Hepatitis C virus prevalence and incidence estimates among Chinese blood donors.

BACKGROUND: Hepatitis C virus (HCV) is an important transfusion-transmitted virus with global significance. The objective of this study was to evaluate the HCV prevalence and incidence among Chinese blood donors from 2013 to 2016. STUDY DESIGN AND METHODS: Whole blood and apheresis platelet donations collected from five Chinese blood centers from June 1, 2013, to December 31, 2016, were screened in parallel by two different enzyme-linked immunosorbent assays for anti-HIV 1/2, hepatitis B surface antigen, anti-HCV, and syphilis. Screening-reactive samples were further confirmed by western blot. Confirmatory positive rates among first-time and repeat donors were used to estimate the prevalence and incidence rates. Multivariable logistic regression modeling was used to examine factors associated with HCV infection. RESULTS: A total of 1,276,544 donations were collected from five Chinese blood centers, of which an estimated 1203 were confirmed HCV positive. The overall HCV prevalence among first-time donors was 166.56 per 100,000 donors (95% confidence interval, 156.04-177.08). The HCV incidence rate was estimated to be 15.21 (95% confidence interval, 11.83-19.56) per 100,000 person-years among repeat donors. Multivariable logistic regression results showed that increased age, lower educational levels, ethnicity, and occupation were all important factors associated with HCV confirmatory status among first-time donors (p < 0.01). CONCLUSIONS: HCV infection is still an important concern for transfusion safety in China. Our findings indicate that continued strong efforts are needed to monitor and control the risk of transfusion-transmitted HCV infection in China. Moreover, to reduce unnecessary donor loss, HCV donor screening procedures should be improved by incorporating confirmatory testing into routine blood center operations.

Risk factors for hepatitis B and C infection among blood donors in five Chinese blood centers.

BACKGROUND: Few studies were conducted on hepatitis B and C virus (HBV and HCV, respectively) risk factors among Chinese blood donors in recent years since voluntary donors replaced commercial donors. STUDY DESIGN AND METHODS: A case-control survey was conducted in HBV- or HCV-positive and -negative donors from five blood centers in China between September 2009 and April 2011. Case status was defined by having a reactive result on Monolisa HBsAg Ultra (Bio-Rad) for HBV and Ortho anti-HCV EIA 3.0 (Johnson & Johnson) for HCV. Controls were randomly selected qualified blood donors matched to cases by donation month and blood center. Specific test-seeking, medical-related, and behavioral risk factors were compared by HBV and HCV status using chi-square tests or Fisher's exact tests with Bonferroni correction. RESULTS: A total of 364 HBV cases, 174 HCV cases, and 689 controls completed the survey; response rates were 66.2, 47.3, and 82%, respectively. HCV-positive donors were significantly more likely to report having a blood transfusion history (23.4% vs. 3.0%, p < 0.0001) and ever living with a person with illegal drug injection (6.0% vs. 0.5%, p < 0.0001) than controls. Having intravenous and intramuscular injections in the past 12 months and ever having a tattoo are marginal risk factors for HCV (p values < 0.01). No specific risk factor for HBV was identified. CONCLUSION: History of previous transfusion and living with illegal drug users are risk factors for HCV infection among Chinese blood donors from five regions. Test-seeking behavior is not associated with HBV or HCV infections.

Long-term return behavior of Chinese whole blood donors.

BACKGROUND: It is important to understand donor return behavior to maintain sufficient numbers of blood donors in developing countries where blood supplies are often inadequate. STUDY DESIGN AND METHODS: A total of 54,267 whole blood (WB) donors who donated between January 1 and March 31, 2008, at the five blood centers in China were followed for 2.5 years. Logistic regression was conducted to identify factors associated with their return behavior. A recurrent-event Cox proportional-hazard model was used to evaluate the overall effect of demographic variables and return behavior among first-time donors. RESULTS: Donors with previous donation history were more likely to return and the number of previous returns was positively associated with future return (odds ratios, 3.31, 4.82, and 8.16 for one, two to three, and more than three times compared to none). Thirty-four percent of donors (first-time donor, 21%; repeat donor, 54%) made at least one return donation, with 14% returning in the first 9 months. The multivariable logistic regression model for all WB donors and the Cox proportional hazard model for first-time donors showed consistent predictors for return: female sex, older age (≥ 25 years), larger volume (300 or 400 mL), and donating in satellite collection site. CONCLUSION: Encouraging first-time donors to make multiple donations is important for keeping adequate blood supply. The finding that first-time and repeat donors shared the same predictors for return indicates that retention strategies on repeat donors may be effective on first-time donors. Studies on motivators and barriers to return are needed, so that successful retention strategies can be tailored.

The prevalence of human parvovirus B19 DNA and antibodies in blood donors from four Chinese blood centers.

BACKGROUND: Human parvovirus B19 is a common human pathogen that causes a variety of diseases with outcomes ranging from asymptomatic to severe, especially in immunocompromised patients. The B19 virus can be transmitted via blood and/or blood products and its resistance to common viral inactivation and/or removal methods raises the importance of B19-related blood safety. However, the existence, variation, and loading of B19 in Chinese blood donors have not been determined. STUDY DESIGN AND METHODS: Quantitative polymerase chain reaction (PCR) was developed to detect all three genotypes of the human erythrovirus DNA in plasma samples. In total, 3957 donations from four Chinese blood centers were screened for B19 by real-time minipool nucleic acid amplification technology (NAT). The positive samples were then confirmed by nested PCR and subjected to sequence analysis and alignment for phylogenetic studies. An enzyme-linked immunosorbent assay-based experiment was also performed to identify the prevalence of immunoglobulin (Ig)G and/or IgM antibodies specific to the B19 structural proteins in acquired samples. RESULTS: Of 3957 blood donors, 23 (0.58%) specimens were found positive for B19 DNA. The quantitative DNA levels ranged from 2.48 × 10(2) to 6.38 × 10(4) copies/mL. The phylogenic analyses showed that the prevalent genotypes in Chinese blood donors belong to B19 Genotype 1. A total of 448 samples from Chinese blood donors were investigated for the seroprevalence of B19 antibodies, among which 24.6 and 6.9% of specimens were seropositive for B19 IgG and IgM antibodies, respectively. A total of 2.5% of these samples were positive for both antibody isotypes. CONCLUSIONS: Whether B19 NAT screening of blood and blood products should be launched in China, larger studies are needed to facilitate an informed decision.

Hepatitis B virus nucleic acid testing in Chinese blood donors with normal and elevated alanine aminotransferase.

BACKGROUND: Nucleic acid testing (NAT) is currently not a routine donor test in China. The aim of this study was to evaluate the current residual risk of hepatitis B virus (HBV) transmission and the value of ALT testing in preventing HBV infection. STUDY DESIGN AND METHODS: From January 2008 to September 2009, a total of 5521 qualified donations by routine screening and 5034 deferred donations due to elevated ALT alone were collected from five blood centers. Samples were tested for HBV DNA by triplex individual-donation (ID)-NAT (ULTRIO assay, on the TIGRIS system, Novartis Diagnostics). HBV NAT-reactive samples were further analyzed by HBV serology, alternative NAT, and viral load and were diluted to simulate if they could be detected in a minipool-NAT. RESULTS: There was no significant difference in the HBV NAT-yield rate between the qualified donations group (5/5521) and the deferred donations group (4/5034). Of these nine potential HBV-yield cases, one donor (11%) was a possible HBV window-period donor, one (11%) was a chronic HBV carrier, and seven (78%) had probable or confirmed occult HBV infections. Of seven potential HBV-yield cases quantified, the viral loads were less than or equal to 70.0 IU/mL. Minipool testing (minipools of 4, 8, and 16 donations) would miss 43% to 79% of the nine HBV-yield donations. CONCLUSIONS: Based on our findings in qualified donations, we estimate that the nationwide implementation of ID-NAT testing for HBV DNA in China would detect an additional 9964 viremic donations per year. ALT testing seems to have no significant value in preventing transfusion-transmitted HBV infection. ID-NAT versus simulated minipool-NAT using the ULTRIO test demonstrates the benefit to implement a more sensitive NAT strategy in regions of high HBV endemicity.

Hepatitis C virus genotype/subtype distribution and evolution among Chinese blood donors: Revealing recent viral expansion.

Hepatitis C virus (HCV) genotype (GT) distribution in China shows significant geographical and demographic difference. As a routinely tested virus in Chinese blood bank systems, rare molecular epidemiology research in blood donors is reported. Our purpose is to investigate the HCV GT/subtypes distribution, phylogenetic analysis and population genetics in Chinese blood donors. Anti-HCV screen positive samples and donor demographics were collected. HCV Core and E1 gene fragments were amplified by RT-PCR, followed by sequencing and phylogenetic analysis to determine HCV GTs/subtypes using MEGA 7.0. The population genetics were performed using Arlequin v3.0 and Beast v1.10.4. SPSS Statistics 17.0 software was used to analyze the correlation between HCV GTs/subtypes distribution and demographic characteristics. 419 and 293 samples based on Core and E1 gene respectively were successfully amplified. HCV la, lb, 2a, 3a, 3b, 6a, 6e and 6n were found, and the corresponding proportions were 0.66% (3/455), 58.68% (267/455), 17.80% (81/455) and 5.05% (23/455), 3.52% (16/455), 12.31% (56/455), 0.88% (4/455) and 0.66% (3/455). Samples from Guangxi showed the most abundant genetic diversity with 8 subtypes were found. The number of haplotypes in HCV-1b is higher than 2a and 6a. The negative Tajima's D and Fu's Fs values of HCV-1b, 2a and 6a suggested the population expansion of those HCV subtypes. The distribution of HCV GT showed significant statistical difference by age and ethnicity. Conclusion: An abundance of HCV genetic diversity was found in Chinese blood donors with mainly 1b and then 2a subtype. There were significant geographical and demographic differences in HCV GTs/subtypes among Chinese blood donors. HCV subtype 1b has stronger viability and HCV subtype 6a has experienced significant expansion.