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GeneProof Human Papillomavirus (HPV) Screening PCR Kit

CE IVD

GeneProof Human Papillomavirus (HPV) Screening PCR Kit has expanded compatibility! 

The assay is now validated for use with BD SurePathTM Preservative Fluid and PreservCytTM Solution (Hologic), along with other transport media and self-sampling devices. 

PRODUCT ADVANTAGES

DIFFERENTIATION OF HIGH-RISK TYPES 16, 18 AND 45

  • The kit detects a pool of high-risk HPV types with differentiation of types 16, 18 and 45 
  • HPV16 and HPV18 are responsible for 70 % of cervical cancer cases and pre-cancerous cervical lesions, while HPV45 is the 3rd most prevalent genotype in cases of invasive cervical cancer worldwide (5–6%) (1), (2)

TRANSPORT MEDIA COMPATIBILITY

  • With the most commonly used transport media validated, the assay is easy to adopt into your laboratory's existing workflow 

  • Validated for use with:  

    • PreservCytTM Solution (Hologic) 

    • BD SurePathTM Preservative Fluid 

    • NOVAPrep® Solution (Novacyte) 

SELF-SAMPLING OPTION

  • Compatible with devices for simple and convenient self-sampling

  • Validated for use with: 

    • Evalyn® Brush (Rovers Medical) 

    • FLOQSwab® (COPAN) 

  • Proper sampling can be assessed through the endogenous internal control (GADPH gene)

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

 

(1) Wang R, Pan W, Jin L, Huang W, Li Y, Wu D, Gao C, Ma D, Liao S. Human papillomavirus vaccine against cervical cancer: Opportunity and challenge. In: Cancer Letters [Internet]. Amsterdam (NL): Elsevier; 2020 Feb 28;471:88-102. Available from: [https://doi.org/10.1016/j.canlet.2019.11.039].

(2) Andrews J. HPV45: Why does it matter? Clinical utility in risk-stratified cervical cancer screening & management: systematic review. In: ASSCP 2018 Annual Meeting [Internet]. Sparks (MD): BD Life Sciences; 2018. Available from: [https://www.asccp.org/Assets/3e568d4b-5fb4-4e82-9c5b-ee648207a56a/636603484014070000/1140-jeff-andrews-pdf]

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, [491.02 kB]
; GP_HPVS_Leaflet_EN
pdf, [139.68 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]
Choose all

Files are available only for registered users.

Declaration of Verification

; Declaration of Verification of the kits with medical devices
pdf, [2.17 MB]

Instructions for Use & Advisory Notice

Instructions for Use are for informative purposes only

; GP_HPVS_Advisory_Notice_02_24_CS_EN
pdf, [680.35 kB]
; GP_HPVS_Advisory_Notice_02_25_CS_EN
pdf, [1.69 MB]
; 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_Advisory_Notice_06_24_CS_EN
pdf, [1.07 MB]
; GP_HPVS_Instructions_for_Use_EN
pdf, [658.36 kB]
; GP_HPVS_Instructions_for_Use_ES
pdf, [675.98 kB]
; GP_HPVS_Instructions_for_Use_FR
pdf, [539 kB]
; GP_HPVS_Instructions_for_Use_IT
pdf, [670.02 kB]
; GP_HPVS_Instructions_for_Use_PL
pdf, [543.76 kB]
; GP_HPVS_Instructions_for_Use_PT
pdf, [751.49 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]