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

Journal of immunoassay Pub Date : 1998-05-01 DOI:10.1080/01971529808005475

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

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引用次数: 40

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.

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用离体全血培养法检测血液制品中的热原。

采用全血培养(WBC)诱导白细胞介素-6 (IL-6)分泌作为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内毒素(< 10 pg/ml)非常敏感。利用该系统分析了人血清白蛋白(HSA)、纤连蛋白(Fn)和稳定人血清(SHS)溶液的潜在热原效应。所有检测的产物对白细胞检测的灵敏度都没有影响。对分离的内毒素、革兰氏阳性菌和革兰氏阴性菌进行穗回收率研究表明，这些产物对这些热原物质的穗回收率没有影响。在所测试的所有生产批次中，白细胞测定法和兔热原测定法之间存在良好的相关性。当用鲎试剂(LAL)分析这些样品时，在22个生产批次中，LAL检测给出了1个异常结果。这批LAL检测结果为假阴性，可能表明LAL检测不能检测除内毒素以外的热原。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Journal of immunoassay

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