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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. [ABSTRACT FROM AUTHOR]

Background: In China, there is a rising concern on the increasing trends of HIV infections in high-risk groups, who make blood donations that might potentially challenge the blood safety. Analyses on current risk factors for HIV infection among Chinese blood donors are urgently needed for developing effective strategies to defer high-risk donors and to warrant the safety of the blood supply.Study Design and Methods: We recruited 313 HIV-positive and 762 HIV-negative donors from seven study sites in China and evaluated donor demographic characteristics, current medical and behavioral risk factors associated with HIV infection in a case-control survey. Univariable analyses examined the relationship between HIV infection and donor and donation characteristics, medical and behavioral risks, living conditions, and lifestyles. Multivariable logistic regression analyses evaluated the association between selected individual risks and HIV infection. Regression tree analysis was used to select covariates correlated with both HIV infection and individual risks and thus need to be controlled for in logistic regression models.Results: Being a man who has sex with men was associated with the highest odds of HIV infection. Not using a condom, having sex with HIV-infected individuals, having sex partners with sexually transmitted diseases (STDs), having more than two concurrent sex partners, or having an STD were all associated with more than five times higher odds of having HIV. Having remunerated sex was associated with a 2.4 increased odds of having HIV infection.Conclusion: High-risk sexual behaviors were among the major risks for HIV infection among Chinese blood donors. [ABSTRACT FROM AUTHOR]

Background: Previous data, although scant, indicated that the incidence of HIV in China has increased over the past decade. There is a growing concern about the impact of the HIV epidemic on blood safety.Methods and Materials: We used donation data from five geographically-disperse blood centers in 2013-2016 participating in the Recipient Epidemiology and Donor Evaluation Study-III (REDS-III) China program to estimate HIV prevalence and incidence among blood donors. Multivariable logistic regression model was used to examine factors associated with HIV infection in Chinese blood donors.Results: The overall HIV prevalence among first-time donors from 2013 through 2016 was 68.04 per 100,000 donors (95% CI 61.68-74.40). The HIV incidence rate was estimated to be 37.93 per 100,000 person-years (95% CI 30.62-46.97) among first-time donors and 20.55 per 100,000 person-years (95% CI 16.95-24.91) among repeat donors. There was substantial variation in HIV prevalence and incidence rates across blood centers. Multivariable logistic regression results showed that among first-time donors, being male, older than 25 years, minority ethnicity, less than college education, and certain occupations (commercial services, factory workers, retired, unemployed, or self-employed) were associated with positive HIV confirmatory testing results.Conclusion: HIV prevalence and incidence among blood donors remain low in the selected five regions in China; however, an increasing trend is observed at some blood centers. It is important to monitor HIV epidemiology in Chinese blood donors on a continuous basis, especially among populations and regions of higher risk. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The number of red blood cell units transfused per capita in China is lower than in western countries and the reason(s) for the difference is unknown.Study Design and Methods: We randomly chose 5050 transfused patients from five Chinese hospitals. We compared transfused cases to nontransfused controls matched for the same underlying diagnosis. We assessed the pretransfusion hemoglobin (Hb) trigger and other clinical characteristics associated with transfusion. After stratifying by underlying disease, we compared pretransfusion Hb level in Chinese hospitals to 12 US hospitals.Results: In 5050 patients who received transfusion, the pretransfusion Hb levels were lower in medical (6.3 g/dL) compared to surgical patients receiving transfusion postoperatively (8.1 g/dL). In patients with nonsurgical diagnoses, the pretransfusion Hb was much lower than that in the United States; the difference in mean Hb level varied by underlying diagnosis from 0.4 to 1.8 g/dL. In case-control analysis of cases (n = 1356) compared to controls (n = 1201), the pretransfusion Hb showed the strongest association with transfusion. Compared to 10 g/dL, the odds ratio (95% confidence interval) for pretransfusion Hb of 7 to 7.9 g/dL was 37.7 (24.8-57.4).Conclusion: Transfusion triggers in five Chinese hospitals appear comparable to those in the United States for surgical patients; however, medical patients have lower pretransfusion Hb levels (approx. 6 g/dL). Of the factors assessed, the pretransfusion Hb was most strongly associated with transfusion. The clinical impact of lower transfusion thresholds used in China is unknown. [ABSTRACT FROM AUTHOR]

Background: Chinese blood centers use Hepatitis B surface antigen (HBsAg) rapid test (RT) in pre-donation and two rounds of screening with different enzyme-linked immunosorbent assays in post-donation. Nucleic acid testing (NAT) on screening non-reactive (SC-) donations has been gradually implemented since 2010. Yet RT+ and SC-/NAT+ donors are seldom included in hepatitis B virus (HBV) positive rate estimates in Chinese blood donors.Methods: We performed HBsAg neutralization test (NT) on whole blood (WB) with pre-donation RT+ results and post-donation screening reactive (SC+) samples from Mianyang and Chongqing in 2015. The annual totals of pre- and post-donation NT+ donors were combined with the annual totals of SC-/NAT+ donors to derive the estimated HBV positive rates.Result: In Mianyang and Chongqing, 59.4% and 68.2% of RT+ donors in Jan-Aug 2015 contributed for NT, 95.5% and 97.2% of which were NT+ respectively. In 2015, 422 and 667 donors from Mianyang and Chongqing respectively were HBsAg RT+, yielding estimated 403 and 648 pre-donation RT+/NT+ deferrals. 411 and 668 post-donation SC+ samples were NT tested from Mianyang and Chongqing, of which 249 and 323 were NT+ respectively. An estimated 63 donors in Mianyang and 88 donors in Chongqing were SC-/NAT+. The estimated HBV confirmed positive rate in blood donors are 1.59% in Mianyang and 1.01% in Chongqing.Conclusion: Pre-donation HBsAg RT effectively intercepts donations from HBV infected donors. Using NT confirmatory results from RT+, SC+ and SC-/NAT+ donors, this study provides a model for more accurate estimation for HBV positive rates in China. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background: The real infection status of hepatitis B virus (HBV) of hepatitis B surface antigen (HBsAg)-negative yet nucleic acid test (NAT)-positive blood donors is difficult to clarify. Detailed follow-up study is needed for analyzing the infectivity of these blood donors.Study Design and Methods: Blood donors who screened negative for HBsAg and reactive for simultaneous NAT of HBV, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) were included in a follow-up epidemiologic questionnaire survey and contributed follow-up samples for further testing. The follow-up samples were tested repeatedly for the serologic markers and HBV DNA. The genotypes and sequence mutations of HBV infected by 11 HBV DNA-positive donors were analyzed through the amplification and sequencing of HBV S region.Results: Of the 46 donors included in this study, 89.1% were infected with HBV (41/46), including one (2.2%) window period infection, three (6.5%) recovered infections, and 37 (80.4%) occult HBV infections (OBIs). The S region of HBV was successfully amplified and sequenced for seven donors, five infected with Genotype B (71.4%), one with Genotype C (14.3%), and one with Genotype D (14.3%). Mutations in the S region were detected in four donors (57.1%) CONCLUSIONS: This is the first detailed study with multiple follow-up testing of the HBV infection status among blood donors who were tested negative for HBsAg and reactive for simultaneous NAT of HBV, HCV, and HIV. Most of these donors were infected with HBV with very low viral load. Our findings indicate that it is important to improve the sensitivity of NAT so as to decrease the residual risk of transfusion-transmitted HBV infection. [ABSTRACT FROM AUTHOR]

Background The risk of hepatitis E virus ( HEV) infection from blood transfusion has aroused increasing concern in many countries. The aim of this study was to analyze the potential risk of HEV infection through blood transfusion in China. Study Design and Methods Qualified blood donations and donations with isolated alanine aminotransferase ( ALT) elevations from five geographically diverse Chinese regions were tested for anti- HEV immunoglobulin ( Ig) M and IgG and HEV antigen. The positive samples for anti- HEV IgM and HEV antigen were tested for HEV RNA. HEV open reading frame ( ORF)2 partial sequences were analyzed from HEV RNA-positive samples. Results The seroprevalence rates of HEV antigen and anti- HEV IgM and IgG among qualified donations were 0.06% (6/10,741), 1.02% (109/10,741), and 27.42% (2945/10,741), respectively. Samples with isolated ALT elevations had higher prevalence of HEV markers, namely, HEV antigen of 0.25% (2/797), anti- HEV IgM of 2.76% (22/797), and anti- HEV IgG of 40.02% (319/797). The HEV antibody prevalence varied significantly by age, sex, and geographic region. All 131 samples that were anti- HEV IgM positive were negative for HEV RNA, whereas four of eight (50%) samples positive for HEV antigen were HEV RNA positive. HEV ORF2 sequences from three of four HEV RNA-positive samples were determined and grouped with Genotype 4. Conclusion Qualified donations after routine blood donor screening still carry potential risk for transmitting HEV. HEV antigen screening could be one measure to reduce the risk of HEV transmission by blood transfusion. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Background Single-nucleotide polymorphisms ( SNPs) near the interleukin ( IL)28 B gene have been shown to be associated with spontaneous clearance of hepatitis C virus ( HCV) infection in western populations. Anti- HCV-reactive and HCV RNA-negative samples were often found in Chinese blood donors. This study was to determine whether the IL28 B gene variant is also associated with the natural outcome of HCV infection in Chinese blood donors. Study Design and Methods A total of 111 anti- HCV-negative blood donors and 100 anti- HCV-reactive subjects were enrolled in this study. HCV-infected blood donors were classified into spontaneous clearance group and chronic infection group through HCV RNA detection. IL28 B genetic variations (rs8099917 and rs12979860) were genotyped by polymerase chain reaction and direct sequencing. Results A total of 24 (24.0%) donors spontaneously cleared HCV. The rs12979860 C allele frequency was 90.3% and the rs8099917 T allele frequency was 96.7% in our study. The rs12979860 CC genotype was strongly associated with spontaneous HCV clearance. Female blood donors had a higher rate of spontaneous HCV clearance than male donors (15/42 [35.7%] vs. 9/58 [15.5%], p = 0.02). Conclusions The rs12979860 CC variant upstream of IL28 B gene is associated with spontaneous clearance of HCV in Chinese blood donors and female donors are more likely to clear HCV infection than male donors. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

BACKGROUND: In China, the growing syphilis epidemic parallels the spread of human immunodeficiency virus (HIV) in the general population. This study evaluated the prevalence and incidence of serologic markers for syphilis among donors at five Chinese blood centers. STUDY DESIGN AND METHODS: We examined whole blood and apheresis donations collected from January 2008 through December 2010. Postdonation testing of syphilis was conducted using two different Treponema pallidum antibody enzyme-linked immunosorbent assay kits. The prevalence of serologic markers for syphilis (%), and the rate of coinfection with HIV-1/2, hepatitis B virus (HBV), and hepatitis C virus (HCV) were calculated. A multivariable logistic regression analysis was conducted examining donor characteristics associated with positive syphilis serology. Seroconversion rate and syphilis incidence were estimated. RESULTS: Of 801,511 donations, 60% were from first-time donors and 40% were from repeat donors. There was a significant increase in syphilis serologic markers among first-time donors with 0.41, 0.45, and 0.57% positivity over 3 years (p < 0.001). Approximately 2.8, 0.8, and 0.5% of HIV-1/2-, HBV-, and HCV-positive donations also tested reactive for syphilis. Logistic regression results suggest that first-time donors were nine times more likely to be syphilis positive than repeat donors. Higher syphilis positivity was associated with donors older than 25 years and with less education. Estimated incidence among repeat donations was 33 (95% confidence interval, 29-39) per 100,000 person-years. CONCLUSION: The increase in syphilis serologic prevalence reflected the syphilis epidemic in the general population. Without screening, most of these syphilis-positive donations would get into the blood supply. Thus, during a syphilis epidemic, continued syphilis screening of blood donations may be important to maintain blood safety and public health. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Objective : To get full knowledge of current conditions and development in the past seven years of clinical transfusion practice in Sichuan, China. Study Design and Methods : This survey was performed by means of a questionnaire which consisted of three parts of questions including basic conditions of blood banks in the hospitals, procedures for clinical blood transfusion and the utilization of different types of blood products. Thirty-five representative hospitals from different geographic locations in Sichuan province participated in this survey. Results : All of the 35 hospitals returned the questionnaires and 33 hospitals (94.3%) answered the questions completely. The blood bank information system began to be used by more hospitals from 2006 (21.21%, 7/33) to 2012 (48.48%, 16/33). Automated grouping and cross-matching systems have not been used in level 2 hospitals and only 3 level 3 hospitals used automated systems in 2012. Still less common were procedures for evaluation of blood order forms for appropriateness (2/33, 6.06%) and evaluation of appropriateness and effect of blood component transfusion (8/33, 24.2%), and all the hospitals having these procedures are level 3 hospitals. The percentage of whole blood usage in the volume of all types of blood products used decreased a lot from 7.45% in 2006 to 0.16% in 2010. Technological instruments for bedside checking are not used by any of the hospitals. Conclusions : The transfusion service degree of the hospitals in Sichuan, China, has developed a lot in the past seven years; however, there are still some problems including whole blood still being used, albeit decreasing; lack of independent blood banks within the hospitals; lack of dedicated personnel for the transfusion services; lack of education; lack of blood bank information systems and automation; lack of screening for appropriateness for blood orders. Thus, the quality control center of clinical blood transfusion (QCCCBT) of Sichuan province should help the transfusion departments to attract more investment in staffing, equipment and information system from the hospitals, enhance the training of transfusion department staffs, and emphasize the supervision of transfusion department's work on directing clinical blood utilization and evaluating clinical transfusion appropriateness. [ABSTRACT FROM AUTHOR]

Human immunodeficiency virus-1 (HIV-1) exhibits high diversity and complexity in China, challenging the disease surveillance and antiretroviral therapy. Between July 1, 2014 and January 30, 2017, we investigated the profiles of HIV-1 infection stages, genotype distribution and drug resistance mutations (DRMs) using plasma samples from HIV Western blot (WB) confirmed blood donors from five Chinese blood centers (Chongqing, Guangxi, Luoyang, Mianyang, and Urumqi). HIV pol regions consisted of whole protease and partial reverse transcriptase were genotyped and analyzed for DRMs. Lag-Avidity testing was performed to identify the infection stages. Of the 356 HIV-1 WB positive samples tested by Lag-avidity assay, 19.1% (68/356) were recent infections. Genotyping on 356 amplified sequences presented the subtype distributions as following: CRF07&#95;BC (65.7%), CRF08&#95;BC (7.3%), CRF01&#95;AE (19.1%), B (4.2%), CRF55&#95;01B (3.1%), CRF59&#95;01B (0.3%) and CRF68&#95;01B (0.3%). No significant difference in genotype distribution was observed between recent and long-term infections. 48 DRMs were identified from 43 samples, indicating a drug resistance prevalence of 12.1% (43/356), which include seven protease inhibitors (PIs) accessory DRMs (Q58E, L23I and I84M), two PIs major DRMs (M46I, M46L), seven nucleoside RT inhibitors DRMs (D67N, K70Q, K219R and M184L), and 32 non-nucleoside RT inhibitors DRMs (K103N, V179E, K238N, V179D, E138G, G190E, A98G, Y188D and E138A). In addition, we had also identified CRFs from the 01B subtype including CRF55&#95;01B (3.1%), CRF59&#95;01B (0.3%) and CRF68&#95;01B (0.3%). As an important part of the continuous monitoring of HIV-1 circulating strains among blood donors, our findings were expected to contribute to the comprehensive AIDS control and development of proper diagnostics for HIV-1 in China., Competing Interests: The authors have declared that no competing interests exist.

Background: Severe fever with thrombocytopenia syndrome bunyavirus (sftsv) is an emerging tick-borne rna virus recently identified as the pathogen that causes severe fever with thrombocytopenia syndrome (sfts) in china. the existing commercial nucleic acid testing (comnat) assay with a relatively high claimed limit of quantitative detection (loqd) is not capable of sensitive detection and quantitation of sftsv. Thus, a new real-time reverse transcriptase (rt)-pcr assay with improved sensitivity is needed for clinical diagnosis; it could also be used to screen blood donors if necessary., Materials and Methods: We developed a new sftsv rt-pcr nat assay (newnat). About 129 plasma samples from 93 suspected sfts patients with typical clinical symptoms were tested using an anti-sftsv total antibody elisa and both comnat and newnat. The test performance of the two nat assays was evaluated and compared., Results: The newnat had a lower limit for quantitative testing compared to comnat. Twelve samples were comnat negative but newnat positive. Out of 35 suspected sfts patients who were comnat negative and anti-sftsv total antibody negative, four tested positive by the newnat assay and one of these four seroconverted within 2-4 days after testing newnat positive. A high correlation was observed between the cts of the newnat and comnat assays., Conclusion: The newnat assay was sensitive for quantitative detection of sftsv and may be applicable to clinical diagnosis and studies of the need for blood donor screening., (© 2017 Wiley Periodicals, Inc.)

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&#95;BC (61.5%), CRF08&#95;BC (8.3%), CRF01&#95;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.

Background: Severe fever with thrombocytopenia syndrome virus (SFTSV), an emerging tick-borne pathogen that can cause fatal severe fever with thrombocytopenia syndrome, was first identified in China in 2009. Limited evidence suggests that SFTSV can be transmitted between humans via blood contact, raising concerns over transfusion safety. A study of donor samples from three Chinese blood centers was conducted to investigate the seroprevalence and rate of SFTSV viremia among Chinese blood donors., Study Design and Methods: From April 16 to October 31, 2012, a total of 17,208 plasma samples were collected from donors at Xinyang (located in an SFTSV-endemic area), Mianyang, and Luoyang Blood Centers. Assessment of anti-SFTSV total antibody was performed on all samples using enzyme-linked immunosorbent assay. Repeat-reactive samples were tested for SFTSV RNA using reverse transcription (RT)-real-time polymerase chain reaction (PCR) assay with Taqman probes. In addition, 9960 of the Xinyang samples were tested in pools of 4 by the same PCR method and each of the samples in a reactive pool was tested individually., Results: Donor seroreactivity rates were as follows: Xinyang, 0.54% (80/14,752); Mianyang, 0.27% (3/1130); and Luoyang, 0.28% (3/1326). All seroreactive samples were negative on RT-PCR single-sample testing. Two RT-PCR-reactive donor samples were identified, both with estimated viral load of less than 20 plaque-forming units/mL. The RNA prevalence rate for SFTSV among donors in Xinyang was 0.02%., Conclusion: This was the first multiregion study of SFTSV sero- and viral prevalence among Chinese blood donors. Viral prevalence was low and no seroreactive sample was viremic, suggesting a limited impact of SFTSV on blood safety in China., (© 2014 AABB.)

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., (© 2014 AABB.)

Unlabelled: We investigated the migration patterns of hepatitis C virus (HCV) in China. Partial E1 and/or NS5B sequences from 411 volunteer blood donors sampled in 17 provinces and municipalities located in five large regions, the north-northeast, northwest, southwest, central south, and southeast, were characterized. The sequences were classified into eight subtypes (1a, n = 3; 1b, n = 183; 2a, n = 83; 3a, n = 30; 3b, n = 44; 6a, n = 55; 6n, n = 10; 6v, n = 1) and a new subtype candidate. Bayesian evolutionary analysis by sampling trees of the E1 sequences of the five major subtypes revealed distinct migration patterns. Subtype 1b showed four groups: one is prevalent nationwide with possible origins in the north-northeast; two are locally epidemic in the central south and northwest, respectively, and have spread sporadically to other regions; and the fourth one is likely linked to the long-distance dispersion among intravenous drug users from the northwest. Subtype 2a showed two groups: the larger one was mainly restricted to the northwest and seemed to show a trend toward migration via the Silk Road; the smaller one was geographically mixed and may represent descendants of those that spread widely during the contaminated plasma campaign in the 1990s. Subtype 3a exhibited three well-separated geographic groups that may be epidemically unrelated: one showed origins in the northwest, one showed origins in the southwest, and the other showed origins in the central south. In contrast, subtype 3b had a mixture of geographic origins, suggesting migrations from the southwest to the northwest and sporadically to other regions. Structurally resembling the tree for subtype 3a, the tree for subtype 6a showed four groups that may indicate migrations from the central south to southeast, southwest, and northwest. Strikingly, no subtype 6a strain was identified in the north-northeast., Importance: With a population of greater than 1.3 billion and a territory of >9.6 million square kilometers, China has a total of 34 provinces and municipalities. In such a vast country, the epidemic history and migration trends of HCV are thought to be unique and complex but variable among regions and are unlikely to be represented by those observed in only one or at best a few provinces and municipalities. However, due to the difficulties in recruiting patients, all previous studies for this purpose have been based only on data from limited regions, and therefore, geographical biases were unavoidable. In this study, such biases were greatly reduced because we utilized samples collected from volunteer blood donors in 17 provinces and municipalities. To our knowledge, this is the first study in which the HCV isolates represented such a large portion of the country, and thus, the results should shed light on the current understanding of HCV molecular epidemiology., (Copyright © 2014, American Society for Microbiology. All Rights Reserved.)

Background: Co-infections of HBV and HIV are frequent due to similar routes of transmission. In that transmission through blood is an important route for both HBV and HIV, evaluation of the prevalence of HBV in HIV infected blood donors may be important for transfusion safety. In addition, because the epidemiological characteristics of HBV in HIV infected patients and blood donors may differ from each other, understanding of it could be significant for therapy and prevention of HBV in HIV infected adults. However, data reported on these in Chinese people remains limited., Methods: 614 HIV confirmed positive samples were collected from blood donors and patients and were screened for HBsAg and HBV DNA. The samples screened reactive for HBsAg or positive for HBV DNA were tested for the other serological markers of HBV including anti-HBs, HBeAg, anti-HBe and anti-HBc. For the samples tested positive for HBV DNA, the S region of HBV was amplified by nested PCR and the HBV genotypes were determined., Results: HBV coinfections were found in 12.9% (79/614) HIV infected individuals including 42/417(10.1%) blood donors and 37/197 (18.8%) AIDS patients. In the HBsAg positive individuals, 80.0% were HBeAg negative in which 10.0% were HBV DNA negative and 38.3% with HBV DNA lower than 2000 IU/ml. The average HBV DNA levels were lower in donors than in patients. In the HBV DNA positive populations, HBV genotypes B, A and C accounted for 48.1%, 22.8% and 8.86% respectively. Mutations related to the failure of HBsAg detection were found in 2 of the 4 HBsAg-/HBV DNA + subjects., Conclusions: High prevalence of HBV in HIV infected individuals was found in this study. Hence, we recommend routine testing of HBV for patients newly diagnosed with HIV/AIDS in China. Some HIV-HBV co-infected patients remain undiagnosed if only conventional serological markers for HBV are used and it's important to detect HBV DNA for HIV infected patients. HBV DNA levels were relatively low in HBeAg negative patients, thus this serologic marker may be useful in prioritizing patients on their need for HBV treatment in settings in which HBV DNA is not available.

AIDS is becoming one of leading cause of death among infectious diseases in China. There has been rapidly increasing epidemic of HIV/AIDS in Chengdu since 2003. In order to investigate HIV-1 subtype distribution, drug resistance-associated mutations as well as drug resistance prevalence among treatment naïve HIV-infected individuals in Chengdu of China, 244 HIV confirmed-reactive serum samples were collected from 2007 to 2010, including 165 obtained from blood centers and 79 obtained from hospitals. HIV-1 pol including whole protease, and partial reverse transcriptase genes was amplified, sequenced, and analyzed for subtype determination and drug resistance profile description. A total of 159 amplified sequences which were acquired from 98 sample obtained at blood centers and 61 samples obtained at hospitals had the following genotype distribution: G (0.6%), F1 (0.6%), A1 (0.6%), B (1.9%), circulating recombinant form (CRF) 01&#95;AE (42.8%), CRF07&#95;BC (49.1%), and CRF08&#95;BC (4.4%). There were 12.2 and 24.6 % samples obtained from blood centers and hospitals, respectively, that harbored drug resistance-associated mutations, and the prevalence of drug resistance among all cases was 1.3%. This was the first report of HIV molecular surveillance among treatment naïve HIV-infected individuals in Chengdu. Our findings were believed to be helpful on contribution to comprehensive HIV control program in China.

Background: Single-nucleotide polymorphisms (SNPs) near the interleukin (IL)28B gene have been shown to be associated with spontaneous clearance of hepatitis C virus (HCV) infection in western populations. Anti-HCV-reactive and HCV RNA-negative samples were often found in Chinese blood donors. This study was to determine whether the IL28B gene variant is also associated with the natural outcome of HCV infection in Chinese blood donors., Study Design and Methods: A total of 111 anti-HCV-negative blood donors and 100 anti-HCV-reactive subjects were enrolled in this study. HCV-infected blood donors were classified into spontaneous clearance group and chronic infection group through HCV RNA detection. IL28B genetic variations (rs8099917 and rs12979860) were genotyped by polymerase chain reaction and direct sequencing., Results: A total of 24 (24.0%) donors spontaneously cleared HCV. The rs12979860 C allele frequency was 90.3% and the rs8099917 T allele frequency was 96.7% in our study. The rs12979860 CC genotype was strongly associated with spontaneous HCV clearance. Female blood donors had a higher rate of spontaneous HCV clearance than male donors (15/42 [35.7%] vs. 9/58 [15.5%], p = 0.02)., Conclusions: The rs12979860 CC variant upstream of IL28B gene is associated with spontaneous clearance of HCV in Chinese blood donors and female donors are more likely to clear HCV infection than male donors., (© 2013 American Association of Blood Banks.)

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., (© 2013 American Association of Blood Banks.)

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., (© 2012 American Association of Blood Banks.)

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&#95;AE (32.7%), CRF07&#95;BC (22.1%), and CRF08&#95;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., (© 2011 American Association of Blood Banks.)

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., (© 2011 American Association of Blood Banks.)

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., (© 2010 American Association of Blood Banks.)

Background: In China recruitment and retention of sufficient numbers of safe blood donors continues to be a challenge. Understanding who donates blood, particularly those who donate larger (>200 mL) whole blood (WB) units, will help blood centers to target more effective recruitment and retention strategies., Study Design and Methods: Demographic characteristics of 226,489 allogeneic WB donors from January to December 2008 at five geographically and ethnically diverse, urban blood centers were analyzed., Results: The typical Chinese WB donor can be characterized as first-time volunteer (67.9%), male (56.9%), less than 45 years old (93.8%), and Han ethnicity (86.1%). Most donors had some college or below educational level (77.5%), donated at a mobile collection site (97.6%), and donated 300- or 400-mL units (76.0%). Differences in WB volume donations and donor demographics exist among the five centers., Conclusion: In China compared to the United States, donations are made by younger donors and donors give infrequently and make smaller WB donations. To help ensure supply adequacy, continued efforts are needed to have donors give larger volumes of WB in China., (© 2010 American Association of Blood Banks.)

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., (© 2010 American Association of Blood Banks.)