Brief report on the United States Food and Drug Administration Blood Products Advisory Committee recommendations for management of donors and units testing positive for hepatitis B virus DNA

BACKGROUND AND OBJECTIVES: This article briefly recounts the 21st July 2005, Blood Products Advisory Committee (BPAC) meeting concerning recommendations for management of donors and units testing positive for hepatitis B virus (HBV) DNA. MATERIALS AND METHODS: The author attended the meeting. The United States Food and Drug Administration (FDA) web site was used for meeting materials, and handouts were collected at the meeting to provide narrative information. Two European experts assisted with HBV subject matter. RESULTS: The proceedings of the advisory committee, the issue briefing materials, and testing algorithms are presented. CONCLUSION: BPAC voted concurrence with the FDA algorithm for Management of Donors and Units Testing Positive for Hepatitis B Virus DNA.     

猴泡沫病毒(SFV)RT-nestedPCR检测方法的建立及初步应用

目的建立实验猴群及相关生物制品猴泡沫病毒(SFV)的PCR检测方法。方法选择SFV-1、SFV-3、SFVCPZ前病毒序列的pol基因同源性较高的区域设计嵌套引物对SFV-1毒种进行RT-nestedPCR扩增并克隆测序,以确定其准确性,通过验证方法的特异性和敏感性,初步应用该方法对恒河猴外周血淋巴细胞(PBLs),常用猴肾传代细胞及猴源性生物制品进行检测。结果经RT-nestedPCR扩增出的片断与SFV-1 cDNA序列同源性达到99%,对10只恒河猴的检测结果为5只阳性,5只阴性,对常用猴肾传代细胞及脊髓灰质炎疫苗的检测结果均为阴性。结论所建立的SFV RT-nestedPCR检测方法能准确的检测出恒河猴SFV的感染情况,对控制实验猴群的质量具有重要意义。该方法可用于检测猴源性生物制品中SFV的污染情况,为保证生物制品应用的安全性提供一定依据。     

Multifactorial analysis of predictors of outcome in pediatric intracranial ependymoma

Pediatric ependymomas are enigmatic tumors, and their clinical management remains one of the more difficult in pediatric oncology. The identification of biological correlates of outcome and therapeutic targets remains a significant challenge in this disease. We therefore analyzed a panel of potential biological markers to determine optimal prognostic markers. We constructed a tissue microarray from 97 intracranial tumors from 74 patients (WHO grade II-III) and analyzed the candidate markers nucleolin, telomerase catalytic subunit (hTERT; antibody clone 44F12), survivin, Ki-67, and members of the receptor tyrosine kinase I (RTK-I) family by immunohistochemistry. Telomerase activity was determined using the in vitro-based telomere repeat amplification protocol assay, and telomere length was measured using the telomere restriction fragment assay. Primary tumors with low versus high nucleolin protein expression had a 5-year event-free survival of 74%+/-13% and 31%+/-7%, respectively. Multivariate analysis identified low nucleolin expression to be independently associated with a more favorable prognosis (hazard ratio=6.25; 95% confidence interval, 1.6-24.2; p=0.008). Ki-67 and survivin correlated with histological grade but not with outcome. Immunohistochemical detection of the RTK-I family did not correlate with grade or outcome. Telomerase activity was evident in 19 of 22 primary tumors, with telomere lengthening and/or maintenance occurring in five of seven recurrent cases. Low nucleolin expression was the single most important biological predictor of outcome in pediatric intracranial ependymoma. Furthermore, telomerase reactivation and maintenance of telomeric repeats appear necessary for childhood ependymoma progression. These findings require corroboration in a clinical trial setting.