An integrated isothermal nucleic acid amplification test to detect HPV16 and HPV18 DNA in resource-limited settings

环介导等温扩增 注意事项 检测点注意事项 仪表(计算机编程) 计算机科学 考试(生物学) 宫颈癌 医学 资源(消歧) 计算生物学 癌症 DNA 生物 病理 内科学 遗传学 操作系统 古生物学 计算机网络
作者
Kathryn A. Kundrod,Maria Barra,Alexis F. Wilkinson,Chelsey Smith,Mary E. Natoli,Megan M. Chang,Jackson B. Coole,Akshaya Santhanaraj,Cesaltina Lorenzoni,Celda Mavume,Hira Atif,Jane R. Montealegre,Michael E. Scheurer,Philip E. Castle,Kathleen M. Schmeler,Rebecca Richards‐Kortum
出处
期刊:Science Translational Medicine [American Association for the Advancement of Science (AAAS)]
卷期号:15 (701) 被引量:11
标识
DOI:10.1126/scitranslmed.abn4768
摘要

High-risk human papillomavirus (HPV) DNA testing is widely acknowledged as the most sensitive cervical cancer screening method but has limited availability in resource-limited settings, where the burden of cervical cancer is highest. Recently, HPV DNA tests have been developed for use in resource-limited settings, but they remain too costly for widespread use and require instruments that are often limited to centralized laboratories. To help meet the global need for low-cost cervical cancer screening, we developed a prototype, sample-to-answer, point-of-care test for HPV16 and HPV18 DNA. Our test relies on isothermal DNA amplification and lateral flow detection, two technologies that reduce the need for complex instrumentation. We integrated all test components into a low-cost, manufacturable platform, and performance of the integrated test was evaluated with synthetic samples, provider-collected clinical samples in a high-resource setting in the United States, and self-collected clinical samples in a low-resource setting in Mozambique. We demonstrated a clinically relevant limit of detection of 1000 HPV16 or HPV18 DNA copies per test. The test requires six user steps, yields results in 45 min, and can be performed using a benchtop instrument and minicentrifuge by minimally trained personnel. The projected per-test cost is <$5, and the projected instrumentation cost is <$1000. These results show the feasibility of a sample-to-answer, point-of-care HPV DNA test. With the inclusion of other HPV types, this test has the potential to fill a critical gap for decentralized and globally accessible cervical cancer screening.
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