Diagnostic Value of the Care™ HPV Test in Screening for Cervical Intraepithelial Neoplasia Grade 2 or Worse

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Abstract

Background:

Cervical cancer is the fourth leading cause of cancer death in women worldwide. Persistent infection with a high risk human papillomavirus (HR-HPV) is the main etiological factor, so that early early detection of HR-HPV is very important. The aim of this study was to investigate the efficacy of Care™ HPV, a new method, as compared with Pap smear, PCR, and biopsy for screening purposes.

Material and Method:

In this cross-sectional study, 200 sexually active women aging from 25-50 years referred to the oncology clinic of Shahid Sodoughi Yazd Hospital in 2015 with a variety of cervix epithelial lesions or a need for colposcopy were enrolled. Results for Care™ HPV test (cervical), Pap smear, PCR, and biopsy were analyzed using SPSS 15 software and chi-square test, McNemar, and ROC curve analysis. Qualitative variables were compared using a Chi-square test.

Results:

Care™ HPV test sensitivity in detecting cervical intraepithelial neoplasia grade II (CIN-II) and also positive and negative predictive values were higher as compared to with other tests (p<0.05). The Pap smear test specificity was highest. There was no significant differences between Care™ HPV and PCR tests regarding detection of HPV-DNA in cases of CIN-II and worse (p>0.05).

Conclusion:

The Care™ HPV test has high sensitivity and predictive values for detecting HPV infection, with higher efficacy than the Pap smear test for tracking CIN-II. Therefore it may be recommended for use as a screening test in low-income areas.

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Most cited references 22

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Overview of the European and North American studies on HPV testing in primary cervical cancer screening.

Jack Cuzick, Christine Clavel, Karl-Ulrich Petry … (2006)

Several studies suggest that HPV testing is more sensitive than cytology in primary cervical screening. These studies had different designs and were reported in different ways. Individual patient data were collected for all European and North American studies in which cytology was routinely performed and HPV testing was included as an additional parallel test. More than 60,000 women were included. The sensitivity and specificity of HPV testing were compared with routine cytology, both overall and for ages <35, 35-49 and 50+. The age-specific prevalence of high risk HPV (hr-HPV) was also analysed. HPV testing was substantially more sensitive in detecting CIN2+ than cytology (96.1% vs. 53.0%) but less specific (90.7% vs. 96.3%). The sensitivity of HPV testing was similar in all studies carried out in different areas of Europe and North America, whereas the sensitivity of cytology was highly variable. HPV sensitivity was uniformly high at all ages, whereas the sensitivity of cytology was substantially better in women over the age of 50 than in younger women (79.3% vs. 59.6%). The specificity of both tests increased with age. Positivity rates for HPV testing in women without high-grade CIN were region dependent. These results support the use of HPV testing as the sole primary screening test, with cytology reserved for women who test HPV positive. Large demonstration projects are needed to fully evaluate this strategy. Copyright 2006 Wiley-Liss, Inc.

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Self-collection of vaginal specimens for human papillomavirus testing in cervical cancer prevention (MARCH): a community-based randomised controlled trial.

Eduardo Lazcano-Ponce, Attila Lorincz, Aurelio Cruz-Valdez … (2011)

Vaginal self-sampling for human papillomavirus (HPV) DNA testing could increase rates of screening participation. In clinic-based settings, vaginal HPV testing is at least as sensitive as cytology for detecting cervical intraepithelial neoplasia (CIN) grade 2 or worse; however, effectiveness in home settings is unknown. We aimed to establish the relative sensitivity and positive predictive value for HPV screening of vaginal samples self-collected at home as compared with clinic-based cervical cytology. We did a community-based, randomised equivalence trial in Mexican women of low socioeconomic status aged 25-65 years. Participants came from 540 medically underserved, predominantly rural communities in Morelos, Guerrero, and the state of Mexico. Our primary endpoint was CIN 2 or worse, detected by colposcopy. We used a computer-generated randomisation sequence to randomly allocate patients to HPV screening or cervical cytology. Eight community nurses who were masked to patient allocation received daily lists of the women's names and addresses, and did the assigned home visits. We referred women with positive results in either test to colposcopy. We did per-protocol and intention-to-screen analyses. This trial was registered with the Instituto Nacional de Salud Pública, Mexico, INSP number 590. 12,330 women were randomly allocated to HPV screening and 12,731 to cervical cytology; 9202 women in the HPV screening group adhered to the protocol, as did 11,054 in the cervical cytology group. HPV prevalence was 9·8% (95% CI 9·1-10·4) and abnormal cytology rate was 0·38% (0·23-0·45). HPV testing identified 117·4 women with CIN 2 or worse per 10,000 (95·2-139·5) compared with 34·4 women with CIN 2 or worse per 10,000 (23·4-45·3) identified by cytology; the relative sensitivity of HPV testing was 3·4 times greater (2·4-4·9). Similarly, HPV testing detected 4·2 times (1·9-9·2) more invasive cancers than did cytology (30·4 per 10,000 [19·1-41·7] vs 7·2 per 10,000 [2·2-12·3]). The positive predictive value of HPV testing for CIN 2 or worse was 12·2% (9·9-14·5) compared with 90·5% (61·7-100) for cytology. Despite the much lower positive predictive value for HPV testing of self-collected vaginal specimens compared with cytology, such testing might be preferred for detecting CIN 2 or worse in low-resource settings where restricted infrastructure reduces the effectiveness of cytology screening programmes. Because women at these sites will be screened only a few times in their lives, the high sensitivity of a HPV screen is of paramount importance. Instituto Nacional de Salud Pública, the Health Ministry of Mexico, QiAGEN Corp. Copyright © 2011 Elsevier Ltd. All rights reserved.

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Prevalence, incidence, and type-specific persistence of human papillomavirus in human immunodeficiency virus (HIV)-positive and HIV-negative women.

S. Cu-Uvin, M Safaeian, L Ahdieh … (2001)

Human immunodeficiency virus (HIV) infection and related immunosuppression are associated with excess risk for cervical neoplasia and human papillomavirus (HPV) persistence. Type-specific HPV infection was assessed at 6-month intervals for HIV-positive and HIV-negative women (median follow-up, 2.5 and 2.9 years, respectively). The type-specific incidence of HPV infection was determined, and risk factors for HPV persistence were investigated by statistical methods that accounted for repeated measurements. HIV-positive women were 1.8, 2.1, and 2.7 times more likely to have high-, intermediate-, and low-risk HPV infections, respectively, compared with HIV-negative women. In multivariate analysis, high viral signal, but not viral risk category, was independently associated with persistence among HIV-positive subjects (odds ratio [OR], 2.5; 95% confidence interval [CI], 2.1-2.9). Furthermore, persistence was 1.9 (95% CI, 1.5-2.3) times greater if the subject had a CD4 cell count 500 cells/microL). Thus, HIV infection and immunosuppression play an important role in modulating the natural history of HPV infection.

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Author and article information

Journal

Journal ID (nlm-ta): Asian Pac J Cancer Prev

Journal ID (iso-abbrev): Asian Pac. J. Cancer Prev

Title: Asian Pacific Journal of Cancer Prevention : APJCP

Publisher: West Asia Organization for Cancer Prevention (Iran )

ISSN (Print): 1513-7368

ISSN (Electronic): 2476-762X

Publication date (Print): 2017

Volume: 18

Issue: 3

Pages: 687-693

Affiliations

[1 ] Department of Obstetrics and Gynecology, Faculty of Medicine, Shahid Sadooghi University of Medical Science, Yazd, Iran

[2 ] Student Research Committee, Kurdistan University of Medical Sciences, Sanandaj, Iran

Author notes

[* ] For Correspondence: wesamkooti@ 123456yahoo.com

Article

Publisher ID: APJCP-18-687

DOI: 10.22034/APJCP.2017.18.3.687

PMC ID: 5464485

PubMed ID: 28440976

SO-VID: 85d570c3-89fe-48e7-81d4-26828249c362

License:

This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License

Diagnostic Value of the Care™ HPV Test in Screening for Cervical Intraepithelial Neoplasia Grade 2 or Worse

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Abstract

Background:

Material and Method:

Results:

Conclusion:

Related collections

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Most cited references 22

Overview of the European and North American studies on HPV testing in primary cervical cancer screening.

Self-collection of vaginal specimens for human papillomavirus testing in cervical cancer prevention (MARCH): a community-based randomised controlled trial.

Prevalence, incidence, and type-specific persistence of human papillomavirus in human immunodeficiency virus (HIV)-positive and HIV-negative women.

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