Implementing HPV testing in 9 Latin American countries: The laboratory perspective as observed in the ESTAMPA study

Area of Science:

• Oncology
• Public Health
• Laboratory Medicine

Background:

• Cervical cancer elimination strategies increasingly recommend replacing cytology with human papillomavirus (HPV) testing.
• The ESTAMPA study implemented primary HPV testing in 12 laboratories across 9 Latin American countries.
• This study provides insights into operational aspects of HPV testing implementation in diverse resource settings.

Purpose of the Study:

• To describe the implementation process of HPV testing within the ESTAMPA study, with a focus on laboratory operations.
• To assess the initial readiness and long-term continuity capacity of participating laboratories for HPV testing.
• To identify challenges and enablers in establishing HPV testing services in resource-limited settings.

Main Methods:

• Readiness was evaluated using a checklist for 12 laboratories.
• Continuity capacity was assessed through study data, monitoring visits, and a questionnaire on operational aspects.
• Laboratory performance was scored based on compliance with readiness and continuity requirements.

Main Results:

• Seven laboratories demonstrated high readiness, while three had moderate readiness. Two new laboratories showed limited to very limited readiness.
• High initial readiness did not always translate to sustained high continuity capacity.
• Laboratories with moderate readiness and those new to HPV testing achieved high continuity capacity, with five laboratories integrated into national screening programs.

Conclusions:

• High laboratory readiness is essential but insufficient for ensuring sustained high-quality HPV testing.
• Establishing a "culture of quality" through training, monitoring, and tailored quality assurance is critical for continuity.
• Strengthening HPV testing laboratories is vital for the effective implementation of HPV-based cervical screening programs.