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  • GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR)
  • GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR) - Picture 2
  • GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR) - Picture 3
  • GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR) - Picture 4
  • GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR) - Picture 5
  • GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR)
  • GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR) - Picture 2
  • GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR) - Picture 3
  • GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR) - Picture 4
  • GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR) - Picture 5

GeneProof® Herpes Simplex Virus (HSV-1/2) PCR Kit - (IVDR)

Manufacturer:GeneProof
Country:Czech Republic

Specialist consultation

+38 (067) 880 44 83

Details

MORE INFORMATION FROM ONE REACTION
PCR kit detects and distinguishes Herpes Simplex Virus 1 and Herpes Simplex Virus 2 in a single reaction tube

 

EXCELLENT QUALITY
The highest possible diagnostic sensitivity (100.00%) and diagnostic specificity (96.08%)

 

SIMPLE LABORATORY WORKFLOW
Easily combinable with other GeneProof PCR kits in one workflow

 

EASY-TO-USE CONCEPT
Single tube Ready-to-Use Master Mix contains all components for PCR amplification
No additional PCR reagents pipetting necessary

 

CONTAMINATION PREVENTION
Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible carryover contamination
 
COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES
CE IVD CERTIFIED DIAGNOSTIC TEST

 

HSV/GP/025 - 25 tests
HSV/GP/100 - 100 tests

 

Characteristics

INDICATIONin vitro diagnostic medical device
TECHNOLOGYReal-time PCR
TARGET SEQUENCEGene encoding B glycoprotein (gB)
DIAGNOSTIC SPECIFICITY96.08 % (CI95%: 89.69 % – 98.74 %)
POSITIVE PREDICTIVE VALUE98.65 % (CI95%: 96.34 % – 99.57 %)
DYNAMIC RANGE10*10 – LoD cp/ml (LoD varying according to the extraction, material and channel used)
CONVERSION FACTORNot applicable
EXTRACTION/INHIBITION CONTROLPCR inhibition and DNA extraction efficiency control by Internal Control (IC)
STORAGE(-20 ± 5) °C
APPLIED INSTRUMENTS▪ croBEE Real-Time PCR System ▪ AMPLilab Real-Time PCR System ▪ Applied Biosystems 7500 Real-Time PCR System ▪ AriaMx Real-Time PCR System ▪ BioQuant-96 Real-Time PCR System ▪ CFX96/ Dx Real-Time PCR Detection System ▪ CFX Opus 96 Real-Time PCR System ▪ Gentier 96E/96R Real-Time PCR System ▪ LightCycler® 480 ▪ LineGene 9600 / 9600 Plus ▪ Mic qPCR Cycler ▪ uantStudio™ 5 Real-Time PCR System ▪ Rotor-Gene 3000 / Q ▪ SLAN® Real-Time PCR System
EXTERNAL QUALITY ASSESSMENTRegularly tested in QCMD and Instand e.V. External Quality Assessment Panels – results at www.geneproof.com
REGULATORY STATUSCE IVD / Regulation (EU) 2017/746
TYPE OF ANALYSISQualitative and quantitative
ANALYTICAL SPECIFICITYHerpes simplex virus type 1 (HSV-1), 100 %, Herpes simplex virus type 2 (HSV-2), 100 %
DIAGNOSTIC SENSITIVITY100 % (CI95%: 98.38 % – 100 %)
NEGATIVE PREDICTIVE VALUE100 % (CI95%: 95.30 % – 100 %)
REPORTING UNITScp/ml
METROLOGICAL TRACEABILITYAcroMetrix HSV-1 Plasma Panel (AcroMetrix HSV-1) | AcroMetrix HSV-2 Plasma Panel (AcroMetrix HSV-2)
VALIDATED SPECIMENDNA extracted from CSF, plasma, serum, urine, swab (genital, vesicular), whole blood (EDTA)
VALIDATED EXTRACTION METHOD▪ croBEE 201A Nucleic Acid Extraction Kit ▪ myCROBE/croBEE 2.0 Universal Extraction Kit ▪ GeneProof PathogenFree DNA Isolation Kit
DETECTION CHANNELSFAM (HSV-1), HEX/JOE/VIC (IC), Cy5 (HSV-2)

Service and Warranty

Contact phone+38 (067) 133 05 52
E-mail:service@empirica.healthcare

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