Hepatitis C is an infectious disease that results in liver disease caused by hepatitis C virus (HCV), including acute and chronic hepatitis, liver cirrhosis, and even liver cancer. The transmission route is mainly through blood transmission, input of contaminated blood, or blood products, organ transplantation, sharing of needles by drug users, etc., and the efficiency of direct body fluid transmission and sexually transmitted infection is low (1-2). From data from China’s Infectious Disease Report Information Management System, the number of HCV cases showed rapid growth from 2004 to 2011 with an average annual increase of 48.79% (3). Due to the emergence of drugs that can completely cure hepatitis C, including those based on long-acting interferons and small molecule oral drugs, the National Health Commission of China has strengthened the prevention and treatment of hepatitis C including infectious disease case reports and clinical treatment. At the end of 2012, a department dedicated to the prevention and treatment of hepatitis C was established at the National Center for STD/AIDS Prevention and Control of China CDC. Due to the implementation of ‘special disease management’ for the prevention and treatment of hepatitis C, the standardized diagnostic and reporting standards for hepatitis C, and the effectively reducing excessive and repeated reporting, the number of reports from 2012−2016 was clearly flat and stable and the growth rate was 0.65% from 2012−2016 (4). According to the “Hepatitis C Diagnostic Criteria (WS 213-2018)”, nucleic acid (HCV RNA) positive results can be diagnosed as a confirmed case and must be reported (5). According to the Law on the Prevention and Control of Infectious Diseases of the People’s Republic of China, China’s infectious disease case reporting adopts the first clinician or hospital's responsibility system. The clinician or hospital receiving the first visit is the first clinician and the first consulting hospital, and the first clinician or hospital is responsible for the diagnosis and reporting of infectious diseases of patients. Most township and community hospitals do not have the ability to diagnose infectious diseases. Therefore, the majority of county-level hospitals have become the main force of infectious disease reports in China. This study selected county-level hospitals with nucleic acid detection capabilities as survey and analysis objects. From 2013−2018, we continuously carried out verification of HCV RNA positive case reports in county-level hospitals, conducted research, and improved work through routine supervision and improved work quality.
A county-level hospital with HCV RNA detection capability was selected as a survey object, and research work was conducted in the form of work supervision. In 2013, 7 county-level hospitals in 5 provincial-level administrative divisions (PLADs) including Hebei, Henan, Hubei, Guangdong, and Yunnan were inspected; in 2014, 217 county-level hospitals in 27 PLADs (excluding Guangdong, Yunnan, Hainan, and Tibet) were inspected; in 2015, 13 county-level hospitals in 6 PLADs including Shanxi, Inner Mongolia, Anhui, Hainan, Guizhou, and Gansu were inspected; in 2016, 25 county-level hospitals in 10 PLADs of Hebei, Jilin, Heilongjiang, Shandong, Henan, Hunan, Guangxi, Guizhou, Yunnan, and Gansu were inspected; in 2017, 30 county-level hospitals in 9 PLADs of Liaoning, Shanghai, Zhejiang, Henan, Hubei, Hunan, Guangxi, Sichuan, and Qinghai were inspected; in 2018, 19 county-level hospitals in 5 PLADs of Shandong, Yunnan, Fujian, Sichuan, and Henan were inspected. The 2013−2018 inspection covered 30 PLADs except Tibet. See Table 1 for details.
Case type Antibody
Hospitalized cases 1,008 356 35.32 327 91.85 Outpatient cases 848 229 27.00 209 91.27 Total 1,856 585 31.52 536 91.62
Table 1. HCV -RNA testing of antibody positive cases in 7 inspected country hospitals in China in 2013.
In 2013 to verify hospital laboratories, we checked the RNA detection status of HCV antibody positive cases, including RNA detection rates (RNA detection number/antibody positive number) and positive rates (RNA positive number/RNA detection number). From 2013 to 2018, the laboratory of the hospital was inspected to check the HCV RNA positive list detected in the first quarter of the year. All verification was carried out when the quantity was small, and when the quantity was large, the sample was sampled by simple random sampling. The hospitals were examined on whether it had reported in the past five years from the day of the verification to the Infectious Disease Report Information Management System, and the HCV RNA positive case report rate (HCV RNA positive report number/HCV RNA positive number) was calculated. Finally, the reported cases were checked for accurately reporting confirmed cases and the accuracy of HCV RNA positive cases (HCV RNA positive report accurate number/HCV RNA positive report number) was calculated.
The examination results in 2013 showed that 585 of the 1,856 cases of HCV antibody-positive cases were tested for HCV RNA (RNA detection rate was 31.52%), and 536 were RNA-positive (RNA positive rate was 91.62%). See Table 1 for details.
From 2013 to 2018, a total of 11,946 cases that were HCV RNA positive in 30 PLADs (excluding Tibet) and 311 county hospitals were examined. The reported rates for each year from 2013−2018 were 46.83%, 52.09%, 65.59%, 53.06%, 82.10%, and 94.81%, respectively. The reported rate of HCV RNA positive cases in the 6-year average was 60.32%, which increased year by year. The accuracy rates of reports in 2013−2018 were 52.59%, 65.79%, 70.09%, 74.87%, 86.26%, and 96.12%, respectively. The accuracy rate of the 6-year average HCV RNA positive cases was 73.42%, which increased year by year. See Table 2 for details.
Year Number of PLADs* Number of county hospitals HCV-RNA positive number HCV-RNA
positive reported number
HCV-RNA positive reported rate (%) HCV-RNA
positive report accurate number
positive report accurate rate (%)
2013 5 7 536 251 46.83 132 52.59 2014 27 217 7,946 4,139 52.09 2,723 65.79 2015 6 13 247 117 47.37 82 70.09 2016 10 25 360 191 53.06 143 74.87 2017 9 30 1,933 1,587 82.10 1,369 86.26 2018 5 19 924 876 94.81 842 96.12 Total 30 311 11,946 7,206 60.32 5,291 73.42 * Provincial-level administrative divisions including provinces, autonomous regions, and municipalities.
Table 2. Report on HCV-RNA positive cases of hepatitis C in inspected county hospitals in China, 2013–2018.