Peaceman A M, Silver R K, MacGregor S N, Socol M L
Department of Obstetrics and Gynecology, Northwestern University Medical School, Chicago, IL 60611.
Am J Obstet Gynecol. 1992 Jun;166(6 Pt 1):1780-4; discussion 1784-7. doi: 10.1016/0002-9378(92)91569-v.
Because of the widespread use of antiphospholipid antibody testing in the evaluation of patients with recurrent pregnancy loss, we evaluated the consistency of results among laboratories testing for anticardiolipin antibody and the lupus anticoagulant.
A questionnaire regarding methods used and samples of blood from 20 patients were sent to five university-based and five commercial facilities for antiphospholipid antibody testing.
The responses of the participating laboratories to the questionnaires revealed significant differences in methods, standardization, and units of reporting. For anticardiolipin antibody, the number of specimens found to be positive for any isotype (immunoglobulin G, M, or A) varied considerably among laboratories, with a range of 5 to 13. All laboratories were in agreement (i.e., at least one isotype was present or all were absent) for only 5 of 20 specimens (25%). In contrast, lupus anticoagulant results were more reproducible, although one facility reported results markedly discordant from the other four laboratories.
These observations suggest that significant interlaboratory variation exists in antiphospholipid antibody, and particularly anticardiolipin antibody, testing and might lead to unnecessary therapeutic interventions.
鉴于抗磷脂抗体检测在复发性流产患者评估中的广泛应用,我们评估了检测抗心磷脂抗体和狼疮抗凝物的实验室之间结果的一致性。
向五家大学附属医院和五家商业机构发送了一份关于检测方法和来自20名患者的血样的调查问卷,用于抗磷脂抗体检测。
参与调查的实验室对问卷的回复显示,在方法、标准化和报告单位方面存在显著差异。对于抗心磷脂抗体,各实验室检测出任何一种亚型(免疫球蛋白G、M或A)呈阳性的标本数量差异很大,范围为5至13。20份标本中只有5份(25%)所有实验室的结果一致(即至少有一种亚型存在或均不存在)。相比之下,狼疮抗凝物的检测结果更具可重复性,尽管有一家机构报告的结果与其他四家实验室明显不同。
这些观察结果表明,抗磷脂抗体检测,尤其是抗心磷脂抗体检测,在实验室之间存在显著差异,可能会导致不必要的治疗干预。