The infection staging and profile of genotypic distribution and drug resistance mutation among the human immunodeficiency virus-1 infected blood donors from five Chinese blood centers, 2012-2014.

The increasing complexity and diversity of the human immunodeficiency virus-1 (HIV-1) infections challenge the disease control and anti-retrovirus treatment in China. The infection stages and molecular characteristics of HIV-1 from infected Chinese blood donors were examined to shed light on the HIV genotype distribution and the status of drug resistance mutations (DRMs) in the changing HIV epidemic in China. Western blot (WB) confirmed HIV-1 positive plasma samples were collected from blood donors at five Chinese blood centers from April 16, 2012, through June 30, 2014. The HIV infection stages were determined using the Lag-avidity assay. HIV Pol regions including whole protease and partial reverse transcriptase (RT) were amplified and sequenced to establish the profile of genotype distribution and drug resistance mutations (DRMs). Viral loads were determined using the ROCHE COBAS system. Of the 259 HIV-1 positive samples tested by the Lag-avidity assay, 23.6% (61/259) were identified as recent infections. A total of 205 amplified sequences displayed the following genotype distributions: circulating recombinant form (CRF) 07_BC (61.5%), CRF08_BC (8.3%), CRF01_AE (20%), B (6.3%), and 01B (3.9%). There was no significant difference in genotype distribution between recent and long-term infections. 31 DRMs were identified from 27 samples including four protease inhibitors (PIs) accessory DRMs, two PIs major DRMs (M46I), two nucleoside RT inhibitors DRMs (K219R and K70Q), and 23 nonnucleoside RT inhibitors DRMs. 27 samples had DRMs, yielding a drug resistance prevalence of 13.2% (27/205). Our findings provide important information for developing strategies for comprehensive HIV control and improving anti-retroviral treatment in China.

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.

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.

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.

Demographics of apheresis platelet donors in five blood centers in China.

BACKGROUND: Blood component donations by apheresis has become more common in modern blood transfusion practices. However, apheresis donation still remains less common in China. This study describes the demographic profile and transfusion-transmissible infection (TTI) prevalence among donors making apheresis platelet (AP) donations compared to those making whole blood (WB) donations and the differences among five geographically diverse blood centers in China. STUDY DESIGN AND METHODS: This is a descriptive study using data from all successful donations at the five blood centers in 2008 and 2009. Donor demographic and TTI screening reactive rates were collected for WB and AP donations and blood centers. Logistic regression was used to identify independent factors associated with AP donations. RESULTS: From January 1, 2008, to December 31, 2009, there were 512,594 WB and 26,199 AP donations at five blood centers. AP donations accounted for 4.9% of all donations. AP donations have lower reactive rate than WB donations for hepatitis B virus surface antigen, hepatitis C virus antibodies, human immunodeficiency virus antibodies, and syphilis screening testing. Males, donors older than 25 years old, non-Han donors, and donors with below high school educational level were more likely to make AP donations. The characteristics of AP donations differed among the five Chinese blood centers. CONCLUSION: Our analysis suggests that the characteristics of AP donations in China are different from WB donations and differ among the five Chinese blood centers. Some of the differences are likely due to different recruitment policies. Further studies should be conducted to understand what motivates Chinese blood donors to participate as AP donors.

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.

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.

Analysis of Chinese donors' return behavior.

BACKGROUND: It is important to understand donor return behavior. Converting first-time donors to become repeat donors is essential for maintaining an adequate blood supply. STUDY DESIGN AND METHODS: Characteristics of 241,552 whole blood (WB) donations from first-time and repeat donors who donated in 2008 at the five blood centers in China were compared. A subset of 54,394 WB donors who donated between January 1 and March 31, 2008, were analyzed for their return behavior in 2008 after the index donation using logistic regression. RESULTS: Of all donations, 64% were from first-time donors. Donors with self-reported previous donations tended to be male, older, and married; donated larger volume (≥ 300 mL); and were heavier in weight. Among donors who donated from January to March 2008, 14% returned for subsequent WB donations by the end of 2008. The number of previous donations and blood collection location were the two strongest predictors for making subsequent donations. Donors with one, two to three, and more than three previous donations were 3.7, 5.7, and 11.0 times more likely to return than first-time donors. Those who donated in a blood collection vehicle were four times more likely to return than those who donated at a blood center. Being female, younger, and of a lower education level (middle school or less) were positively associated with subsequent return blood donation during the follow-up period observed in this study. CONCLUSION: Most of the Chinese blood supply is from first-time donors. Strategies aimed at encouraging current donors to become repeat donors are needed.

Impact of the May 12, 2008, Earthquake on blood donations across five Chinese blood centers.

BACKGROUND: On May 12, 2008, a severe earthquake struck China's Sichuan Province. The nationwide outpouring of charity resulted in a surge of subsequent blood donations. The quantity and quality of these donations were examined in comparison with routine donations. STUDY DESIGN AND METHODS: Whole blood and apheresis donations from five geographically different blood centers collected within 1 week postearthquake were compared with those collected during the rest of the year. Regional differences, demographic characteristics, first-time and repeat donor status, and infectious disease screening markers associated with these donations were compared by earthquake status using chi-square statistics. Poisson regression analysis examined the number of daily donations by earthquake status after adjusting for center, day of week, and seasonal variations. RESULTS: The number of daily donations across five blood centers increased from 685 on a typical day to 1151 in the postearthquake week. The surge was observed in both sexes and across different education levels, age, and ethnicity groups and three blood centers and was significant after adjusting for confounding covariates. The influx of first-time donors (89.5%) was higher than that of repeat donors (34%). There was a significant change in the overall screening reactive marker rates excluding alanine aminotransferase (2.06% vs. 1.72%% vs. 4.96%). However, when the individual screening test was analyzed separately, no significant differences were found. CONCLUSION: Timely donations in response to a disaster are crucial to ensure emergency blood transfusion. The dramatically increased postearthquake donations suggest that Chinese blood centers are capable of handling emergency blood needs. Measures to maintain blood safety should be taken in times of emergency.