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

Abstract

BackgroundReplacement of cytology screening with HPV testing is recommended and essential for cervical cancer elimination. HPV testing for primary screening was implemented in 12 laboratories within 9 Latin American countries, as part of the ESTAMPA cervical cancer screening study. Our observations provide information on critical operational aspects for HPV testing implementation in diverse resource settings.MethodsWe describe the implementation process of HPV testing in ESTAMPA, focusing on laboratory aspects. We assess the readiness of 12 laboratories to start HPV testing and their continuity capacity to maintain good quality HPV testing until end of recruitment or up to December 2021. Readiness was based on a checklist. Information from the study database; regular meetings and monitoring visits; and a questionnaire on laboratory operational aspects sent in May 2020 were used to assess continuity capacity. Compliance with seven basic requirements (readiness) and eight continuity requirements (continuity capacity) was scored (1 = compliant, 0 = not compliant) and totaled to classify readiness and continuity capacity as very limited, limited, moderate or high. Experiences, challenges, and enablers of the implementation process are also described.ResultsSeven of 12 laboratories had high readiness, three moderate readiness, and of two laboratories new to HPV testing, one had limited readiness and the other very limited readiness. Two of seven laboratories with high readiness also showed high continuity capacity, one moderate continuity capacity, and the other four showed limited continuity capacity since they could not maintain good quality HPV testing over time. Among three laboratories with moderate readiness, one kept moderate continuity capacity and two reached high continuity capacity. The two laboratories new to HPV testing achieved high continuity capacity. Based on gained expertise, five laboratories have become part of national screening programs.ConclusionHigh readiness of laboratories is an essential part of effective implementation of HPV testing. However, high readiness is insufficient to guarantee HPV testing high continuity capacity, for which a “culture of quality” should be established with regular training, robust monitoring and quality assurance systems tailored to local context. All efforts to strengthen HPV laboratories are valuable and crucial to guarantee effective implementation of HPV-based cervical screening.

Cervical Cancer Screening Recommendations: Now and for the Future

“…In even the most developed nations, reaching an entire population is difficult due to unequal distribution of access to resources [ 64 ]. Significant infrastructure is necessary to support a screening method [ 65 ]. Most HPV testing requires approved testing kits consisting of sample collection materials, specimen storage medium, and a method to transport samples to the appropriate laboratory for processing [ 39 ].…”

“…The production, availability, and use of non-approved HPV tests may theoretically reach a wider population but are not preferable due to potential poor clinical validity; providers should aim to offer and utilize approved HPV tests for screening. Each of the numerous internationally approved HPV tests requires the appropriate structural support to process samples on a large scale for a community [ 36 , 65 ]. A newer alternative to the commonly used HPV testing laboratory approach is the use of point-of-care HPV testing, with processing on a smaller-scale clinic basis rather than central laboratory structure.…”

“…Similarly, cotesting with cervical cytology and HPV testing is still performed, which may be indicative of the historical influence that the traditional Pap smear has had due to its longstanding position as the quintessential cervical cancer screening method [ 56 , 60 , 69 ]. This delay in shift to HPV testing seen may be due to a lag of HPV testing infrastructure [ 65 ]. It takes significant time and funding to set up the support required for a new screening method on a national or even regional scale, particularly when one functioning system such as that supporting Pap smear screening is already in place [ 69 ].…”

“…Less-developed countries often have limited access to the resources required to carry out HPV testing or cervical cytology on a large scale [ 29 , 65 ]. Where these modalities are not available, often times VIA becomes the test of choice for cervical cancer screening [ 71 ].…”

Performance of cervical cytology and HPV testing for primary cervical cancer screening in Latin America: an analysis within the ESTAMPA study

“…Local laboratories had regular participation in External Quality Assessment [either the College of Pathologists (CAP) scheme or the Quality Control for Molecular Diagnostics (QCMD)] and maintained good laboratory practices, including facilities and suitable laboratory environment, stock of reagents, equipment and staff competence as previously described in ESTAMPA. 12 …”