GeneProof Human Papilloma Virus (HPV) Screening PCR Kit
Kat.: HPVS/GP/025
A termék CE/IVD minősítéssel rendelkezik és az OGYÉI által nyilvántartásba vett.
24 magas kockázatú HPV típus detektálására és a 16, 18 és 45-ös típusok elkülönítésére alkalmas, ‘Ready-to-Use ‘ master mix. Az E1/E2 gént detektálja. (25 reakció)
Leírás
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
Technical specification
| Indication | in vitro diagnostic medical device |
| 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) |
0.745 IU/µl (on 1st WHO International standard for Human Papillomavirus Type 16 DNA) 1.561 IU/µl (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 201A Nucleic Acid Extraction Kit 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 |
| External Quality Assessment | Regularly tested by QCMD and INSTAND e.V. External Quality Assessment panels – results at www.geneproof.com |
| Regulatory Status | CE IVD |
