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

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

CE IVD

PRODUCT DETAIL

The PCR kit is designed for detection and differentiation of both types of Herpes simplex viruses (HSV-1 and HSV-2) by the real-time Polymerase Chain Reaction (duplex PCR) method.

The HSV detection and differentiation consists in amplification of a specific conservative DNA sequence of a single-copy gene encoding the glycoprotein B (gB) and in measurement of fluorescence increase. The HSV-1 presence is indicated by the FAM fluorophore fluorescence growth and the HSV-2 presence is indicated by the Cy5 fluorophore fluorescence growth. An Internal Standard (IS) is either included in the reaction mix, controlling the possible inhibition of the PCR (ISIN version) or excluded, controlling also the DNA extraction process quality (ISEX version). IS positive amplification is detected in the HEX fluorophore fluorescence channel. The detection kit takes advantage of the "hot start" technology, minimizing non-specific reactions and assuring maximum sensitivity. Ready to Use MasterMix contains uracil DNA glycosylase (UDG), eliminating possible contamination of the PCR with amplification products. The kit is designed for in vitro diagnostics and provides qualitative and quantitative detection.

TECHNICAL SPECIFICATION 

Technology real-time PCR
Type of Analysis qualitative and quantitative
Target Sequence specific conservative DNA sequence of a single-copy gene encoding glycoprotein B (gB)
Specificity Herpes simplex virus type 1 (HSV-1), 100 %

Herpes simplex virus type 2 (HSV-2), 100 %

Sensitivity (LoD) for HSV-1 reaches up to 122.124 cp/ml with the probability of 95 % (on AcroMetrix™ HSV-1 Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)

for HSV-2 reaches up to 194.49 cp/ml with the probability of 95 % (on AcroMetrix™ HSV-2 Plasma Panel using manual extraction GeneProof PathogenFree DNA Isolation Kit)

Linear Range  for HSV-1: 1010 - 102.5 cp/ml with precision of ± 0.5 log

for HSV-2: 1010 - 102.5 cp/ml with precision of ± 0.5 log

Reporting Units cp/μl
Metrological Traceability AcroMetrixTM HSV-1 Plasma Panel (AcroMetrix HSV-1)

AcroMetrixTM HSV-2 Plasma Panel (AcroMetrix HSV-2)

Extraction/Inhibition Control PCR inhibition control (ISIN version)

PCR inhibition and DNA extraction efficiency control (ISEX version)

Validated Specimen whole blood, plasma, urine, CSF
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 7500 Real-Time PCR System
AriaMx Real-Time PCR System
CFX96™ / Dx Real-Time PCR Detection System
LightCycler® 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler

QuantStudio™ 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR SystemRequired Detection ChannelsFAM, HEX, Cy5Quality ControlQuality management system is certified in compliance with the requirements of the standard ISO 13485External Quality Assessmentregularly tested by QCMD and Instand e.V. External Quality Assessment panels - results at www.geneproof.comCertificationCE IVD, for in vitro Diagnostics Use

 

ORDER INFORMATION

Product name Cat. No. Technology Package
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit HSV/ISIN/025 real-time PCR 25 reactions
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit HSV/ISIN/050 real-time PCR 50 reactions
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit HSV/ISIN/100 real-time PCR 100 reactions
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/050 real-time PCR 50 reactions
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit HSV/ISEX/100 real-time PCR 100 reactions

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