Several methods have been used to diagnose clinical or subclinical infection with HPVs including clinical observation, cytological screening by Pap smear, electron microscopy, immunocytochemistry, but these methods have some disadvantages such as non-standardization and subjectivity, insufficient sensitivity and low predictable value. The most perspective way of HPV diagnosis is a direct detection of DNA of the human papilloma virus of high carcinogenic risk by the PCR.

While the value of the Pap smear in routine screening for cervical dysplasia is undisputed, it is now known that 99% of cases of cervical carcinoma are caused by infection with twelve genotypes of the human papillomavirus (HPV). Identification of these high-risk genotypes is very valuable in the management of cervical carcinoma, both as a prognostic indicator and as a secondary screening test where results of a Pap smear are inconclusive. Results from the combination of the Pap smear and the HPV DNA test can aid in determining the intervals for screening.

Carigen uses PCR-based methods that have been used successfully for the detection and typing of genital HPV genotypes in clinical specimens such as cervical swabs or scrapes, cervicovaginal lavages, frozen biopsies and formalin-fixed paraffin-embedded tissues.

Our HPV High-Risk Screen is an in vitro Real-Time amplification test for the qualitative detection of Human Papillomavirus (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59) in the urogenital swabs, tissue and Liquid-based cytology samples.

The DNA Screen report will indicate the specific group to which the test sample HPV belongs.The screen also indicates the amount of HPV present to determine the significance of the infection.

The test sample is an endocervical brush or a penile swab for males.

The turnaround time for this test is 3 – 5 business days. Turnaround times begins when samples get to our facility.

Click for more information on Human Papilloma Virus (HPV).