Evaluation of Seven Rapid Diagnostic Tests for Detection of Hepatitis C Virus Antibodies in China

Bing Chen; Zhong-Hui Ma; Bing Xu; Hao Chang; Xiao-Xia He; Li-Jian Pei; Ya-Nan Ren; Wen-Ge Xing


J Viral Hepat. 2021;28(4):657-663. 

In This Article

Abstract and Introduction


Rapid diagnostic tests as an attractive alternative to enzyme immunoassay could identify hepatitis C virus (HCV) infected persons more expeditiously. The availability of high performing and quality-assured rapid diagnostic tests are essential to scale-up HCV screening. The study was undertaken to evaluate the performance of seven domestic HCV rapid diagnostic tests kits. The kits were evaluated by using HCV serum panels, including HCV basic panel, analytical specificity panel, mixed titre performance panel, characteristic panel, seroconversion panel, and genotype qualification panel. The results showed that clinical sensitivity, clinical specificity and analytical specificity of seven rapid diagnostic tests kits ranged from 94% (95% CI: 83.2–98.6) to 100% (95% CI: 91.5–100). Furthermore, specimens with HCV genotypes 1b, 2a, 3a, 4a, 5a, 6 could be detected by HCV rapid diagnostic tests kits, whereas specimens with genotypes 1a and 2b could not be detected. Additionally, most HCV rapid diagnostic tests kits had great performance in diagnosing different titres and/or different bands samples, but some low S/CO value specimens may not be fully detected by few rapid diagnostic test kits. In conclusion, seven HCV rapid diagnostic tests reagents presented high sensitivity, specificity, good anti-interference and detection ability of early infection, which could meet the requirements of clinical HCV antibody screening.


Hepatitis C virus (HCV) infection constitutes a global public health problem and a leading cause of chronic hepatitis, cirrhosis, and hepatocellular carcinoma.[1,2] Moreover, HCV infection is also a major contributor to mortality and morbidity worldwide.[3–5] In China, the prevalence of HCV is approximately 3%. It is estimated that grand total of 40 million individuals are infected with HCV in mainland China, and are one of the largest numbers of HCV infection in the world.[6,7] While most of persons with HCV infection are unaware of their infection status.[8,9] Therefore, large scale screening is critical to the success of HCV elimination targets, and early diagnosis and treatment of HCV infection are essential to prevent disease progression.

Conventional HCV testing is usually based on serological tests, including HCV-specific antibodies detection by means of chemiluminescent immunoassay (CLIA) or enzyme-linked immunosorbent assay (ELISA), performed in laboratories.[10] However, ELISA and CLIA assays are expensive, have long turnaround times, and require well-trained staff and well-equipped laboratory.[9] In contrast, rapid diagnostic tests (RDTs) represent an attractive alternative for HCV screening and diagnosis, using various matrices, including serum and plasma, but also fingerstick capillary whole blood or oral fluid. Additionally, RDTs offer the advantage of simplicity, minimal training required, limited need for instrumentation, and rapid performance at room temperature.[10]

The objective of this study was to evaluate the performances of seven HCV RDTs approved by Chinese Food and Drug Administration (CFDA) HCV RDTs for the detection of HCV antibodies using multiple serum panels, and to provide references for testing selection in clinical application.