Advances in isothermal nucleic acid amplification-based HPV assays for cervical cancer screening in low- and middle-income countries: A scoping review

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.