Blood safety and availability: continuing challenges in China's blood banking system.

Social and economic development, along with increased health care coverage, has caused a sharp increase in the clinical demand for blood in China. Whole blood collection has increased rapidly in the past decade but has failed to keep pace with the ever-increasing demand. Overall, the country's blood safety has been improved with 99% of whole blood donations collected from voluntary unpaid donors. However, the unmet clinical demand for blood and the increasing incidence of human immunodeficiency virus and syphilis in the general population pose new challenges to China's blood banking system. To ensure a safe and adequate blood supply, continued efforts are required to recruit and retain a sufficient number of low-risk voluntary blood donors, improve donor prescreening and blood testing process, ease donor restrictions, and strengthen patient blood management.

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.

[Synthesis and photochemical virus inactivation of novel phenothiazines].

Virus inactivation with photochemistry is being suitable for blood or blood products, methylene blue (MB)/light treatment has been used for viral inactivation of cellular blood components. Twelve new phenothiazines derivatives were designed and synthesized, and were used to test viral inactivation and red cell damage preliminary. Results showed that compound YWW-7 has a satisfactory activity, it could be developed as a new viral inactivation agent for blood products.

[Correlation between signal/cutoff ratios of anti-HCV enzyme immunoassay (EIA) and their true positivity in blood donors].

OBJECTIVES: To evaluate the correlation between signal/cutoff (S/CO) ratios of anti-HCV EIA and their true positivity for determining the predictive value of S/CO ratios. METHODS: One hundred and fifty-nine samples of blood from donors positive for anti-HCV at the initial screening were collected from Beijing, Guangzhou, Hangzhou, Kunming and Urumchi. All the samples were retested by Ortho and 6 Chinese domestic anti-HCV EIA kits in duplicate, and detected for HCV RNA (NAT) using Chiron Procleix HIV/HCV system (transcription mediated amplification, TMA). The HCV RNA negative samples were further tested for anti-HCV by Chiron RIBA 3.0. Either NAT or RIBA positive samples were interpreted as the true positive. RESULTS: All 7 anti-HCV EIA kits had a significant correlation between S/CO ratios and true positivity. The S/CO ratio of Ortho > or = 3.8 predicted the true positivity in 96.1% of the samples tested. The S/CO ratios of BGI-GBI, GWK, SABC, KHB, InTec, and Wantai were > or = 7.0, > or = 10.0, > or = 6.0, > or = 10.0, > or = 8.6, > or = 14.0 and predicted 96.1%, 96.1%, 97.3%, 96.0%, 96.1%, 96.0% of the true positivity, respectively. CONCLUSIONS: The S/CO ratios of anti-HCV EIA kits are associated with the true positivity. S/CO ratios of Ortho, BGI-GBI, GWK, SABC, KHB, InTec and Wantai predicting > or = 95% true positivity are > or = 3.8, > or = 7.0, > or = 10.0, > or = 6.0, > or = 1 0.0, > or = 8.6 and > or = 14.0, respectively.

A multi-Chinese blood center study testing serologic-negative donor samples for hepatitis C virus and human immunodeficiency virus with nucleic acid testing.

BACKGROUND: A multi-blood center study was conducted to evaluate a human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) multiplex nucleic acid testing (NAT) donor screening test and to determine the residual risk for HIV-1 and HCV infection. STUDY DESIGN AND METHODS: A commercially available HIV-1 and HCV assay (Procleix, Chiron Corp.) was used for simultaneous detection of HIV-1 RNA and HCV RNA on 89,647 unlinked donor samples. NAT was performed with pools of 16 samples that had passed all routine screening tests. Single-donor NAT was performed for samples that had been disqualified by any reactive screening test result(s). Anti-HCV (Ortho third-generation HCV enzyme immunoassay [EIA]), alanine aminotransferase, and HCV NAT (Roche COBAS Amplicor HCV test) confirmatory tests were used for HCV EIA-nonreactive, HCV NAT-reactive samples. RESULTS: Three HCV NAT yield cases and no HIV-1 yield cases were detected. The yield rate for HCV NAT was 3.4 per 10(5) (95 percent confidence interval [CI], 0.7-9.8). The estimated incidence rate for HCV is 24.2 per 100,000 person-years (95% CI, 3.4-88.0). If minipool NAT is added to routine donor screening, the residual risk for HCV is estimated to be reduced to 1 in 20.4x10(4) (95% CI, 1 in 5.2x10(4)-1 in 165.5x10(4)). CONCLUSION: The residual risk for transfusion-transmitted HCV infection is still relatively high in China. Incorporating NAT technology into blood donor screening would be estimated to reduce the residual risk of HCV infections eightfold over current EIA screening.

Significance of the signal-to-cutoff ratios of anti-hepatitis C virus enzyme immunoassays in screening of Chinese blood donors.

BACKGROUND: The correlation between signal-to-cutoff (S/CO) ratios of a second-generation hepatitis C virus (HCV) enzyme immunoassay (EIA; Abbott) and a third-generation HCV enzyme-linked immunosorbent assay (ELISA; Ortho) and confirmed HCV infection has been reported. The utility of the values for the Chinese anti-HCV EIA kits, however, has not been studied in evaluating test results in Chinese blood donors. STUDY DESIGN AND METHODS: A total of 156 donor samples repeat reactive for anti-HCV at routine screening from five representative regions of China were retested for anti-HCV by the Ortho third-generation HCV ELISA and six Chinese EIA kits and for HCV RNA by a human immunodeficiency virus-1 and HCV assay (Procleix, Chiron Corp.). The HCV RNA-nonreactive samples were further tested for anti-HCV by a third-generation recombinant immunoblot assay RIBA (Chiron Corp.). The positive result by either nucleic acid amplification test or RIBA was interpreted as confirmed HCV infection. RESULTS: The confirmed HCV prevalence rate in donors in five representative regions obtained in this study was 0.20 percent (77/37,900) in 2004. All seven anti-HCV EIA kits had a significant correlation between S/CO ratios and confirmed HCV infection. The threshold S/CO ratios, which predicted more than 95 percent of confirmed HCV infections for the Ortho, SABC, BGI-GBI, InTec, GWK, KHB, and WANTAI kits, were 3.8, 6.0, 7.0, 8.6, 10.0, 10.0, and 14.0, respectively. CONCLUSIONS: Anti-HCV EIA kits commonly used in Chinese donors screening demonstrate good correlation between S/CO ratios and the confirmed infection. For the Ortho third-generation HCV ELISA, the S/CO ratio of 3.8 determined by the US Centers for Disease Control and Prevention is applicable to Chinese blood donors. The Chinese domestic EIA kits evaluated show a diverse range of threshold S/CO ratios.

Blood banking in China.

While transfusion-transmissible diseases, including AIDS and viral hepatitis, continue to spread especially in developing countries, the issue of safeguarding the world's blood supply is of paramount importance. China houses more than 20% of the earth's population, and thus its blood supply has the potential to affect the global community. In recent years, Chinese blood centres have tried to improve the nation's blood safety. Although substantial progress has already been made, many daunting difficulties remain. Traditional cultural barriers need to be overcome to successfully mobilise volunteer blood donors. Gaps in information and technology still need to be closed. Insufficiency of economic resources also restrict the blood bank industry. Other developing countries face many of the same challenges as China.