Welcome to GeneProof website!

It is great to see you here. To see all contents of the website, please register or restore your access.
We believe you will come back gladly.

GeneProof Team

 

User account
Forgot your password?
Searching

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

CE IVD

PRODUCT ADVANTAGES

 

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 (97.62%)

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

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/100 real-time PCR 100 reactions

Product Leaflet

Product Leaflet

; GP_STI_Panel_Leaflet_EN
pdf, [1.42 MB]
; GP_HSV_Leaflet_EN
pdf, [230.5 kB]
Choose all

EQA Panels

EQA results

; GP_STI II_QCMD_11_2022_EN
pdf, [228.53 kB]
; GP_HSV_QCMD_9_2022_EN
pdf, [150.43 kB]
; GP_HSV_croBEE_QCMD_9_2022_EN
pdf, [149.74 kB]
; GP_HSV_QCMD_05_22_EN_02
pdf, [151.42 kB]
; GP_HSV_QCMD_05_22_EN_01
pdf, [151.26 kB]
; GP_HSV_QCMD_10_21_EN_02
pdf, [125.97 kB]
; GP_HSV_QCMD_10_21_EN_01
pdf, [126.08 kB]
; GP_HSV_QCMD_06_21_EN_02
pdf, [145.58 kB]
; GP_HSV_QCMD_06_21_EN_01
pdf, [145.45 kB]
; GP_HSV_Instand_06_21_EN
pdf, [1 MB]
Choose all

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
Technology real-time PCR
Type of Analysis qualitative and quantitative
Target Sequence gene encoding B glycoprotein (gB)
Analytical Specificity

Herpes simplex virus type 1 (HSV-1), 100 %
Herpes simplex virus type 2 (HSV-2), 100 %

Analytical Sensitivity (LoD)
Sample processing Type Plasma Serum Whole blood CSV
GeneProof PathogenFree DNA Isolation Kit HSV-1 122,1 cp/ml 196,2 cp/ml 272,6 cp/ml 82,8 cp/ml
GeneProof PathogenFree DNA Isolation Kit HSV-2 194,5 cp/ml 70,0 cp/ml 160,9 cp/ml 60,2 cp/ml
croBEE 201A Nucleic Acid Extraction Kit HSV-1 673,7 cp/ml 302,6 cp/ml 219,2 cp/ml 642,7 cp/ml
croBEE 201A Nucleic Acid Extraction Kit HSV-2 440,4 cp/ml 308,4 cp/ml 219,6 cp/ml 432,6 cp/ml
Diagnostic Specificity 97.62 % (CI95%: 93.63 % – 99.23 %)
Diagnostic Sensitivity 100.00 % (CI95%: 98.24 % – 100.00 %)
Positive Predictive Value 98.53 % (CI95%: 96.04 % – 99.53 %)
Negative Predictive Value 100.00 % (CI95%: 97.15 % – 100.00 %)
Linear Range

1010 – 102 cp/ml with precision of ± 0.5 log (GeneProof PathogenFree DNA Isolation Kit)

1010 – 102.5 cp/ml with precision of ± 0.5 log (croBEE 201A Nucleic Acid Extraction Kit)

Dynamic Range

1010 – LoD cp/ml (LoD varying according to the extraction, material and channel used)

Reporting Units

cp/ml

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 by Internal Standard (IS)

Validated Specimen CSF, plasma, serum, urine, swab (genital, vesicular), whole blood (EDTA)
Storage -20 ± 5 °C
Validated Extraction Method

croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit

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
QuantStudio™ 5 Real-Time PCR System
Rotor-Gene 3000 / Q
SLAN® Real-Time PCR System

Required Detection Channels

FAM (HSV-1), HEX/JOE/VIC (IS), Cy5 (HSV-2)

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

Instructions for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_HSV12_Advisory_Notice_04_22
pdf, [994.14 kB]
; GP_HSV_Advisory Notice_1_23_EN
pdf, [413.12 kB]
; GP_HSV_Instruction_for_Use_EN
pdf, [196.78 kB]
; GP_HSV_Instruction_for_Use_ES
pdf, [199.09 kB]
; GP_HSV_Instruction_for_Use_FR
pdf, [168.08 kB]
; GP_HSV_Instruction_for_Use_IT
pdf, [292.92 kB]

Declaration of Conformity

; GP_HSV_Declaration_of_Conformity_EN
pdf, [617.95 kB]

MSDS

; GP_HSV_Safety_Data_Sheet_EN
pdf, [276.7 kB]

Publications

; GP_IT_Publications_08_2022_EN
pdf, [276.77 kB]
; GP_STI_publications_08_22_EN
pdf, [204.33 kB]

PCR Template

; GP_DNA_3CH_2CH_ABI7500
edt, [10.72 kB]
; GP_DNA_3CH_2CH_AriaMx
amxt, [3.61 kB]
; GP_DNA_3CH_2CH_croBEE
fqt, [4.91 kB]
; GP_DNA_3CH_2CH_QS5
edt, [8.14 kB]
; GP_DNA_BioRad
prcl, [1.33 kB]
; GP_HSV_Mic
micassay, [17.18 kB]
; RG_DNA_2CH_3CH_4CH
ret, [13.83 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]
; 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, [1.81 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]
Files are available only for registered users.

News

PCR Testing for the "Tripledemic"

GeneProof offers a unique PCR testing solution that provides differential diagnostics of many pathogens

GeneProof is IVDR Certified

Our products’ quality, safety, and performance are fully compliant with the new rules for in vitro…