Screening Of Hepatitis C Virus Infection In Inpatients And Evaluation Of A Rapid Screening Method

Hepatitis C virus(HCV)poses a serious public health problem due to its global prevalence,and the general susceptibility of all populations to HCV infection.Currently,about 71 million people worldwide are infected with HCV,but 80% of those infected patients are unaware of their infection.The increase in HCV-related deaths poses a huge economic and social burden.In 2016,the WHO has proposed a series of strategies for the complete elimination of the hepatitis virus.Therefore,the only way to achieve this goal is to identify and treat potential patients infected with HCV,simplify the HCV screening method and improve the diagnosis rate of hepatitis C.On the one hand,all hospitals conduct HCV screening for inpatients(particularly those who will undergo invasive examination and surgery)in China.However,further diagnosis and treatment are insufficient,as is the understanding of actual HCV screening.On the other hand,it is difficult to realize universal HCV screening based on laboratory tests.In order to improve the diagnosis rate and screening rate of hepatitis C,it is necessary to understand and make full use of the existing screening data in hospitals and develop a rapid,convenient and low-cost HCV screening tool.Based on the above reasons,our study carries out the following two parts of research on the strategies and methods of HCV infection screening.The first part:Aims:To understand the HCV screening of inpatients in different regions of China and put forward more valuable HCV screening strategies.Methods:We conducted a multicenter study involving eight tertiary grade-A hospitals in different regions of China.Inpatient information and HCV screening results were collected from January 2016 to December 2016 at eight tertiary grade-A hospitals.Calculate the HCV screening rate and compare the HCV-positivity of hospitalized patients from non-liver-related departments among different regions and age groups.Then calculate the number of annual screening and the number of HCV antibody positive patients that should be detected under the current policy.Finally,frame a strategy for better management of HCV-screened patients.Results:Across the eight hospitals,850,379 patients were hospitalized in 2016,of which512,938 were screened for HCV.A total of 467,008 patients(51.20% were male)treated in departments other than a liver disease department were finally included in the study.The screening rate of HCV in non-liver-related departments was over 50%.The total number of HCV antibody-positive patients was 4,129,for an HCV antibody(anti-HCV)-positive rate of 0.88%(95% confidence interval [CI],0.85%–0.91%).This rate was significantly higher among all males compared with all females(0.91% vs 0.85%).The HCV antibody-positive rate increased with age,that is,the younger the inpatients are,the lower the positive rate of anti-HCV is,which demonstrates the positive effects of related government efforts in HCV screening and prevention.Notably,90.14%(3,722/4,129)of the anti-HCV seropositive patients were 40 years of age or older and the positive rate was highest for the 60–64 year age group.The positive rate of HCV antibody in pediatric patients was the lowest(0.13%,95% CI,0.06%–0.20%),and that in oncology patients was the highest(1.80%,95% CI,1.36%–2.24%).According to the National Health Statistics Yearbook data,during 2016,the total number of inpatients in hospitals across the country was 175 million.If the HCV screening rate of other hospitals could reach 50%,the number of individuals who had received HCV screening in hospitals in 2016 was estimated at 87.5 million persons.Based on our positive rate,approximately 770,000 patients(in non-hepatic departments)who were positive for HCV antibodies could be found.Finally,a strategy based on enhanced post-screening management to improve HCV diagnosis and treatment rates was recommended.Conclusion:The screening rate of HCV among inpatients in eight tertiary grade-A hospitals was over 50%.Strengthening the management of the screened population can find more patients infected with HCV and it can effectively improve the diagnosis rate and treatment rate of hepatitis C.It is suggested that authorities should formulate relevant policies to make full use of the screening results of inpatients to help find the missing millions of patients who remain unaware and/or undiagnosed and also accelerate the elimination of HCV in China.The second part:Aims:To provide the first evaluation of the diagnostic accuracy of a new oral anti-HCV rapid test for the purpose of determining its potential utility for HCV screening and promoting the process of eliminating HCV.Methods:This multicenter study was conducted in three hospitals.The sensitivity and specificity of the Well assay were evaluated by comparing with existing laboratory methods.All participants were tested for oral HCV antibody using the Well assay and for serum HCV antibody using established tests(ARCHITECT anti-HCV assay and In Tec serum anti-HCV assay).For participants who obtained positive results,HCV RNA was tested for verification.Some patients underwent the Ora Quick HCV rapid test at the same time,and some self-tested with the Well assay during the same period.Results:A total of 1,179 participants,including 486 patients with chronic HCV infection,108 patients with other liver diseases,and 585 individuals who underwent physical examination,were enrolled.The Well anti-HCV test had a sensitivity of 91.88%(95% confidence interval[CI],88.97%–94.09%)and a specificity of 98.00%(95% CI,96.58%–98.86%)for oral HCV antibody detection,based on the results of Abbott serum HCV antibody assay.The consistency between the Well and In Tec assays was 97.02%(1,138/1,179).The consistency between the Well and Ora Quick assays was 98.50%(197/200).Furthermore,the results of self-testing were highly consistent with those of researcher-administered tests(Kappa =0.979).In addition,the HCV RNA results also showed that HCV RNA could only be detected on 1 of the 39 false-negative samples,and for 172 positive HCV RNA results,171 could be detected by the Well oral anti-HCV assay.Conclusion:The oral anti-HCV test offers high sensitivity and specificity,and its diagnostic ability can meet the needs of HCV screening.It is a rapid,noninvasive,equipment-free,inexpensive and user-friendly test,which is particularly suitable for HCV screening in community medicine as well as for self-testing at home.It is expected to be used for universal screening of HCV in the future,identifying HCV-infected patients and achieving the goal of eliminating HCV as soon as possible.