ENGLISH      FRANÇAIS



Home / Screening & vaccine topics / Cervical cancer / Screening Technologies to Advance Rapid Testing for Cervical Cancer Prevention (START project)

  Screening Technologies to Advance Rapid Testing for Cervical Cancer Prevention (START project)

The study entitled “START Project: Screening Technologies to Advance Rapid Testing for Cervical Cancer Prevention” is sponsored by the Program for Appropriate Technology in Health (PATH), Seattle. The overall goal of the START project is to advance cervical cancer prevention in low- and medium-resource countries by facilitating the development and validation of appropriate, affordable and effective biochemical test formats for detecting CIN and early cervical cancer by the detection of oncogenic HPV types.

The primary objective of the study is to develop simple, rapid, accurate, safe, acceptable, and inexpensive biochemical tests for the detection of oncogenic HPV infection which can be used in cervical cancer screening programs in low-resource settings and contribute to the reduction of cervical cancer burden in developing countries. The test formats currently available are cumbersome, expensive, labour intensive and, thus, are inappropriate for use in developing countries. The study aims to produce affordable, less expensive, accurate, user friendly and validated HPV tests by modifying or developing biochemical test technology to develop two test formats, namely the rapid batch test format and the rapid strip test format, for ready use in low-resource settings.
The secondary objectives of the study are to:
  • Evaluate the concurrent performance of other screening tests such as cervical cytology, visual inspection with acetic acid (VIA) and with Lugol’s iodine (VILI) in detecting cervical neoplasia.
  • Test the relative strengths of various risk factors for HPV infection and cervical neoplasia.
PATH collaborated with the Cancer Institute of Chinese Academy of Medical Sciences (CICAMS), Beijing, China and the International Agency for Research on Cancer (IARC), Lyon, France to organize the field component of the START project. The IARC established collaborative research agreements with the Tata Memorial Centre (TMC), Mumbai and the Nargis Dutt Memorial Cancer Hospital (NDMCH), Barshi , India, to carry out the Indian component of the START project. The TMC and NDMCH organized the Indian field study in Mohol and North Solapur tehsils (subdistricts) Solapur district.
The Indian component of the START project aimed to collect vaginal and cervical cell samples from women with histologically confirmed CIN, as well as from a proportion of healthy women to research, develop, verify, and validate these new tests in the field studies. Thus, the project involved obtaining vaginal and cervical specimens, screening women and treating those with high-grade cervical cancer precursor lesions and invasive cervical cancer, transfer of a selection of biological samples to PATH, and validation and evaluation of prototype tests.





Article in The Lancet Oncology 2008; 9:929-936
A new HPV-DNA test for cervical-cancer screening in developing regions: a cross-sectional study of clinical accuracy in rural China
Qiao YL, Sellors JW, Eder PS, Bao YP, Lim JM, Zhao FH, Weigl B, Zhang WH, Peck RB, Li L, Chen F, Pan QJ, Lorincz AT.
Background: A new test (careHPV; QIAGEN, Gaithersburg, MD, USA) has been developed to detect 14 high-risk types of carcinogenic human papillomavirus (HPV) in about 2·5 h, to screen women in developing regions for cervical intraepithelial neoplasia (CIN). We did a cross-sectional study to assess the clinical accuracy of careHPV as a rapid screening test in two county hospitals in rural China.
Methods: From May 10 to June 15, 2007, the careHPV test was done locally by use of self-obtained vaginal and provider-obtained cervical specimens from a screening population-based set of 2530 women aged 30 to 54 years in Shanxi province, China. All women were assessed by visual inspection with acetic acid (VIA), Digene High-Risk HPV HC2 DNA Test (HC2), liquid-based cytology, and colposcopy with directed biopsy and endocervical curettage as necessary. In 2388 women with complete data, 441 women with negative colposcopy, but unsatisfactory or abnormal cytology or who were positive on HC2 or the new careHPV test, were recalled for a second colposcopy, four-quadrant cervical biopsies, and endocervical curettage. An absence of independence between the tests was not adjusted for and the Bonferroni correction was used for multiple comparisons.
Findings: Complete data were available for 2388 (94·4%) women. 70 women had CIN2+ (moderate or severe CIN or cancer), of whom 23 had CIN3+. By use of CIN2+ as the reference standard and area-under-the-curve analysis with a two-sided alpha error level of 0·0083, the sensitivities and specificities of the careHPV test for a cut-off ratio cut-point of 0·5 relative light units, were 90·0% (95% CI 83·0–97·0) and 84·2% (82·7–85·7), respectively, on cervical specimens, and 81·4% (72·3–90·5) and 82·4% (80·8–83·9), respectively, on vaginal specimens (areas under the curve not significantly different, p=0·0596), compared with 41·4% (29·9–53·0) and 94·5% (93·6–95·4) for VIA (areas under the curve significantly different, p=0·0001 and p=0·0031, for cervical and vaginal-specimen comparisons for the careHPV test, respectively). The sensitivity and specificity of HC2 for cervical specimens were 97·1% (93·2–100) and 85·6% (84·2–87·1), respectively (areas under the curve not significantly different from the careHPV test on cervical specimens, p=0·0163).
Interpretation: The careHPV test is promising as a primary screening method for cervical-cancer prevention in low-resource regions.
Funding Bill & Melinda Gates Foundation.


Audio presentations - HPV:
Chapter 9: Strategic planning
9b. Required infrastructure for the successful implementation of an HPV vaccination programme

H. Sancho-Garnier
This slide set will discuss the infrastructure required for a successful implementation of an HPV vaccination programme.
From the UICC - HPV and Cervical Cancer Curriculum

Chapter 5: Application of HPV vaccines
S. Garland
This presentation will guide you through the basic considerations for the development and implementation of a human papillomavirus (HPV) vaccination programme.
From the UICC - HPV and Cervical Cancer Curriculum

Chapter 4: Immunoprevention of HPV infections
M. Stanley
This module will describe how immune responses are generated, how HPV infects tissue and bypasses the immune system, and how HPV vaccines help the natural immune response.
From the UICC - HPV and Cervical Cancer Curriculum

Chapter 3: The role of HPV
Anttila, H. Vertio
This module will introduce the role, epidemiology, natural history of HPV infection and cervical lesions, risk factors and co-factors.
From the UICC - HPV and Cervical Cancer Curriculum

Chapter 2: Screening and diagnosis
2d. HPV analysis and typing

S. Garland, S. Tabrizi
This module will introduce you to the structure of the human papillomavirus and the methodology used to detect this virus.
From the UICC - HPV and Cervical Cancer Curriculum

Cervical Cytology: Techniques, classification, clinical interpretation and management guidelines
Dr G. Swarnalata
Lecture recorded at AGOICON 2008, Hyderabad

Natural history of cervical neoplasia
Dr R. Sankaranarayanan
Lecture recorded at AGOICON 2008, Hyderabad

Epidemiology of cervical cancer worldwide
Dr R. Sankaranarayanan
Lecture recorded at the XIII International federation of cervical pathology and colposcopy, Auckland New Zealand, 2008

In quest of the right technology: a decate of research into cervical screening tests
Dr R. Sankaranarayanan (IARC).

Cervical cancer: scope of the problem
Dr R. Sankaranarayanan (IARC)
Recorded presentation in Bangkok, Thailand for the 12th biennial meeting of International Cancer Society (IGCS), 25-28 October 2008.

Randomised trial of 2 versus 3 doses of HPV vaccination in India
Dr R. Sankaranarayanan (IARC)
Recorded presentation in IARC in Lyon for the Women cancer initiative of the Tata Memorial Cancer Hospital, Mumbai, India, 24-25 October 2008 meeting.

Public health issues in HPV vaccination introduction
Dr C. Sauvaget (IARC)
Recorded presentation in IARC in Lyon for the EUROGIN 2007. 4-6 October - Monte Carlo, Monaco.

Development of new cervical screening tests for use in developing countries: START project
Dr C. Sauvaget (IARC) on Behalf Dr J. Sellors (PATH)
Recorded presentation in IARC in Lyon for the EUROGIN 2007. 4-6 October - Monte Carlo, Monaco.

Rapid HPV testing: New diagnostic method in developing countries
Dr R. Sankaranarayanan
Recorded presentation in IARC in Lyon for the Seminario Internacional Aspectos Clinicos y Cientificos del Papilomavirus Humano.24, 25 Y 26 DE MAYO DE 2007, Medellin, Colombia.



More information about this project:
Rapid tests for cervical cancer


Innovation in biochemical cervical cancer screening


Innovation in cervical cancer screening
New tests offer hope for women in developing world


Picture gallery:
India - Barshi (5.31)
IARC project in Barshi, Maharastra, India (1999-2010)
IARC, 150 Cours Albert Thomas, 69372 Lyon CEDEX 08, France - Tel: +33 (0)4 72 73 84 85 - Fax: +33 (0)4 72 73 85 75
© IARC 2017 - All Rights Reserved.