Prevalence of hepatitis E virus infection among blood donors in mainland China: a meta-analysis.

BACKGROUND: The risk of hepatitis E virus (HEV) infection from blood transfusion has raised increasing concern in many countries. Several transfusion-transmitted cases have been described in the United Kingdom and Japan. The objective was to investigate the prevalence of HEV infection among Chinese blood donors and analyze the potential risk of HEV infection through blood transfusion in China. STUDY DESIGN AND METHODS: Major English and Chinese research databases were used as background research for the study of locations, years, and the number of HEV infections among blood donors in China. The pooled, estimated rate of HEV infection was calculated. Subgroup analyses, for age, sex, and alanine aminotransferase (ALT) levels were performed using software for comprehensive meta-analysis. RESULTS: The pooled rates of anti-HEV IgM- and anti-HEV IgG-positive donations were 1.09% (95% confidence interval [CI], 0.95%-1.26%) and 30% (95% CI, 25%-34%), respectively. The prevalence of anti-HEV IgM was significantly higher in donors with elevated ALT (4.34%) compared with the rate in donors with normal ALT (1.35%; χ2 = 39.66, p < 0.01). The anti-HEV IgM and IgG rates were higher in the Southwest region (1.58 and 41%, respectively) compared to the rates in other regions of China (chi-square test, p < 0.05). The anti-HEV IgG rate was also significantly higher in donors 30 years and older compared with donors between 18 and 29 years of age (39% vs. 22%, respectively; χ2 = 1457.10, p < 0.01). Genetic analysis of HEV from RNA-positive donors indicated that the majority of HEV infections were Genotype 1 (19/33 = 58%), while the remaining 14 isolates were Genotype 4 (14/33 = 42%; χ2 = 0.758, p > 0.05). CONCLUSION: Qualified donations after routine blood donor screening still carry a potential risk for transmitting HEV. The major genotypes in Chinese donors in this study were Genotypes 1 and 4.

Evaluation of an individual-donation nucleic acid amplification testing algorithm for detecting hepatitis B virus infection in Chinese blood donors.

BACKGROUND: This multicenter study was performed to evaluate the efficiency of a multiplex individual-donation nucleic acid amplification technology (ID-NAT) and discriminatory testing algorithm for detecting hepatitis B virus (HBV) infection in Chinese blood donors. STUDY DESIGN AND METHODS: A total of 1,205,796 hepatitis B surface antigen (HBsAg)-nonreactive donations from 10 blood centers were tested by ID-NAT using the Ultrio assay. Multiplex Ultrio-reactive donations were tested in the discriminatory tests as well as in quantitative polymerase chain reaction (qPCR) and in supplemental electrochemiluminescence immunoassays for HBsAg, hepatitis B surface antibody (anti-HBs), hepatitis B e antigen, and antibody to hepatitis B core antigen (anti-HBc). Meanwhile, a control group of 4317 Ultrio-nonreactive donations was tested for anti-HBc and anti-HBs. RESULTS: Of all donations, 2033 (0.17%) were reactive in the multiplex Ultrio assay. Among 1776 further tested samples, 548 (30.9%) were HBV discriminatory assay (dHBV)-reactive, while 1214 (68.4%) were nonreactive. Of 472 Ultrio+ and dHBV+ samples 86.2% were qPCR positive compared to 15.0% in 1046 Ultrio+ and dHBV- samples. The proportion of anti-HBc+ and anti-HBs- (potentially infectious) donations was higher in 409 Ultrio+ and dHBV+ than in 1028 Ultrio+ and dHBV- samples (51.3% vs. 31.1%, p < 0.001). The yield rate of Ultrio+, dHBV+, and qPCR+ donations was estimated at 1 in 2500, but at 1 in 1100 when all supplemental tests were taken into account assuming that 44% of detected donations by Ultrio were false reactive. CONCLUSIONS: A quarter of HBsAg-negative Ultrio+ and dHBV- donations in China are likely given by potentially infectious low-viral-load occult carriers. Although this has no implication for blood safety, the testing algorithm needs to be redesigned to more efficiently discriminate between true and false NAT reactivity.

Routine screening of blood donations at Qingdao central blood bank, China, for hepatitis B virus (HBV) DNA with a real-time, multiplex nucleic acid test for HBV, hepatitis C virus, and human immunodeficiency virus Types 1 and 2.

BACKGROUND: The Roche cobas TaqScreen MPX test was used to evaluate the rate of hepatitis B surface antigen (HBsAg)-negative donations that were hepatitis B virus (HBV) DNA reactive from June 2010 to January 2011 in Qingdao, China. STUDY DESIGN AND METHODS: HBsAg-negative samples from 65,800 voluntary blood donors were tested with the cobas TaqScreen MPX test in pools of 6 on the Roche cobas s 201 blood screening platform. Samples positive for HBV DNA and negative for HBsAg were quantitated with the Roche COBAS AmpliPrep/COBAS TaqMan HBV test. In addition, serologic tests for HBsAg, hepatitis B surface antibody, anti-hepatitis B core antigen (anti-HBc), anti-hepatitis B e antigen (anti-HBe), and hepatitis B e antigen (HBe) were done using the Roche electrochemiluminescence immunoassay. RESULTS: A total of 80 nucleic acid amplification technology (NAT) test-reactive pools were identified and 59 pools (74%) resolved to a reactive sample. All samples were HBV DNA reactive and the viral load in each sample was quantitated. The viral loads of the samples ranged from less than 20 to 34,600 IU/mL; 13 samples (22%) had viral loads of more than 20 IU/mL, 27 samples (45.8%) had viral loads of less than 20 IU/mL, and 19 samples (32.2%) had undetectable viral loads. Of the 59 NAT-reactive samples, 40 (67.8%) were anti-HBc positive. Fifteen of the 59 samples could not be confirmed as NAT reactive either by an alternative NAT test or by serology. CONCLUSION: The HBV NAT yield in blood donors in Qingdao is 0.06% (38/65,800). This study confirmed the value of NAT for interdicting HBV-positive donations and preventing transfusion-transmitted HBV infections.