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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

EQA Panels

EQA results

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

Technical specification

Indication in vitro diagnostic medical device
Regulatory Status CE IVD
Intended User For professional use in laboratories with trained staff
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)

Sample Processing Channel Sensitivity Performed on
Without extraction (plasmid) FAM 745 IU/ml NIBSC 06/202, HPV 16
Without extraction (plasmid) Cy5 766 IU/ml NIBSC 06/202, HPV 16
croBEE®max Nucleic Acid Extraction Kit FAM 4758 IU/ml NIBSC 06/202, HPV 16
croBEE®max Nucleic Acid Extraction Kit Cy5 1558 IU/ml NIBSC 06/202, HPV 16
Without extraction (plasmid) FAM 1561 IU/ml NIBSC 06/206, HPV 18
Without extraction (plasmid) TexRed 2177 IU/ml NIBSC 06/206, HPV 18
croBEE®max Nucleic Acid Extraction Kit FAM 4906 IU/ml NIBSC 06/206, HPV 18
croBEE®max Nucleic Acid Extraction Kit TexRed 3262 IU/ml NIBSC 06/206, HPV 18
Diagnostic Specificity 99 % (CI95%: 93.6 % – 99.9 %)
Diagnostic Sensitivity 100% (CI95%: 87.7 % – 100 %)
Extraction/Inhibition Control

Proper sampling, DNA extraction efficiency and PCR inhibition control by endogenous Internal control (GAPDH gene)

Validated Specimen Cervical, vaginal and penile swab (transport medium: LBC medium NOVAPREP (Novacyte); SurePath (BD) Self-sampling device FLOQSwab (COPAN); Evalyn® Brush (Rovers medical))
Storage -20 ± 5 °C
Validated Extraction Methods

croBEE 201A Nucleic Acid Extraction Kit
GeneProof PathogenFree DNA Isolation Kit
croBEE®max Nucleic Acid Extraction Kit

Instruments croBEE Real-Time PCR System
AMPLilab Real-Time PCR System(detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
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
Gentier 96E/96R Real-Time PCR System (detection of high-risk HPV with differentiation of HPV 16 and HPV 18)
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)
Detection Channels FAM (HPV HR), HEX/JOE/VIC (IC), Cy5 (HPV 16), Texas Red/ROX (HPV 18), Cy5.5/Quasar 705 (HPV 45)
External Quality Assessment Regularly tested in QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com

Documentation

Instruction for Use

; Declaration of Verification of the kits with medical devices
pdf, [1.61 MB]
; GP_HPVS_Advisory_Notice_05_22_EN
pdf, [804.14 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, [544.98 kB]

MSDS

; GP_HPVS_Safety_Data_Sheet_EN
pdf, [274.3 kB]

Product Leaflet

; GP_HPVS_Leaflet_EN
pdf, [155.5 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]
; 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]
Files are available only for registered users.