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 Human Papillomavirus (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 REF Technology Packaging
GeneProof Human Papillomavirus (HPV) Screening PCR Kit HPVS/GP/025 real-time PCR 25 reactions
GeneProof Human Papillomavirus (HPV) Screening PCR Kit HPVS/GP/100 real-time PCR 100 reactions

Product Leaflet

Product Leaflet

; GP_STI_Panel_Leaflet_EN
pdf, [4.16 MB]
; GP_HPVS_Leaflet_EN
pdf, [139.68 kB]
Choose all

EQA results

EQA results

; GP_HPVS_Instand_07_22_EN
pdf, [1.06 MB]
; GP_HPVS_Instand_06_21_EN
pdf, [1 MB]
Choose all

Files are available only for registered users.

Declaration of Verification

; Declaration of Verification of the kits with medical devices
pdf, [2.53 MB]

Instructions for Use & Advisory Notice

; GP_HPVS_Advisory_Notice_02_24_CS_EN
pdf, [680.35 kB]
; GP_HPVS_Advisory_Notice_03_24_CS_EN
pdf, [473.42 kB]
; GP_HPVS_Advisory_Notice_05_22_EN
pdf, [804.14 kB]
; GP_HPVS_Instructions_for_Use_EN
pdf, [661.67 kB]

Declaration of Conformity

; GP_HPVS_Declaration_of_Conformity_EN
pdf, [586.8 kB]

MSDS

; GP_HPVS_Safety_Data_Sheet_EN
pdf, [274.3 kB]