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GeneProof Human Papilloma Virus (HPV) Screening PCR Kit

CE IVD New product

PRODUCT ADVANTAGES

 

HIGH SPECIFICITY

  • Unique detection of 24 high-risk HPV types

SELF-SAMPLING OPTION

  • Validation of self-sampling devices Evalyn® Brush (Rovers Medical Devices) and FLOQSwab® (COPAN)
  • ​​​​​​​Supports wide-spreading of HPV screening through simple and comfortable sampling

CONTAMINATION ELIMINATION

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

DIFFERENTIATION OF HIGH-RISK TYPES 16, 18 AND 45

  • HPV16 and HPV18 are responsible for 70% of cervical cancer cases and pre-cancerous cervical lesion
  • HPV45 is the 3rd most prevalent genotype in cases of invasive cervical cancer worldwide (5–6%)
  • ​​​​​​​Enables specific management of patient monitoring and therapy

COMPLIANCE WITH GUIDELINES FOR HPV SCREENING

  • German S3-guidelines “Prevention of cervical cancer” (S3-Leitlinie Prävention des Zervixkarzinoms Langverison 1.0 – Dezember 2017)
  • The clinical and reproducibility criteria of the International Guidelines for HPV tests for use in cervical cancer screening

 

COMPATIBLE WITH A WIDE RANGE OF REAL-TIME PCR DEVICES

CE IVD CERTIFIED DIAGNOSTIC TEST

Order information

Product name Catalog no. Technology Packaging
GeneProof Human Papilloma Virus (HPV) Screening PCR Kit HPVS/GP/025 real-time PCR 25 reactions
GeneProof Human Papilloma Virus (HPV) Screening PCR Kit HPVS/GP/050 real-time PCR 50 reactions
GeneProof Human Papilloma Virus (HPV) Screening PCR Kit HPVS/GP/100 real-time PCR 100 reactions

Technical specification

Technology real-time PCR
Type of Analysis qualitative
Target sequence E1/E2 gene
Analytical Specificity Human Papillomavirus high-risk types 16, 18, 26, 30, 31, 33, 34, 35, 39, 45, 51, 52, 53, 56, 58, 59, 66, 67, 68, 69,
70, 73, 82, 97 with differentiation of 16, 18 and 45 types
Analytical Sensitivity (LoD)

reaches up to 0.745 IU/μl with the probability of 95 %
(on 1st WHO International standard for Human Papillomavirus Type 16 DNA)
reaches up to 1.561 IU/μl with the probability of 95 %
(on 1st WHO International standard for Human Papillomavirus Type 18 DNA)

Diagnostic Specificity 99 % (CI95%: 93.6 % – 99.9 %)
Diagnostic Sensitivity 100% (CI95%: 87.7 % – 100 %)
Extraction/Inhibition Control

PCR inhibition and DNA extraction efficiency control 

Validated Specimen Swab (cervical, vaginal and penile), LBC medium NOVAPREP (Novacyte), SurePath (BD),
Self-sampling device FLOQSwab® (COPAN), Evalyn® Brush (Rovers Medical Devices)
Storage -20 ± 5 °C
Validated Extraction Methods 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
CFX Connect™ / CFX96™ / Dx Real-Time PCR Detection System
LightCycler® 480
LineGene 9600 / 9600 Plus
Mic qPCR Cycler
QuantStudio™ 3 Real-Time PCR System
SLAN® Real-Time PCR System
VERSANT® kPCR Molecular System

Required Detection Channels FAM, HEX, Cy5, Texas Red, Cy5.5
External Quality Assessment Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
Certification CE IVD for in vitro Diagnostics Use

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.4 MB]
GP_HPVS_Instruction for Use_CZ
pdf, [93.34 kB]
GP_HPVS_Instruction for Use_EN
pdf, [65.68 kB]

Declaration of Conformity

GP_HPVS_Declaration of Conformity_CZ
pdf, [308.04 kB]
GP_HPVS_Declaration of Conformity_EN
pdf, [315.31 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]
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_HPVS_Leaflet_EN
pdf, [148.05 kB]
Files are available only for registered users.