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

CE IVD

PRODUCT ADVANTAGES

 

MORE INFORMATION WITH LESS SAMPLES

  • Detects and distinguishes Herpes Simplex Virus 1 and Herpes Simplex Virus 2 in a single reaction tube

UNIVERSAL PCR PROFILE

  • Easily combinable with other PCR kits from the Immunocompromised / Transplanted, Neuroinfections and Sexually Transmitted Infections groups 
  • Simplifies laboratory workflow

EXCELLENT EQA PANEL RESULTS

  • The highest possible diagnostic sensitivity (100.00 %) and diagnostic specificity (99.25 %) confirmed by analysis of EQA panel reports from 2009 to present (including infrequently detected rare samples with very low concentrations)

CONTAMINATION ELIMINATION

  • Ready-to-Use Master Mix contains Uracil-DNA glycosylase (UNG) and dUTPs eliminating possible contamination with amplification products

 

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)
Analytical Specificity

Herpes simplex virus type 1 (HSV-1), 100 %

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

Analytical 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)

Diagnostic Specifity

99.24 % (CI95% : 95.23 % – 99.96 %)

Diagnostic Sensitivity

100 % (CI95% : 97.08 % – 100 %)

Linear Range 

1010 - 102.5 cp/ml with precision of ± 0.5 log

Dynamic Range

HSV-1: 1010 – 122.124 cp/ml
HSV-2: 1010 – 194.49 cp/ml

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

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 System

Required Detection Channels

FAM, HEX, Cy5

External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment panels - results at www.geneproof.com
Certification CE IVD

 *Validated Instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
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