CLART HPV 4 – CLART HPV 4-Amplification

• DESCRIPTION OF THE DETECTION SYSTEM

CLART® HPV4 is available in two analysis formats:

• CLART® HPV4, which enables to detect the 35 most clinically relevant types of Human Papillomavirus (6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43, 44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68 and 70, 71, 72, 73, 81, 82, 83, 84, 85 and 89); and
• CLART® HPV4c, which enables to detect the following 16 HPV types: 14 high oncogenic risk types (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68) and 2 low oncogenic risk types (6y 11).

Starting material for both formats may be both swabs as well as cell suspensions.

Detection is based on our CLART® technology: PCR amplification of a fragment of the viral region L1, followed by visualization in low-density microarray. The chosen sequence is highly conserved in all HPV types, while at the same time displays enough variations among HPV types so as to distinguish each type by means of specific probes.

Basically, PCR amplified products labelled with biotin, hybridize with their specific complementary probes immobilised in well-defined areas of the microarray. Subsequent incubation steps take place thereon: first, with a streptavidin-peroxidase conjugate, and second, with an o-dianisidine substrate.

A non-soluble product precipitates thereafter in regions of the microarray where specific hybridization between amplified products and their specific probes has taken place.

Thereafter, analysis and interpretation of results are automatically performed by GENOMICA’s reader (CAR® or CLINICAL ARRAY READER), running tailor-made software. Autoclart® plus may alternatively be used.