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Abstract：
BACKGROUND: Good-quality artemisinin drugs are essential for malaria treatment, but increasing prevalence of poor-quality artemisinin drugs in many endemic countries hinders effective management of malaria cases.
METHODS: To develop a point-of-care assay for rapid identification of counterfeit and substandard artemisinin drugs for resource-limited areas, we used specific monoclonal antibodies against artesunate and artemether, and developed prototypes of lateral flow dipstick assays. In this pilot test, we evaluated the feasibility of these dipsticks under different endemic settings and their performance in the hands of untrained personnel.
RESULTS: The results showed that the dipstick tests can be successfully performed by different investigators with the included instruction sheet. None of the artemether and artesunate drugs collected from public pharmacies in different endemic countries failed the test.
CONCLUSIONS: It is possible that the simple dipstick assays, with future optimization of test conditions and sensitivity, can be used as a qualitative and semi-quantitative assay for rapid screening of counterfeit artemisinin drugs in endemic settings.
METHODS: To develop a point-of-care assay for rapid identification of counterfeit and substandard artemisinin drugs for resource-limited areas, we used specific monoclonal antibodies against artesunate and artemether, and developed prototypes of lateral flow dipstick assays. In this pilot test, we evaluated the feasibility of these dipsticks under different endemic settings and their performance in the hands of untrained personnel.
RESULTS: The results showed that the dipstick tests can be successfully performed by different investigators with the included instruction sheet. None of the artemether and artesunate drugs collected from public pharmacies in different endemic countries failed the test.
CONCLUSIONS: It is possible that the simple dipstick assays, with future optimization of test conditions and sensitivity, can be used as a qualitative and semi-quantitative assay for rapid screening of counterfeit artemisinin drugs in endemic settings.
摘要：
背景：优质的青蒿素药物对于治疗疟疾至关重要，但是，在许多流行国家，低质量的青蒿素药物的流行率越来越高，阻碍了对疟疾病例的有效管理。
方法：开发一种即时检测方法，用于快速识别资源有限地区的假冒和不合格青蒿素药物，我们使用了针对青蒿琥酯和蒿甲醚的特异性单克隆抗体，并开发了侧流试纸测定的原型。在这个试点测试中，我们评估了这些试纸在不同流行环境下的可行性及其在未经培训人员手中的表现。
结果：结果表明，不同的研究人员可以通过随附的说明书成功进行试纸测试。从不同流行国家的公共药房收集的蒿甲醚和青蒿琥酯药物均未通过测试。
结论：可能是简单的试纸测定，随着未来测试条件和灵敏度的优化，可用作在流行环境中快速筛选假冒青蒿素药物的定性和半定量分析方法。
方法：开发一种即时检测方法，用于快速识别资源有限地区的假冒和不合格青蒿素药物，我们使用了针对青蒿琥酯和蒿甲醚的特异性单克隆抗体，并开发了侧流试纸测定的原型。在这个试点测试中，我们评估了这些试纸在不同流行环境下的可行性及其在未经培训人员手中的表现。
结果：结果表明，不同的研究人员可以通过随附的说明书成功进行试纸测试。从不同流行国家的公共药房收集的蒿甲醚和青蒿琥酯药物均未通过测试。
结论：可能是简单的试纸测定，随着未来测试条件和灵敏度的优化，可用作在流行环境中快速筛选假冒青蒿素药物的定性和半定量分析方法。
