Harris E N, Pierangeli S S
Morehouse School of Medicine, Atlanta, Georgia 30310-1495, USA.
Lupus. 2002;11(5):269-75. doi: 10.1191/0961203302lu202cr.
Although the importance of the anticardiolipin test in diagnosis of antiphospholipid syndrome (APS) is widely accepted, there remains much misunderstanding about the strengths and weaknesses of this assay. Several disorders result in formation of low levels of the antibody, hence the anticardiolipin test is not specific when results are low positive. In general, the higher the anticardiolipin level the greater the likelihood of a diagnosis of APS. Hence there have been numerous efforts to enable reproducible measurement of anticardiolipin levels. Standard calibrators were introduced to construct calibration curves from which levels of unknown samples can be derived. Those standard calibrators were made by mixing varying quantities of high positive with normal sera. More recently, calibrators derived from monoclonal anticardiolipin antibodies have been introduced. There are advantages and disadvantages with both types of calibrators. Determination of a precise and reproducible anticardiolipin level is difficult, whatever the calibrators used, because the assay is dependent on several variable components, any of which may fail on any given day. Utilization of a semi-quantitative measure (low, medium, high) may suffice in most clinical settings and would be less subject to error. Validated ELISA kits may offer greater reproducibility, since there is less variability than bench assays set up in very different laboratories. Whether using a kit or a bench assay, meticulous attention to detail offers the best opportunity for precision and reproducibility.
尽管抗心磷脂检测在抗磷脂综合征（APS）诊断中的重要性已被广泛认可，但对于该检测方法的优缺点仍存在诸多误解。多种疾病会导致低水平抗体的形成，因此当抗心磷脂检测结果为低阳性时，该检测并不具有特异性。一般来说，抗心磷脂水平越高，诊断为APS的可能性就越大。因此，人们为实现抗心磷脂水平的可重复性测量付出了诸多努力。引入了标准校准品来构建校准曲线，从而能够得出未知样本的水平。那些标准校准品是通过将不同量的高阳性血清与正常血清混合制成的。最近，源自单克隆抗心磷脂抗体的校准品也已被引入。这两种校准品都有其优缺点。无论使用哪种校准品，准确测定可重复的抗心磷脂水平都很困难，因为该检测依赖于多个可变因素，其中任何一个因素在任何给定的日子都可能出现问题。在大多数临床情况下，使用半定量测量（低、中、高）可能就足够了，而且误差会更小。经过验证的酶联免疫吸附测定（ELISA）试剂盒可能具有更高的可重复性，因为与在非常不同的实验室中设立的手工检测相比，其变异性更小。无论是使用试剂盒还是手工检测，对细节的精心关注都为实现精确性和可重复性提供了最佳机会。
