control) |
Diagnostic Specificity |
92.86 % (CI95%: 64.17 % - 99.63 %) |
Diagnostic Sensitivity | 100.00 % (CI95%: 69.87 % - 100.00 %) |
Positive Predictive Value | 92.31 % (CI95%: 62.09 % - 99.60 %) |
Negative Predictive Value | 100.00 % (CI95%: 71.65 % - 100.00 %) |
Linear Range |
109 – 104 cp/ml with precision of ± 0.5 log |
Dynamic Range | 109 – LoD cp/ml (LoD varying according to the extraction and material used) |
Precision - Repeatability | • Intra-assay SD of log concentration = 0.063 (CI95%: 0.050 – 0.084) |
Precision - Reproducibility |
• Inter-assay SD of log concentration = 0.078 (CI95%: 0.049 – 0.191) • Inter-lot SD of log concentration = 0.088 (CI95%: 0.055 – 0.216) • Total SD of log concentration = 0.084 (CI95%: 0.052 – 0.205) |
Reporting Units |
cp/μl |
Extraction/Inhibition Control |
PCR inhibition and DNA extraction efficiency control by Internal Standard (IS) |
Validated Specimen |
CSF, plasma, saliva, whole blood (EDTA) |
Storage |
-20 ± 5 °C |
Validated Extraction Method |
croBEE 201A Nucleic Acid Extraction System GeneProof PathogenFree DNA Isolation Kit |
Validated Instruments |
croBEE Real-Time PCR System |
Required Detection Channels |
FAM (HHV-8), HEX/JOE/VIC (IS) |
External Quality Assessment | regularly tested by in Instand e.V. External Quality Assessment Panels – results at www.geneproof.com |
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