Impact of operational factors on HPV positivity rates in an HPV‐based screening study in Colombia

Robles, Claudia; Wiesner, Carolina; Martínez, Sandra; Salgado, Yuly; Hernández, Manuel Hernández; Lucas, Eric; Lineros, Johana; Romero, Pilar; Herrero, Rolando; Almonte, Maribel; Murillo, Raúl

doi:10.1002/ijgo.12574

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“…In one center, samples from the first 900 recruited women were stored in the Digene Standard Transport Medium (STM) and subsequently tested with HC2. In this center, a sub-study evaluating the impact of operational factors on HPV positivity of HPV assays including HC2, COBAS and APTIMA (Hologic, USA) was conducted and COBAS results were assumed as QC of HC2 and APTIMA ( 35 ).…”

Section: Methodsmentioning

confidence: 99%

“…In the World Health Assembly (20) adopted a global strategy for eliminating cervical cancer as a public health problem. In order to reach elimination by the end of the century, countries should achieve full vaccination of 90% of girls by age 15, screening of 70% of women twice by age 35 and 45 with a high-performance test, and treatment of 90% of women with cervical disease (precancer or invasive cervical cancer) (21). In 2021, WHO published cervical cancer screening and treatment guidelines recommending the use of HPV DNA detection in a screen and treat approach or a screen, triage and treat approach starting at age 30 every 5 to 10 years for the general population, and using HPV DNA detection in a screening, triage and treat approach starting at age 25 every 3 to 5 years for women living with HIV (22).…”

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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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.

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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

et al. 2022

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Impact of operational factors on HPV positivity rates in an HPV‐based screening study in Colombia

Abstract: Nurse expertise, collection of previous cytology, processing time, and laboratory technician could influence HPV assay performance. Suitable quality assurance protocols for HPV-based screening programs are required. ClinicalTrials.gov: NCT01881659.

Cited by 1 publication

References 19 publications

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

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

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