Cancer epidemiology · 2026
Advances in isothermal nucleic acid amplification-based HPV assays for cervical cancer screening in low- and middle-income countries: A scoping review.
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Mou Jin, Shashikumar Suchit, Shah Aman Kumar, Chaudhary Amit, Chakraborty Prity Lata, Yang Angelina, Shah Angira
Аннотация
OBJECTIVE: Cervical cancer disproportionately affects low- and middle-income countries (LMICs), where over 90% of deaths occur and where cost, infrastructure, and low acceptability impede the WHO 2020-2025 goal of elimination by 2030. This review synthesizes advances in isothermal nucleic acid amplification-based HPV assays (AmpFire, ScreenFire, and Sentis), together with the signal-amplification comparator careHPV, and WHO policy for cervical cancer screening in LMICs, focusing on clinical performance, implementation logistics, and alignment with the 90-70-90 elimination targets.
METHODS: A scoping review searched PubMed, Embase, Scopus, and WHO/IARC databases (January 2020 to October 2025) using MeSH terms and keywords related to isothermal amplification, HPV testing, and LMICs. Included studies evaluated assay performance, self-sampling, and program models in LMICs. Quality was assessed using the Newcastle-Ottawa Scale.
RESULTS: Isothermal assays achieve 94.7-100% sensitivity for CIN3 + and 79-98% for CIN2 +, with self-sampling and dry-swab transport enhancing access. The shift to HPV DNA testing and screen-and-treat reduces loss-to-follow-up, but specificity that varies by clinical setting, from approximately 57% in colposcopy-referral cohorts to 89-92% in general screening populations, and cultural barriers persist. Telephonic linkage improves outcomes.
CONCLUSION: Isothermal assays and WHO policies advance LMIC screening, but addressing specificity, acceptability, and cost-effectiveness is critical for the 90-70-90 targets.
METHODS: A scoping review searched PubMed, Embase, Scopus, and WHO/IARC databases (January 2020 to October 2025) using MeSH terms and keywords related to isothermal amplification, HPV testing, and LMICs. Included studies evaluated assay performance, self-sampling, and program models in LMICs. Quality was assessed using the Newcastle-Ottawa Scale.
RESULTS: Isothermal assays achieve 94.7-100% sensitivity for CIN3 + and 79-98% for CIN2 +, with self-sampling and dry-swab transport enhancing access. The shift to HPV DNA testing and screen-and-treat reduces loss-to-follow-up, but specificity that varies by clinical setting, from approximately 57% in colposcopy-referral cohorts to 89-92% in general screening populations, and cultural barriers persist. Telephonic linkage improves outcomes.
CONCLUSION: Isothermal assays and WHO policies advance LMIC screening, but addressing specificity, acceptability, and cost-effectiveness is critical for the 90-70-90 targets.