Odiwuor Nelson, Li Junhua, He Ping, Wang Nuo, Murtaza Ali, Jiang Mengwei, Yu Junping, Wei Hongping
WHP Innovation Lab, Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, Hubei 430207, China; University of Chinese Academy of Sciences, Beijing, 100049, China; Sino-Africa Joint Research Centre, Nairobi, 62000 - 00200, Kenya.
WHP Innovation Lab, Wuhan Institute of Virology, Chinese Academy of Sciences, Wuhan, Hubei 430207, China.
Talanta. 2025 Feb 1;283:127119. doi: 10.1016/j.talanta.2024.127119. Epub 2024 Nov 4.
The rapid and accurate detection of viral infections is essential for effective disease management and prevention. Quantitative polymerase chain reaction (qPCR) remains the gold standard for viral detection due to its high sensitivity and specificity. However, its limitations-including the need for specialized equipment, trained personnel, and longer processing times-make it impractical for at-home or rapid testing. Although numerous point-of-care assays based on isothermal nucleic acid amplification have been developed, they often lack the simplicity and adaptability required for self-testing in non-laboratory settings such as at home. To address this, we developed and validated the SCOLAR (Shelf-stable Colorimetric LAMP system for Rapid self-testing of viruses) system, a simplified, portable, and accurate diagnostic tool designed for self-testing of Mpox and SARS-CoV-2 infections. The SCOLAR system employs novel lyophilized colorimetric loop-mediated isothermal amplification (LAMP) beads, a customized sample lysis buffer, and smartphone-assisted RGB color analysis for interpreting results. Validation was conducted using 24 mock Mpox skin swabs, 32 wastewater samples, and 104 clinical SARS-CoV-2 nasopharyngeal swabs, with comparisons to an in-house qPCR assay. The SCOLAR system demonstrated an analytical sensitivity of below 10 copies/μL for all targets within 15 min. Diagnostic performance for mock Mpox samples exhibited 93.8 % sensitivity and 100 % specificity, while wastewater samples achieved 100 % sensitivity and specificity. SARS-CoV-2 swabs had 96 % sensitivity and 100 % specificity. The system also proved effective for self-testing by untrained individuals. SCOLAR offers a reliable, easy-to-use platform for rapid self-testing, with potential for broader applications in public health strategies to enhance pandemic preparedness and response.
快速准确地检测病毒感染对于有效的疾病管理和预防至关重要。定量聚合酶链反应（qPCR）由于其高灵敏度和特异性，仍然是病毒检测的金标准。然而，它的局限性——包括需要专门设备、训练有素的人员以及较长的处理时间——使得它在家庭或快速检测中不切实际。尽管已经开发了许多基于等温核酸扩增的即时检测方法，但它们往往缺乏在非实验室环境（如家中）进行自我检测所需的简便性和适应性。为了解决这个问题，我们开发并验证了SCOLAR（用于病毒快速自我检测的货架稳定比色LAMP系统）系统，这是一种简化、便携且准确的诊断工具，专为猴痘和严重急性呼吸综合征冠状病毒2（SARS-CoV-2）感染的自我检测而设计。SCOLAR系统采用新型冻干比色环介导等温扩增（LAMP）珠、定制的样品裂解缓冲液以及智能手机辅助的RGB颜色分析来解读结果。使用24份模拟猴痘皮肤拭子、32份废水样本和104份临床SARS-CoV-2鼻咽拭子进行了验证，并与内部qPCR检测进行了比较。SCOLAR系统在15分钟内对所有靶标的分析灵敏度低于10拷贝/微升。模拟猴痘样本的诊断性能显示灵敏度为93.8%，特异性为100%，而废水样本的灵敏度和特异性均达到100%。SARS-CoV-2拭子的灵敏度为96%，特异性为100%。该系统还被证明对未经训练的个体进行自我检测有效。SCOLAR为快速自我检测提供了一个可靠、易于使用的平台，在公共卫生战略中具有更广泛应用的潜力，以加强大流行防范和应对。
