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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

EQA Panels

EQA results

; 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 7300 / 7500 Real-Time PCR System
AriaMx Real-Time PCR System
BioQuant-96 Real-Time PCR System
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
Gentier 96E/96R Real-Time PCR System
LightCycler® 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 / 5 Real-Time PCR System
Rotor-Gene 3000 / 6000 / 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

Documentation

Instruction 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_EN
pdf, [906.08 kB]
; GP_HSV_Instruction_for_Use_EN
pdf, [342.85 kB]
; GP_HSV_Instruction_for_Use_ES
pdf, [352.97 kB]
; GP_HSV_Instruction_for_Use_FR
pdf, [383.66 kB]
; GP_HSV_Instruction_for_Use_IT
pdf, [349.36 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

; STI_publications
pdf, [254.48 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]

Product Leaflet

; GP_HSV_Leaflet_EN
pdf, [230.5 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.

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