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GeneProof Human Papilloma Virus (HPV) Screening PCR Kit

CE IVD

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
  • Housekeeping GAPDH for correct sampling control

CONTAMINATION PREVENTION

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

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/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 with 95% probability)

0.745 IU/µl (on 1st WHO International standard for Human Papillomavirus Type 16 DNA)
1.561 IU/µl (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 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
Instruments croBEE Real-Time PCR System
Applied Biosystems 7500 Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
AriaMx Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
CFX Connect™ Real-Time PCR Detection System (detection of high-risk HPV without differentiation)
CFX96™/Dx Real-Time PCR Detection System
LightCycler® 480 (detection of high-risk HPV without differentiation)
LineGene 9600 Plus
QuantStudio™ 3 Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 18)
QuantStudio™ 5 Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
Rotor-Gene Q (detection of high-risk HPV and presence HPV18, 16, and 45 but it does not distinguish coinfection of types 16, 18 and 45 respect
to the crosstalk between the channels TexRed/Cy5 and Cy5/Cy5.5)
SLAN® Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16)
Stratagene Mx3005p qPCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
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
Regulatory Status CE IVD 

Documentation

Instruction for Use

Declaration of Verification of the kits with medical devices
pdf, [1.49 MB]
GP_HPVS_Instruction for Use_EN
pdf, [65.68 kB]
GP_HPVS_Instruction_for_Use_FR
pdf, [241.91 kB]

Declaration of Conformity

GP_HPVS_Declaration of Conformity_EN
pdf, [315.31 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]
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]

Product Leaflet

GP_Leaflet_A4_HPVscreening-EN_2021
pdf, [219.15 kB]
Files are available only for registered users.