Nearly all cervical cancers are caused by HPV (Human papillomavirus)4
Primary HPV testing is highly sensitive, catching disease 98% of the time in the general population.5 A Pap alone does not test for HPV.
3 Cervical Cancer Screening Tests
There are three tests approved for cervical cancer screening. These tests are good at finding cancer and pre-cancer, but the Primary HPV test is better at preventing cervical cancers and is the more efficient test.6
Primary HPV
Test Sensitivity: Primary HPV testing is highly sensitive, catching disease 98% of the time in the general population, rarely missing cases where HPV-related disease is present.5 In addition, a negative result means a very low risk of HPV-related precancer or cancer developing in the screening interval.
Screening Guidelines: The recommended screening test by the ACS and USPSTF.
Co-test (HPV test + Pap)
Test Sensitivity: Highly sensitive because it is performing a Primary HPV test and the Pap test, but it is highly inefficient to perform two tests on all women and it can lead to more unnecessary follow-up tests (12% more colposcopies than HPV test).10
Screening Guidelines: Listed as an alternative to Primary HPV testing because it is less efficient. The dual tests could be reserved for the subset of women who have abnormal results.
Pap smear
Test Sensitivity: Least sensitive test, compared to HPV testing (53% sensitivity, when compared to HPV test).11 Pap smears identify changes in cervical cells after possibly cancerous transformation has taken place. A Pap alone does not test for HPV.
Screening Guidelines: Listed as an alternative to Primary HPV testing and must be performed more often (more frequent screening interval) due to lower sensitivity.
“If we were to start cervical cancer screening today, we’d never select a screening test with a sensitivity of 50% if there was an alternative with greater than 90%.
It’s time we allow the Pap test to enjoy a well-deserved retirement.7”
Thomas Lorey, MD, pathologist, senior consultant and former director of laboratory services for Kaiser Permanente Northern California
Cervical Cancer Screening: Then and Now
First introduced in the 1940s and called the Pap smear, cervical cancer screening tests have evolved in the last couple of decades, however, the collection method has remained the same, until now.
1940s & 1996
Pap smears started in the 1940’s (50-75% sensitivity12) with liquid based cytology entering in 1996 (+10% sensitivity). Samples were collected with a speculum and brush and evaluated for cell changes.
2003 & 2014
HPV tests started in 2003 (72-90% sensitivity13, 14) and were used as an adjunct to a Pap and then as a co-test. The first Primary HPV test was FDA-approved in 2014 (95%+ sensitivity15). Samples still collected with a speculum and brush.
Now
Primary HPV tests, the recommended test, unlock the ability for women to self-collect their sample without a speculum (>98% relative sensitivity16). Self-collection in a healthcare setting is FDA-approved in 2024 with at-home collection under review.
Primary HPV enables at-home self-collection
Primary HPV testing is the most sensitive test for cervical cancer screening and it allows for self-collection, which is crucial for overcoming barriers to screening such as discomfort and access, and increasing screening engagement.
The Teal WandTM, when FDA approved, will allow a woman to collect a sample for Primary HPV testing, from the comfort and convenience of home.
See How It Will Work
Self-collect Primary HPV testing around the world
Primary HPV tests are the preferred screening method in many countries, especially well resourced settings.8 In addition, many countries already have self-collection cervical cancer screening programs using Primary HPV testing.
The World Health Organization (WHO), along with all 194 members, have vowed to accelerate the elimination of cervical cancer9 as a public health problem. Some countries are on track to do so within the coming decade, through their ability to reach more women with at-home self-collection.
Eliminate Cervical Cancer in the U.S.
Dive Deeper Into the Research
U.S. Clinical Study Demonstrates 94% of Women Prefer At-Home Cervical Cancer Screening
Read moreHow Stigma Can Stifle Care: Rethinking HPV Risk and Progression of Infection to Cervical Cancer
Read moreHow At-Home Self-Collection Can Improve Cervical Cancer Screening Engagement Among the LGBTQ+ Community
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Sources
1https://www.cancer.org/cancer/types/cervical-cancer/detection-diagnosis-staging/screening-tests/hpv-test.html
2https://www.cancer.org/cancer/types/cervical-cancer/detection-diagnosis-staging/cervical-cancer-screening-guidelines.html
3https://www.uspreventiveservicestaskforce.org/uspstf/draft-recommendation/cervical-cancer-screening-adults-adolescents
4ncer.gov/about-cancer/causes-prevention/risk/infectious-agents/hpv-and-cancer
5https://pmc.ncbi.nlm.nih.gov/articles/PMC8316144/
6https://www.cancer.org/cancer/risk-prevention/hpv/hpv-and-hpv-testing.html
7https://www.captodayonline.com/hpv-test-self-collection-set-in-motion/
8https://pmc.ncbi.nlm.nih.gov/articles/PMC9514784/
9https://www.who.int/news/item/17-11-2023-global-partners-cheer-progress-towards-eliminating-cervical-cancer-and-underline-challenges
10https://aacrjournals.org/cebp/article/30/3/432/72450/Cervical-Cancer-Screening-Past-Present-and
11https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(11)70188-7/abstract
12https://pubmed.ncbi.nlm.nih.gov/18165406/ 13https://pubmed.ncbi.nlm.nih.gov/9466651/
14https://pubmed.ncbi.nlm.nih.gov/18973271/
15https://www.accessdata.fda.gov/cdrh_docs/pdf19/P190028S009C.pdf
16https://www.bmj.com/content/363/bmj.k4823