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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, [155.5 kB]
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EQA results

EQA results

; GP_HPVS_Instand_07_22_EN
pdf, [1.06 MB]
; GP_HPVS_Instand_06_21_EN
pdf, [1 MB]
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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_05_22_EN
pdf, [804.14 kB]
; GP_HPVS_Instructions_for_Use_IT
pdf, [664.32 kB]
; GP_HPVS_Instruction_for_Use_EN
pdf, [298.39 kB]
; GP_HPVS_Instruction_for_Use_ES
pdf, [141.96 kB]
; GP_HPVS_Instruction_for_Use_FR
pdf, [145.27 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]