The persistence of hepatitis C virus transmission risk in China despite serologic screening of blood donations.

BACKGROUND: A total of 2%-2.9% of the population in China is infected with hepatitis C virus (HCV). This study estimated the prevalence and incidence of HCV among Chinese blood donors. STUDY DESIGN AND METHODS: We examined whole blood and apheresis platelet donations at five Chinese blood centers in 2008 to 2010. All donations were screened using two rounds of testing for alanine aminotransferase, antibody to human immunodeficiency virus Types 1 and 2, hepatitis B surface antigen, anti-HCV, and syphilis. Screening reactivity is defined by a reactive result in one or both rounds of screening tests. Confirmatory tests (Ortho third-generation HCV enzyme immunoassay, Johnson & Johnson) were performed on anti-HCV screening-reactive samples. Confirmatory positive rates among first-time donors (prevalence) and repeat donors (incidence) were calculated by blood center and demographic categories. Donor characteristics associated with HCV confirmatory status among first-time donors were examined using trend test and multivariable logistic regression analysis. RESULTS: Among 821,314 donations, 40% came from repeat donors. The overall anti-HCV screening-reactive rate was 0.48%. Estimated HCV prevalence was 235 per 100,000 first-time donors; incidence was 10 per 100,000 person-years in repeat donors. In multivariable logistic regression analysis, first-time donors older than 25 years displayed higher HCV prevalence than the younger donors. Less education is associated with higher HCV prevalence. Donors 26 to 35 years old and those above 45 years displayed the highest incidence rate. CONCLUSION: High prevalence and incidence in donors indicate high residual risks for transfusion-transmitted HCV in Chinese patients. Implementation of minipool nucleic acid testing in routine donation screening may prevent a substantial number of transfusion-transmitted 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.

An analysis of risk factors for human immunodeficiency virus infection among Chinese blood donors.

BACKGROUND: Information regarding the risk factors for human immunodeficiency virus (HIV) infection among Chinese donors is important for understanding the trend of HIV transmission routes and for developing effective donor behavioral screening policies. STUDY DESIGN AND METHODS: In 2009 to 2011, a total of 77 HIV-positive and 649 HIV-negative consented donors who screened nonreactive for hepatitis B virus, hepatitis C virus, syphilis, and alanine aminotransferase in four Retrovirus Epidemiology Donor Study-II Chinese regions received and completed a questionnaire by mail regarding their recent and past medical procedures, drug use, and sexual behaviors, etc. Exploratory and confirmatory factor analyses grouped questions into three risk factors. Multivariable logistic regression analysis examined the relationship between risk factors and HIV status adjusting for center, age, sex, and education. RESULTS: The three risk factors were test-seeking tendency, medical-related risks, and behavioral risks. In multivariable logistic regression analysis, greater test-seeking tendency and behavioral risks were associated with HIV infection, with the adjusted odds ratios (ORs) being 2.2 (95% confidence interval [CI], 1.2-4.1) and 3.8 (95% CI, 1.8-7.9), respectively, but medical risks were not (OR, 1.2; 95% CI, 0.6-2.2). In comparison to less high school education, high school and more education was associated with lower risks for HIV infection, with the ORs being 0.35 (95% CI, 0.17-0.70) and 0.17 (95% CI, 0.09-0.33), respectively. CONCLUSIONS: Test-seeking tendency and high-risk sexual behaviors are important predictors of HIV infection in Chinese blood donors, suggesting that the health history inquiry used in donor selection process needs improvement to defer high-risk donors more effectively.

Prevalence, incidence, and residual risks for transfusion-transmitted human immunodeficiency virus Types 1 and 2 infection among Chinese blood donors.

BACKGROUND: There are little data on human immunodeficiency virus (HIV) prevalence, incidence, or residual risks for transfusion-transmitted HIV infection among Chinese blood donors. STUDY DESIGN AND METHODS: Donations from five Chinese blood centers in 2008 to 2010 were screened using two rounds of enzyme-linked immunosorbent assay for anti-HIV-1/2. A reactive result in either or both rounds led to Western blot confirmatory testing. HIV prevalence among first-time donors and incidence among repeat donors were examined. Weighted multivariable logistic regression analysis examined correlates of HIV confirmatory status among first-time donors. Residual risks were evaluated based on incidence among repeat donors. RESULTS: Among 821,320 donations, 40% came from repeat donors. A total of 1837 (0.34%) first-time and 577 (0.17%) repeat donations screened reactive, among which 1310 and 419 were tested by Western blot. A total of 233 (17.7%) first-time and 44 (10.5%) repeat donations were confirmed positive. Prevalence was 66 infections per 100,000 (95% confidence interval [CI], 59-74) first-time donors. Incidence was 9 of 100,000 (95% CI, 7-12) person-years among repeat donors. Multivariable logistic regression analysis indicates that first-time donors 26 to 45 years old were 1.6 to 1.8 times likely to be HIV positive than those 25 years and younger. Donors with some college or above education were less likely to be HIV positive than those with middle school education, odds ratios (ORs) ranging from 0.35 to 0.60. Minorities were 1.5 times likely to be HIV positive than Han majority donors (OR, 1.6; 95% CI, 1.2-2.1). HIV residual risk was 5.4 (95% CI, 1.2-12.5) infections per million whole blood donations. CONCLUSION: Despite the declining HIV epidemic in China, estimated residual risks for transfusion-transmitted HIV infection are still high.

Molecular epidemiological study of hepatitis B virus in blood donors from five Chinese blood centers.

Although the genetic variability of hepatitis B virus (HBV) in HBV-infected patients has been extensively studied, reports on genotypes, subtypes and mutations in the S region of HBV strains from Chinese blood donors are limited. In this study, 245 blood samples from HBsAg-positive blood donors were collected from five geographically diverse blood centers in China. The S region of HBV was amplified, and the HBV genotype and subtype were determined. The amino acid sequences of the S region were aligned, and mutations related to the failure of immunization and HBsAg detection were determined. Of the 245 samples, 228 (93 %) were genotyped successfully. We found that genotypes B, C, D and A accounted for 58.8 %, 21.9 %, 6.6 % and 3.95 % of the isolates, respectively. The distribution of HBV antigen subtypes was as follows: adw (67.6 %), adr (23.3 %) and ayw (8.7 %). Mutations were present in 39 (17.1 %) of 228 samples in the major hydrophilic region (MHR) of the S region. This study demonstrated that HBV genotype/subtype B/adw was the most frequent strain circulating in HBV-infected Chinese blood donors, followed by C/adr. The occurrence of MHR mutants in HBV-infected blood donors and the potential failure to detect some of them in collected units poses a threat to transfusion safety.

The human immunodeficiency virus-1 genotype diversity and drug resistance mutations profile of volunteer blood donors from Chinese blood centers.

BACKGROUND: The global human immunodeficiency virus (HIV)-1 epidemic is becoming increasingly diverse and complex. Molecular epidemiologic characteristics were studied for HIV-1-infected blood donors from five Chinese regions to determine genotype diversity and drug resistance mutations (DRMs) profile. STUDY DESIGN AND METHODS: HIV-1 confirmed-reactive serum samples were collected from 172 blood donors from five blood centers during 2007 to 2010. HIV-1 Pol including whole protease and partial reverse transcriptase genes was amplified, sequenced, and analyzed for the subtype determination and drug resistance profile description. RESULT: A total of 113 amplified sequences including 82 from Kunming blood center and 31 from four other blood centers had the following genotype characteristics: G (0.9%), B (2.7%), circulating recombinant form (CRF) 01_AE (32.7%), CRF07_BC (22.1%), and CRF08_BC (41.6%). Female donors represent 45.1% of all cases and 63.9% cases with DRMs. The prevalence of samples with potential low or higher resistance among Chinese blood donors is 4.4%. CONCLUSION: HIV-1 infection in Chinese blood donors is genetically diverse and the subtype distribution reflects that from the high-risk populations. Our results support continuous molecular epidemiologic surveillance for HIV-1 in blood donors as a part of a comprehensive HIV control program.

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.