HPV high risk En

Rely-AMP HPV High Risk

Human papillomavirus (HPV) is a DNA virus, that is capable of establishing productive infections only in keratinocytes of the skin or mucous membranes. HPV infections are believed to cause 96% of cervical cancer. More than 120 genotypes of HPV have been identified, of these, 14 genotypes have been classified as “high-risk HPV” (HR-HPV) because they can lead to cervical cancer.

High Risk HPV	Frequency Europe (%)
16	58,1
18	15,7
31	4,0
33	4,4
35	1,6
39	0,2
45	2,9
51	0,2
52	0,6
56	1,2
58	1,0
59	0,2
66	0,2
68	0,2

DETAILS

Rely-AMP HPV is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of 14 HPV High Risk from clinical specimens. Rely-AMP HPV provides all necessary reagents for reliable detection of all High Risk HPV.

The kit is designed for the detection of the High Risk HPV DNA, based on the amplification of the specific sequence of the L1 region of Papilloma virus, by Real time PCR multiplex. The system has an internal control, based on amplification of Human RNase. Furthermore Rely-AMP HPV allows the genotyping of the HPV 16 and HPV 18.

TECHNICAL SPECIFICATION

Quantitative/qualitative	Qualitative
Extraction	Magnetic Resin
Technology	Multiplex Real time PCR
Sample type	Cervical swabs in Medium PreservCyt
Thermal cycler	Optimized with CFX96 (Bio-Rad) but designed for use with real-time devices from various manufacturers
Internal control	RNasi gene
Positive control	HPV plasmid DNA
Amplified region	L1
Fluorophore	FAM - HEX - CY5
Processing	Manual Automated
Time to result	2 hours (after extraction)

PERFORMANCE

Diagnostic sensitivity: 90%

Diagnostic specificity: 98%

Analytical Specificity: no cross reaction

Analytical sensitivity:

High Risk HPV	Copies/ml
16	300
18	500
31	500
33	500
35	500
39	500
45	300
51	300
52	1500
56	600
58	600
59	600
66	1500
68	1500

ORDERING INFORMATION

PRODUCT

CAT.NO.

PRICE

Rely-AMP HPV

extraction and detection kit

HPV HR50

Rely-AMP HPV

detection kit

HPV HR50D