GeneProof Human Papillomavirus (HPV) Screening PCR Kit

CE IVD

PRODUCT ADVANTAGES

The PCR kit is designed for the detection of 24 high-risk types of Human Papillomavirus (HPV) and typization of HPV 16, 18, 45 by the real-time Polymerase Chain Reaction (PCR) method.

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 widespreading of HPV screening through simple and comfortable sampling

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

CONTAMINATION ELIMINATION

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

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

The product will be ready for deliveries at the beginning of April 2020.

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)

reaches up to 0.745 IU/µl with the probability of 95 %
(on 1st WHO International standard for Human Papillomavirus Type 16 DNA)
reaches up to 1.561 IU/µl with the probability of 95 %
(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 NA16 Nucleic Acid Extraction System
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
Quality Control In accordance with ISO 13485, each lot of GeneProof PCR Kit is tested against predetermined specifications to ensure consistent product quality
External Quality Assessment regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com
Certification CE IVD for in vitro Diagnostics Use

 * Validated Instruments

ORDER INFORMATION

Product name

Cat. No. Technology Package
GeneProof Human Papillomavirus (HPV) Screening PCR Kit HPVS/GP/025 real-time PCR 25 reaction
GeneProof Human Papillomavirus (HPV) Screening PCR Kit HPVS/GP/050 real-time PCR 50 reaction
GeneProof Human Papillomavirus (HPV) Screening PCR Kit HPVS/GP/100 real-time PCR 100 reaction