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GeneProof Team
Product name | Catalog no. | Technology | Packaging |
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit | HSV/ISEX/025 | real-time PCR | 25 reactions |
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit | HSV/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 | gene encoding B glycoprotein (gB) | ||||||||||||||||||||||||||||||
Analytical Specificity |
Herpes simplex virus type 1 (HSV-1), 100 % |
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Analytical Sensitivity (LoD) |
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Diagnostic Specificity | 97.62 % (CI95%: 93.63 % – 99.23 %) | ||||||||||||||||||||||||||||||
Diagnostic Sensitivity | 100.00 % (CI95%: 98.24 % – 100.00 %) | ||||||||||||||||||||||||||||||
Positive Predictive Value | 98.53 % (CI95%: 96.04 % – 99.53 %) | ||||||||||||||||||||||||||||||
Negative Predictive Value | 100.00 % (CI95%: 97.15 % – 100.00 %) | ||||||||||||||||||||||||||||||
Linear Range |
1010 – 102 cp/ml with precision of ± 0.5 log (GeneProof PathogenFree DNA Isolation Kit) 1010 – 102.5 cp/ml with precision of ± 0.5 log (croBEE 201A Nucleic Acid Extraction Kit) |
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Dynamic Range |
1010 – LoD cp/ml (LoD varying according to the extraction, material and channel used) |
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Reporting Units |
cp/ml |
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Metrological Traceability |
AcroMetrixTM HSV-1 Plasma Panel (AcroMetrix HSV-1) |
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Extraction/Inhibition Control |
PCR inhibition and DNA extraction efficiency control by Internal Standard (IS) |
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Validated Specimen | CSF, plasma, serum, urine, swab (genital, vesicular), whole blood (EDTA) | ||||||||||||||||||||||||||||||
Storage | -20 ± 5 °C | ||||||||||||||||||||||||||||||
Validated Extraction Method |
croBEE 201A Nucleic Acid Extraction Kit |
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Instruments |
croBEE Real-Time PCR System |
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Required Detection Channels |
FAM (HSV-1), HEX/JOE/VIC (IS), Cy5 (HSV-2) |
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External Quality Assessment | regularly tested by QCMD and Instand e.V. External Quality Assessment panels - results at www.geneproof.com |
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GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens
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