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采用体外全血培养试验检测血液制品中的热原。

The detection of pyrogens in blood products using an ex vivo whole blood culture assay.

作者信息

Pool E J, Johaar G, James S, Petersen I, Bouic P

机构信息

Western Province Blood Transfusion Service, Parow, South Africa.

出版信息

J Immunoassay. 1998 May-Aug;19(2-3):95-111. doi: 10.1080/01971529808005475.

DOI:10.1080/01971529808005475
PMID:9682126
Abstract

Induction of interleukin-6 (IL-6) secretion by whole blood cultures (WBC) was used as an in vitro assay system for pyrogen-induced inflammatory reactions. The assay system was very sensitive to Eschericia coli (E coli) endotoxin (< 10 pg/ml). The potential pyrogenic effects of human serum albumin (HSA), Fibronectin (Fn) and stabilised human serum (SHS) solutions were analyzed using this system. None of the products assayed had an effect on the sensitivity of the WBC assay. Spike recovery studies with isolated endotoxin, gram positive and gram negative bacteria showed that none of the products had an effect on the spike recovery of these pyrogenic substances. Good correlations were found between the WBC assay and the rabbit assay for pyrogens for all the production batches tested. When these samples were analysed by the limulus amoebocyte lysate (LAL) assay, the LAL test gave anomalous results for 1 out of the 22 production batches tested. This batch gave a false negative result on the LAL assay and might be indicative of the inability of the LAL assay to detect pyrogens other than endotoxin.

摘要

全血培养(WBC)诱导白细胞介素-6(IL-6)分泌被用作热原诱导炎症反应的体外检测系统。该检测系统对大肠杆菌(E coli)内毒素非常敏感(<10 pg/ml)。使用该系统分析了人血清白蛋白(HSA)、纤连蛋白(Fn)和稳定化人血清(SHS)溶液的潜在致热作用。所检测的产品均未对WBC检测的敏感性产生影响。对分离的内毒素、革兰氏阳性菌和革兰氏阴性菌进行的加标回收率研究表明,这些产品均未对这些热原性物质的加标回收率产生影响。在所测试的所有生产批次中,WBC检测与兔热原检测之间发现了良好的相关性。当通过鲎试剂法(LAL)分析这些样品时,在22个测试生产批次中,LAL检测对其中1个批次给出了异常结果。该批次在LAL检测中给出了假阴性结果,这可能表明LAL检测无法检测除内毒素以外的热原。

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