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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 TransmittedInfections 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

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

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/050 real-time PCR 50 reactions
GeneProof Herpes Simplex Virus (HSV-1/2) PCR Kit HSV/ISEX/100 real-time PCR 100 reactions

EQA Panels

EQA results

GP_ HSV_QCMD_2020_EN
pdf, [135.27 kB]
GP_HSV_QCMD_2018_EN
pdf, [171.34 kB]
GP_HSV_QCMD_C2.2018_EN
pdf, [164.59 kB]
GP_HSV_QCMD_C2.2019_EN
pdf, [164.59 kB]
GP_HSV_QCMD_croBEE_2019_EN
pdf, [145.3 kB]
GP_HSV_QCMD_manual_2019_EN
pdf, [145.41 kB]
GP_Instand_06.2018_EN
pdf, [1.36 MB]
GP_Instand_06.2019_EN
pdf, [340.8 kB]
Choose all

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 Specificity 99.24 % (CI95%: 95.23 % – 99.96 %)
Diagnostic Sensitivity 100 % (CI95%: 97.08 % – 100 %)
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 and DNA extraction efficiency control

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
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

 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.45 MB]
GP_HSV_Advisory Notice_EN_CZ
pdf, [219.1 kB]
GP_HSV_Instruction for Use_EN
pdf, [1.09 MB]

Declaration of Conformity

GP_HSV_Declaration of Conformity_EN
pdf, [324.04 kB]

MSDS

GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

AriaMx Real-Time PCR System_EN
pdf, [2.31 MB]
Bio-Rad CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [1.43 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_EN
pdf, [2.33 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]
ThermoFisher ABI 7500/7500 Fast Real-Time PCR System_EN
pdf, [4.2 MB]

Product Leaflet

GP_HSV_Leaflet_EN
pdf, [208.93 kB]

PCR Template

GP_HSV_Mic_1
micassay, [17.18 kB]
Files are available only for registered users.

Order

+420 543 211 679
sales@geneproof.com


Technical Support 

Send request
+420 730 176 222
support@geneproof.com


FAQ


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