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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]
GP_SZU Certificate 2019_CZ
pdf, [621.64 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 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
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System

Required Detection Channels

FAM, HEX, Cy5

Quality Control Quality management system is certified in compliance with the requirements of the standard ISO 13485
External Quality Assessment regularly tested by QCMD and Instand e.V. External Quality Assessment panels results at www.geneproof.com
Certification CE IVD

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_HSV_Advisory Notice_EN_CZ
pdf, [219.1 kB]
GP_HSV_Instruction for Use_CZ
pdf, [1.09 MB]
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_CZ
pdf, [134.4 kB]
GP_Safety Data Sheet_EN
pdf, [148.84 kB]

Manual

Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_CZ
pdf, [2.13 MB]
Applied Biosystems 7300/7500 Real-Time PCR System (SW 1.x.x)_EN
pdf, [2.03 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_CZ
pdf, [3.97 MB]
Applied Biosystems 7500/7500 Fast Real-Time PCR System (SW 2.x.x)_EN
pdf, [4.04 MB]
AriaMx Real-Time PCR System_CZ
pdf, [2.17 MB]
AriaMx Real-Time PCR System_EN
pdf, [2.14 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_CZ
pdf, [2.37 MB]
CFX 96/Connect/Dx Real-Time PCR Detection System_EN
pdf, [2.2 MB]
croBEE Real-Time PCR System_CZ
pdf, [6.09 MB]
croBEE Real-Time PCR System_EN
pdf, [5.9 MB]
LightCycler 480/480 Instrument II_CZ
pdf, [2.3 MB]
LightCycler 480/480 Instrument II_EN
pdf, [2.18 MB]
LineGene 9600_9600Plus_K_CZ
pdf, [4.66 MB]
LineGene 9600_9600Plus_K_EN
pdf, [4.6 MB]
Mic qPCR Cycler_CZ
pdf, [2.7 MB]
Mic qPCR Cycler_EN
pdf, [2.6 MB]
QuantStudio 3/5 Real-Time PCR System_CZ
pdf, [2.31 MB]
QuantStudio 3/5 Real-Time PCR System_EN
pdf, [2.29 MB]
Rotor-Gene_3000_6000_Q_CZ
pdf, [2.25 MB]
Rotor-Gene_3000_6000_Q_EN
pdf, [2.22 MB]
SLAN Real-Time PCR System_CZ
pdf, [1.59 MB]
SLAN Real-Time PCR System_EN
pdf, [1.56 MB]

Product Leaflet

GP_HSV_Leaflet_EN
pdf, [208.93 kB]
GP_STI_GPacks_Leaflet_EN
pdf, [104.02 kB]
Files are available only for registered users.

Order

+420 543 211 679
sales@geneproof.com


Technical Support 

Contact form 
+420 730 176 222
support@geneproof.com


FAQ

 

 

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