Evaluation of the anti-cardiolipin antibody test: report of an international workshop held 4 April 1986.

Evaluation of the anti-cardiolipin antibody test: report of an international workshop held 4 April 1986.
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抗心磷脂抗体测试的评估:1986 年 4 月 4 日举行的国际研讨会的报告。

DOI:
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发表时间:
1987
影响因子:
4.6
通讯作者:
G. Hughes
G. Hughes
中科院分区:
医学3区
文献类型:
--
作者:
E. Harris;A. Gharavi;S. P. Patel;G. Hughes

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来自英国、法国、意大利、荷兰、新西兰、瑞典和美国机构的30个实验室参加了一次评估抗心磷脂(aCL)测试的研讨会。参与者被要求在三天内分别测量七个样本中的IgG和IgM aCL。对7份样品进行了准备,以便在分发前了解IgG和IgM aCL的浓度。当光学吸光度读数或每分钟计数与IgG aCL浓度比较时,30个测量IgG aCL的实验室中有23个具有显著的回归斜率(P < 0.001)。28个检测IgM aCL的实验室中有24个有显著的回归斜率(P < 0.001)。IgG aCL检测的检测系数(R2)为81.1% ~ 98.7%,IgM aCL检测的检测系数为48.0% ~ 96.7%。有效的测定通常在PBS中使用10%的胎牛或10%的成年牛血清。无效的测定通常使用PBS、PBS-吐温或0.3%明胶作为稀释剂。所有具有有效测定方法的实验室都将高和中等水平的aCL定义为阳性,但对低水平的阳性样本没有共识。本研究表明,正确执行ELISA或SRIA检测可用于提供血清样品中IgG和IgM aCL浓度的准确,可重复性和定量测量。
Thirty laboratories from institutions in Britain, France, Italy, The Netherlands, New Zealand, Sweden and the USA participated in a workshop to evaluate the anti-cardiolipin (aCL) test. Participants were asked to measure IgG and IgM aCL in seven samples on each of three separate days. The seven samples were prepared so that IgG and IgM aCL concentrations were known before distribution. Twenty-three of 30 laboratories measuring IgG aCL had significant regression slopes (P less than 0.001) when optical absorbance readings or counts per minute were compared with IgG aCL concentration. Twenty-four of 28 laboratories measuring IgM aCL had significant regression slopes (P less than 0.001). Coefficient of determination (R2) ranged from 81.1% to 98.7% for laboratories with valid IgG aCL assays and from 48.0% to 96.7% for valid IgM aCL assays. Valid assays had in common the use of 10% fetal calf or 10% adult bovine serum in PBS. Assays that were not valid had in common the use of PBS, PBS-Tween, or 0.3% gelatin as diluents. All laboratories with valid assays defined samples with high and moderate aCL levels as positive but there was no consensus about low positive samples. This study shows that properly performed ELISA or SRIA assays can be used to provide an accurate, reproducible, and quantitative measure of IgG and IgM aCL concentration in serum samples.