Progress in the application of isothermal amplification technology in the diagnosis of infectious diseases

Qingshang Bi¹Mengru Liu^2,3Li Yan⁴Jun Cheng³Qingyang Sun³Yuzhu Dai^3*Lingli Zou^1*

• ¹Department of Clinical laboratory of the Third Sanitarium Area, Air Force HealthCare Center for Special Services Hangzhou, Hangzhou, Jiangsu Province, China
• ²School of Laboratory Medicine, Bengbu Medical College, Bengbu, Anhui Province, China
• ³Department of Clinical laboratory, The 903rd Hospital of The Chinese People’s Liberation Army, Hangzhou, Jiangsu Province, China
• ⁴Department of Health Economic, The 903rd Hospital of The Chinese People’s Liberation Army, Hangzhou, Jiangsu Province, China

Rapid detection of infectious diseases is critical for global public health prevention and control.However, the use of traditional molecular diagnostic methods, including PCR, has been limited because of their cumbersome procedures, complex equipment requirements, operation at different temperatures, and the level of expertise required for operation. Isothermal amplification technology (IAT) provides a rapid, sensitive, specific, simple and less costly method for diagnosing infectious diseases, which has led to revolutionary breakthroughs in molecular diagnostics. This paper summarizes recent progress in IAT technology, which focuses on the principles and applications of core technologies such as NASBA, LAMP, RPA, and RAA. In addition, the combination of IATs with the CRISPR/Cas system, which further revolutionizes nucleic acid detection technology, is explored in this review.Infectious diseases, as defined as pathological disorders caused by invasive pathogenic microorganisms including bacteria, viruses, fungi, and parasites, continue to pose significant threats to global public health. These conditions are clinically distinguished from noncommunicable diseases by their transmissible nature and external pathogenic origin. Globally, infectious disease remains a leading cause of death and disability and a growing challenge to health security and human progress (Nii-Trebi, 2017). According to the World Health Organization (WHO), 13 million people died from communicable diseases in 2021, and people in low-and middle-income countries are far more likely to die from communicable diseases than from noncommunicable diseases(WHO 2021). Rapid diagnosis of infectious diseases is critical to stop their spread. Although traditional molecular diagnostic techniques (such as PCR) are highly sensitive, their dependence on thermal cyclers,