Human Papillomavirus (HPV)


Cervical cancer is the second most common cancer in women after breast cancer.

14 high risk HPV genotypes contribute to the majority of cervical cancer cases. The main reasons for the higher incidence and mortality in developing countries are lack of awareness of cervical cancer among the population, lack of screening programs, and limited access to health care services.

According to data from WHO, the number of women at risk for cervical cancer is over 2 billion, primarily in developing worlds. The number of cervical cancer rates and deaths is projected to almost double by 2025.


Human Papillomavirus (HPV) is a small, non-enveloped, double-stranded DNA virus (approximately 8,000 base pairs) that replicates in the nucleus of squamous epithelial cells and induces hyperproliferative lesions. HPV infections are among the most common sexually transmitted infections.
Most HPV infections have a benign clinical consequence and are cleared spontaneously. However, persistent HPV infection may result in progression to cervical cancer. More than one hundred different HPV genotypes have been identified, among which over forty infect mucosal and genital epithelia. Genital HPV genotypes are generally classified into high risk (HR) and low risk (LR) groups based on their carcinogenic potential.

HR HPV genotypes are associated with invasive cervical cancer or its immediate precursor (high-grade squamous intraepithelial lesion, cervical intraepithelial neoplasia or carcinoma in situ), whereas LR HPV genotypes include benign lesion and are not associated with cervical cancer. Approximately 70% of invasive cervical cancer cases worldwide are caused by HPV 16 and HPV 18.

Infection by HPV 16 or HPV 18 is associated with higher risk of disease progression compared to other HR HPV genotypes. Compared with cervical screening methods identifying cytological abnormalities, molecular tests that specifically detect the presence of HR HPV DNA in cervical cells can potentially increase sensitivity and cost-effectiveness of cervical cancer screening programs. Furthermore, HPV DNA tests can be effectively used in triaging patients with equivocal cytology, in post-therapeutic follow-up and in monitoring vaccine efficacy.

The RealTime High Risk (HR) HPV DNA assay is a qualitative in vitro test that amplifies and detects HR HPV DNA in cervical cells collected in liquid media. The detection of fourteen HR HPV genotypes (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) is achieved through a primer mix targeting a conserved region of HPV genomes and single-stranded DNA probes. The assay can differentiate between HPV 16, HPV 18 and non-HPV 16/18 genotypes (Other HR HPV).

Specimen Collection and Handling

Specimens collected in Liquid Cytology Pap Test solution can be used. Cervical specimens collected in Liquid Cytology Pap Test solution (universal specimen medium) can be transported at 2 ‘C to 30 ‘C and may be stored for up to 14 days at 2 ‘C to 30 ‘C or up to 90 days at -10 ‘C or colder following collection.

Specific key messages to patients receiving cervical screening:


  • The purpose of regular, lifelong cervical cancer screening is to identify cervical cancer precursors, which can be treated before progression to cervical cancer.


  • A positive high-risk HPV DNA test or an abnormal cervical cytology test is not indicative of cervical cancer.Appropriate follow-up is necessary to ensure that cervical abnormalities do not progress.

  • Some women might have a normal Pap test and a positive high-risk HPV test. A positive high risk HPV DNA test indicates a HPV infection of the cervix, but does not indicate cervical cancer.A normal cervical cytology test indicates that no cellular abnormalities were detected at the time of testing, but women who have HPV infection of the cervix have a higher likelihood of developing cell changes, which could lead to cervical cancer over time. Follow-up evaluation is essential to monitor cervical cytology.


  • A Pap test that reveals ASC-US (atypical squamous cells of undetermined significance) indicates some abnormal areas on the cervix that may require close follow-up or treatment so that they do not progress. Additional testing might be required to confirm these results. It is essential that patients return for all follow-up appointments and recommended tests.


  • HPV is very common. It can infect the genital areas of both men and women. It usually has no signs or symptoms.


  • Most sexually active persons get HPV at some time in their lives, though most will never know it. Even persons with only one lifetime sex partner can get HPV if their partner was infected


  • While the immune system clears HPV infection most of the time, in some persons, HPV infection does not resolve.


  • No clinically validated test exists for men to determine if they have HPV infection. The most common manifestation of HPV infection in men is genital warts. High-risk HPV types seldom cause genital warts.


  • Partners who are in a long-term relationship tend to share HPV. Sexual partners of HPV-infected patients also likely have HPV, even though they might have no signs or symptoms of infection.


  • Detection of high-risk HPV infection in a woman does not mean that the woman or her partner is engaging in sexual activity outside of a relationship. HPV infection can be present for many years before it is detected, and no method can accurately confirm when HPV infection was acquired.





What is the cervix?

The cervix is the opening of the uterus (womb). It is part of a woman’s reproductive system.

What causes cervical cancer?

A virus, called Human Papillomavirus (HPV) can cause normal cells on your cervix to turn abnormal. Over many years, abnormal cells can turn into cancer if they are not found and treated by your doctor.

What is Human Papillomavirus (HPV)?


  • It is a very common virus.
  • There are more than 100 types.
  • Some types cause benign warts on the fingers or feet.
  • More than 30 types can be transmitted sexually.
  • About 15 sexually transmitted types, called high-risk types, can cause cervical cancer. Two of these, HPV types 16 and 18, are responsible for the majority of HPV-caused cancers.
  • Some other sexually transmitted types, called low-risk types, cause external warts on the genitals that are not cancerous.


How could I get HPV?

HPV is passed on through genital or skin-to-skin contact. It often does not cause symptoms until it is advanced. All women who ever had sex are at risk for cervical cancer. So, it is important to get screened even when you feel healthy.

How can I prevent cervical cancer?

You can prevent cervical cancer with regular screening tests, like the Pap test and the HPV DNA test. Screening tests can find early problems before they become cancer. That way, problems can be found and removed before they ever become cancer.

The Pap and HPV DNA tests look for different things:

The Pap Test: checks your cervix for abnormal cells that could turn into cervical cancer

The HPV DNA Test: checks your cervix for the virus (HPV) that can cause abnormal cells and cervical cancers.

* HPV DNA Test Information

The RealTime High Risk HPV DNA assay is a qualitative in vitro test for the detection of 14 High Risk HPV genotypes (16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) and identification of HPV genotypes 16 and 18 in cervical cells collected in liquid media.

What are the benefits of Pap & HPV DNA co-testing?

Study showing women who had both pap smear and HPV DNA negative result has the lowest risk of developing cervical cancer.

What is the best time to be screened for cervical cancer?

The best time for a woman to have cervical screening is between 10 and 20 days after the first day of her last menstrual period. For about 2 days before the test, she should avoid sexual intercourse, douching, or using vaginal medicines or spermicidal foams, creams, or jellies.

Do women who have been vaccinated against HPVs still need to be screened for cervical cancer?

Yes. Because current HPV vaccines do not protect against all HPV types that cause cervical cancer, it is important for vaccinated women to continue to undergo routine cervical cancer screening.
Please view / download pdf version of New Cervical Cancer Screening Strategy: Combined Pap Test and HPV DNA Test