Human

Testing guidelines:
1. Detection and disease monitoring of high-risk genotypes associated with the

development of cervical cancer.
2. As part of regular co-testing for cervical cancer screening, alongside cytologic
testing. The co-testing involving both HPV DNA and cytologic testings is especially
recommended to be performed for women aged between 30-65 years old every 5
years.1
3. More information about the cervical-cancer screening guidelines is provided in the
Clinical Background Section below.
Clinical Background
Human papillomavirus (HPV) is a non-enveloped and double-stranded DNA virus carrying a
genome of approximately 7900 nucleotides in length. It infects oral, genital, and skin
membranes of humans. HPV is mainly transmitted through sexual contact, besides other
possible non-sexual contacts, such as skin-to-skin, skin-to-mucosa, and mucosa-to-mucosa
contacts.2 More than 150 HPV genotypes have been identified on the basis of DNA sequence
data showing genome differences. Some HPV genotypes are carcinogenic, which cause more
than 50% of infection-linked cancers in women and approximately 5% in men. 3 Of note,
genital HPV infections contribute to more than 99% of cervical cancer cases, 97% of anal
cancer, 70% of vaginal cancer cases, 47% of penile cancer cases, 40% of vulvar cancer cases,
47% of oropharyngeal cancer cases, and 11% of oral cavity cancer cases. 2 Other genotypes
can cause warts (verrucae) while others have no clinical symptoms in infected persons.
Diseases associated with the HPV infection are listed in the Table 1 (modified from Grce et
al., 2014).
Table 1 Disease associated with common human papillomaviruses (HPV) (Adapted and
modified from Grce et al. 2014). High-risk genotypes are emphasized in bold fonts.
HPV can be grouped into low-risk and high-risk (carcinogenic) types. Low-risk types
include 6 and 11.2 High-risk types include 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59. 4,5
Among the different disease manifestations caused by the HPV virus, the cervical cancer, of
which >99% of the cases are associated with the HPV infection, causes the most disease
burden to the population. Notably, there are approximately 530,000 new cervical cancer
cases detected in worldwide annually, with mortality rate of 275,000 deaths per year.6 In
Asia, the HPV-16 is the most carcinogenic genotype, accounting for almost 60% of cervical
cancer cases.7,8 The second most carcinogenic genotype, HPV-18 is accounting for 11-15% of
all cervical cancers.7,8
Genital HPV infection is very common in women, especially among young women.
However, 60% of the HPV infections in women are generally cleared by effective autoimmune response within 1 year and 91% are cleared within 2 years. 9 In contrast, 50% of the
HPV infections in men are generally cleared by auto-immune response within 6 months and
90% within 18 months.10 Nonetheless, only a small percentage of the permanent infections
with high-risk HPV develop cervical cancer and its precursor lesions. A Cervical-cancer
screening guideline summarized from 3 major sets of screening guidelines issued by the
American Cancer Society, American Society of Colposcopy and Cervical Pathology, and
American Society of Clinical Pathology Multisociety Guidelines Group; the American
College of Obstetricians and Gynecologists; and the U.S. Preventive Services Task Force, is
provided in Table 2 (Adapted and modified from Schiffman et al., 2013).
Table 2 Cervical-cancer screening guideline (Adapted and modified from Schiffman et al.,
2013).
Age Group
Screening Recommendation
<21 yr
Do not screen since the adolescent are at extremely
low risk for cervical cancer but high rates of
impermanent HPV infections.
21-29 yr
The prevalence of HPV remains very high, but the
risk of cancer increases only slightly, therefore
perform cytologic testing alone every 3 years.
However, if the cytologic result is atypical squamous
cells of undetermined significance, then reflex HPV
testing is used as a triage test; among women 25
years of age or older, reflex HPV testing is preferred
over repeat cytologic testing or immediate
colposcopy.
30-65 yr
Perform cytologic and HPV cotesting every 5
years (preferred), or perform cytologic testing alone
every 3 years (acceptable)
>65 yr
Discontinue screening if there has been an adequate
number of negative screening results previously (3
consecutive negative cytologic tests or 2 consecutive
negative cotests in the past 10 years, with the most
recent test in the past 5 years) and if there is no
history of high-grade squamous intraepithelial
lesions, adenocarcinoma in situ, or cancer.
Women who
have
Discontinue screening if the patient has undergone a
undergone
total hysterectomy with removal of cervix and if
hysterectom there is no history of HSIL, adenocarcinoma in situ, or
y
cancer.
Nucleic acid-based HPV testing HK: yellow highlighted to change, just a rough
context idea to present, will insert after I understand more about all our hpv-related inhouse
test Nucleic acid (DNA) testing by PCR has become a standard, noninvasive method for
determining the presence of a cervical HPV infection. Proper implementation of nucleic acid
testing for HPV may 1) increase the sensitivity of cervical cancer screening programs by
detecting high-risk lesions earlier in women 30 years and older with normal cytology and 2)
reduce the need for unnecessary colposcopy and treatment in patients 21 and older with
cytology results showing atypical squamous cells of undetermined significance (ASC-US).
References:
1.
Schiffman M, Solomon D. Clinical practice. Cervical-cancer screening with human
papillomavirus and cytologic cotesting. The New England journal of medicine
2013;369:2324-31.
2.
Grce M, Mravak-Stipetic M. Human papillomavirus-associated diseases. Clinics in
dermatology 2014;32:253-8.
3.
zur Hausen H. Papillomaviruses in the causation of human cancers - a brief historical
account. Virology 2009;384:260-5.
4.
Katki HA, Schiffman M, Castle PE, et al. Five-year risks of CIN 3+ and cervical
cancer among women with HPV-positive and HPV-negative high-grade Pap results. Journal
of lower genital tract disease 2013;17:S50-5.
5.
Katki HA, Schiffman M, Castle PE, et al. Benchmarking CIN 3+ risk as the basis for
incorporating HPV and Pap cotesting into cervical screening and management guidelines.
Journal of lower genital tract disease 2013;17:S28-35.
6.
Ferlay J, Shin H, Bray F, Forman D, C. M, Parkin D. Cancer incidence and mortality
worldwide. GLOBOCAN 2008. Lyon, France: International Agency for Research on Cancer;
2008.
7.
de Sanjose S, Quint WG, Alemany L, et al. Human papillomavirus genotype
attribution in invasive cervical cancer: a retrospective cross-sectional worldwide study. The
Lancet Oncology 2010;11:1048-56.
8.
Guan P, Howell-Jones R, Li N, et al. Human papillomavirus types in 115,789 HPVpositive women: a meta-analysis from cervical infection to cancer. International journal of
cancer Journal international du cancer 2012;131:2349-59.
9.
Dunne EF, Unger ER, Sternberg M, et al. Prevalence of HPV infection among
females in the United States. Jama 2007;297:813-9.
10.
Giuliano AR, Lu B, Nielson CM, et al. Age-specific prevalence, incidence, and
duration of human papillomavirus infections in a cohort of 290 US men. The Journal of
infectious diseases 2008;198:827-35.

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Testing guidelines:

1. Detection and disease monitoring of high-risk genotypes associated with the

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