Xiaoxu Han1, Jinming Li2, Yu Chen3, Yan Li4, Yingchun Xu5, Binwu Ying6, Hong Shang7. 1. National Clinical Research Center for Laboratory Medicine, Department of Clinical Laboratory, The First Affiliated Hospital of China Medical University, Shenyang, 110001, China. 2. National Center for Clinical Laboratories, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital, National Center of Gerontology, Beijing, China. 3. Department of Clinical Laboratory, The First Affiliated Hospital, Zhejiang University, Hangzhou, China. 4. Department of Clinical Laboratory, People's Hospital of Wuhan University, Wuhan, China. 5. Department of Clinical Laboratory, Peking Union Medical College Hospital, Beijing, China. 6. Department of Clinical Laboratory, West China Hospital of Sichuan University, Chengdu, China. 7. National Clinical Research Center for Laboratory Medicine, Department of Clinical Laboratory, The First Affiliated Hospital of China Medical University, Shenyang, 110001, China. Electronic address: hongshang100@hotmail.com.
WHO states that timely and accurate diagnostic testing is an essential tool in preventing and controlling the spread of COVID-19. With a huge and densely distributed population, China developed a national SARS-CoV-2 nucleic acid testing strategy that has had a pivotal role in containing COVID-19. This strategy involved border entry screening, inpatient screening, rapid screening in fever clinics, and mass screening of the population in an epidemic area.China began developing SARS-CoV-2 nucleic acid detection kits soon after the initial outbreak of COVID-19 in Wuhan at the end of 2019. By Jan 31, 2020, the National Medical Products Administration urgently approved six nucleic acid detection kits, and post-market evaluation with a multicentre clinical trial was completed by professional institutions by the end of February, 2020. The sensitivity of these kits was 55·3–95·7%, the specificity above 98% (unpublished).A national nucleic acid amplification testing (NAAT) laboratory network was also quickly established. NAAT laboratories have been in development across China for decades; thousands of NAAT laboratories for detecting infectious agents such as hepatitis B virus, hepatitis C virus, and HIV are established in large hospitals, blood centres, and in the Chinese Center for Disease Control and Prevention. As of Feb 14, 2022, 12 777 NAAT laboratories (four times more than at the beginning of the COVID-19 pandemic) provide strong support for infectious diseases diagnosis, treatment, and prevention (appendix). For every 1 million permanent urban residents, hospitals are equipped with at least one routine testing laboratory with capacity to analyse 10 000 samples per day.Professional education and technical training opportunities are also continuously provided to the laboratory staff by the National Center for Clinical Laboratories. Nationwide external quality assessment programmes are organised regularly for all testing laboratories (appendix).To detect COVID-19 outbreaks early and protect patients from getting infected in hospitals, all secondary and tertiary hospitals across China have fever clinics that provide services 24 h per day, 7 days a week. Fever clinics have been encouraged to acquire rapid SARS-CoV-2 testing tools that deliver results within 4–6 h and enable the timely identification of infections.China continues its population-based mass screening strategy to support the dynamic zero-COVID-19 policy. To implement such large-magnitude screening within epidemic areas in a short timeframe, routine testing laboratories in hospitals and public testing laboratories (including mobile laboratories and technical staff from surrounding neighbourhoods) can be mobilised urgently by the government. By the end of 2020, 100 mobile laboratories with a capacity to analyse 10 000 samples had been built, enabling a flexible testing reserve capacity of 1 million samples per day nationwide. Other large-scale and qualified independent clinical laboratories also participate in this mass screening strategy to accelerate sample testing turnover in every local epidemic area.To improve the efficiency of mass screening, China has adopted the sample pooling strategy in three patterns (five, ten, or 20 pooled samples) on the basis of different epidemic periods.4, 5 With the optimisation of sample pooling methodology and development of an electronic information system, this sample pooling strategy ensures both high sensitivity and efficiency.The cost of routine SARS-COV-2 testing during hospitalisation and in fever clinics, as well as the mass screening during an epidemic, are covered by basic medical insurance or by the government. These measures enable large cities with a population of 10 million people or more to complete SARS-CoV-2 testing within 24–48 h, without substantially affecting routine clinical services.The SARS-CoV-2 testing strategy has not only improved the containment of COVID-19 but also contributes to the control of other infectious diseases, such as HIV and human papillomavirus, and non-communicable diseases. China's COVID-19 response has accelerated its diagnostics agenda and testing capacity. To further optimise the COVID-19 detection strategy, China recently decided to supplement the existing strategy with antigen detection, and we will continue to accelerate technological innovation and develop the testing reagents for communities and remote areas. Ensuring universal access to diagnostics via effective and rapid testing is essential for the preparations for future pandemics.This online publication has been corrected. The corrected version first appeared at thelancet.com on April 13, 2022HS is director of the National Clinical Research Center for Laboratory Medicine, which provides technical support for the national strategy of COVID-19 testing. All other authors declare no competing interests.