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Introduction <p>In low- and middle-income countries (LMICs), cervical cancer is a major burden. Screening is mainly based on visual inspection lacking sufficient sensitivity and specificity. For roll-out of colposcopy-based early detection sufficient qualified staff is not available. Several self-sampling device products have been proposed as alternative, but their usability in primary care needs to be proven. Implementation of an HPV-based self-sampling approach in a population-based setting in Indonesia was evaluated.</p> Methods <p>Four self-sampling devices (2 urine, 2 swab) were applied in a primary care setting covering an entire district in Indonesia with Kulon Progo as pilot region. Cluster randomization was used for comparison of rural and urban areas. HPV-testing was done using standardized and validated PCR-techniques. HPV-positive women and a randomly selected HPV-negative control group underwent colposcopy, PAP smears and biopsies for cervical intraepithelial neoplasia (CIN) validation.</p> Results <p>In 21 primary care units 2056 women (30–55 y) were recruited. Three devices achieved sufficient technical validation (92.1 – 99.7% DNA detection rate). Participant’s test acceptance was 99.1%. HPV-prevalence was 2.6% (urine 2.4%, swab 2.8%). In 29.4% of HPV-positive women high-risk HPV-16/18 were detected. Colposcopy and morphological examination were refused by 3.0% of HPV-positive women and were technically invalid in 5.0%. Pathology revealed Negative for Intraepithelial Lesion or Malignancy (NILM) in 55.8%, CIN I in 25.0% and CIN II + in 3.8%. In the control group CIN I was found in 2.0%. This resulted in a sensitivity of 27.4% for all CIN and 100.0% for CIN II + , with specificities of 98.5% and 97.7%, respectively. The negative predictive values (NPV) were 97.9% and 100.0%, and positive predictive values (PPV) were 34.1% and 4.5%. Regression analysis confirmed high negative predictive impact of HPV-negativity in women &gt; 40 years.</p> Conclusions <p>Under primary care setting self-sampling-based HPV-testing is accepted. Urine- and swab-based techniques can be applied if the test systems provide technically valid DNA-detection rates. The prevalence was very low and requires further comparison within Indonesia. High NPV of this approach supports its applicability as screening in LMICs. For high-risk lesions PPV is still low suggesting a combination with additional test that are mainly independent from the availability of qualified staff.</p>

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Population-based self-sampling under primary care conditions – a possible approach for cervical cancer screening in Indonesia (IndoCerCa study)

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  • 发表日期：

    2026年5月8日

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  • Supriyatiningsih Wenang,
  • Dianita Sugiyo,
  • Sutantri Sutantri,
  • Lidia Febrianti,
  • Wiwik Kusumawati,
  • Ova Emilia,
  • Muhammad Ary Zucha,
  • Ardhanu Kusumanto,
  • Detty Siti Nurdiati,
  • Mohamad Saifudin Hakim,
  • Faizah Dwi Tirtasari,
  • Boedi Andriani Ontowiryo,
  • Pia Wilkening,
  • Peter Hillemanns,
  • Jörg Haier

摘要

Introduction

In low- and middle-income countries (LMICs), cervical cancer is a major burden. Screening is mainly based on visual inspection lacking sufficient sensitivity and specificity. For roll-out of colposcopy-based early detection sufficient qualified staff is not available. Several self-sampling device products have been proposed as alternative, but their usability in primary care needs to be proven. Implementation of an HPV-based self-sampling approach in a population-based setting in Indonesia was evaluated.

Methods

Four self-sampling devices (2 urine, 2 swab) were applied in a primary care setting covering an entire district in Indonesia with Kulon Progo as pilot region. Cluster randomization was used for comparison of rural and urban areas. HPV-testing was done using standardized and validated PCR-techniques. HPV-positive women and a randomly selected HPV-negative control group underwent colposcopy, PAP smears and biopsies for cervical intraepithelial neoplasia (CIN) validation.

Results

In 21 primary care units 2056 women (30–55 y) were recruited. Three devices achieved sufficient technical validation (92.1 – 99.7% DNA detection rate). Participant’s test acceptance was 99.1%. HPV-prevalence was 2.6% (urine 2.4%, swab 2.8%). In 29.4% of HPV-positive women high-risk HPV-16/18 were detected. Colposcopy and morphological examination were refused by 3.0% of HPV-positive women and were technically invalid in 5.0%. Pathology revealed Negative for Intraepithelial Lesion or Malignancy (NILM) in 55.8%, CIN I in 25.0% and CIN II + in 3.8%. In the control group CIN I was found in 2.0%. This resulted in a sensitivity of 27.4% for all CIN and 100.0% for CIN II + , with specificities of 98.5% and 97.7%, respectively. The negative predictive values (NPV) were 97.9% and 100.0%, and positive predictive values (PPV) were 34.1% and 4.5%. Regression analysis confirmed high negative predictive impact of HPV-negativity in women > 40 years.

Conclusions

Under primary care setting self-sampling-based HPV-testing is accepted. Urine- and swab-based techniques can be applied if the test systems provide technically valid DNA-detection rates. The prevalence was very low and requires further comparison within Indonesia. High NPV of this approach supports its applicability as screening in LMICs. For high-risk lesions PPV is still low suggesting a combination with additional test that are mainly independent from the availability of qualified staff.