雅培AxSym总β-人绒毛膜促性腺激素检测假阳性缺陷的临床实验室简易解决方法。
Easy fix for clinical laboratories for the false-positive defect with the Abbott AxSym total beta-hCG test.
作者信息
Cole Laurence A, Khanlian Sarah A
机构信息
Department of Obstetrics and Gynecology, USA hCG Reference Service, University of New Mexico, Albuquerque, NM 87131, USA.
出版信息
Clin Biochem. 2004 May;37(5):344-9. doi: 10.1016/j.clinbiochem.2004.03.001.
BACKGROUND
False-positive hCG results can lead to erroneous diagnoses and needless chemotherapy and surgery. In the last 2 years, eight publications described cases involving false-positive hCG tests; all eight involved the AxSym test. We investigated the source of this abundance of cases and a simple fix that may be used by clinical laboratories.
METHODS
False-positive hCG was primarily identified by absence of hCG in urine and varying or negative hCG results in alternative tests. Seventeen false-positive serum samples in the AxSym test were evaluated undiluted and at twofold dilution with diluent containing excess goat serum or immunoglobulin.
RESULTS
We identified 58 patients with false-positive hCG, 47 of 58 due to the Abbott AxSym total hCGbeta test (81%). Sixteen of 17 of these "false-positive" results (mean 100 mIU/ml) became undetectable when tested again after twofold dilution.
CONCLUSIONS
A simple twofold dilution with this diluent containing excess goat serum or immunoglobulin completely protected 16 of 17 samples from patients having false-positive results. It is recommended that laboratories using this test use twofold dilution as a minimum to prevent false-positive results.
背景
人绒毛膜促性腺激素（hCG）检测结果呈假阳性会导致错误诊断以及不必要的化疗和手术。在过去两年中，有八篇文献描述了涉及hCG检测结果假阳性的病例；所有八例均涉及AxSym检测。我们调查了大量此类病例的根源以及临床实验室可能采用的一种简单解决办法。
方法
hCG检测结果假阳性主要通过尿液中无hCG以及替代检测中hCG结果各异或呈阴性来确定。对AxSym检测中17份假阳性血清样本进行了原液检测，并使用含有过量山羊血清或免疫球蛋白的稀释液进行了两倍稀释检测。
结果
我们识别出58例hCG检测结果假阳性患者，其中58例中有47例（81%）是由于雅培AxSym总hCGβ检测导致的。这17份“假阳性”结果中的16份（平均100 mIU/ml）在两倍稀释后再次检测时变为不可检测。
结论
使用含有过量山羊血清或免疫球蛋白的稀释液进行简单的两倍稀释可使17份样本中的16份完全避免出现假阳性结果。建议使用该检测方法的实验室至少采用两倍稀释以防止出现假阳性结果。
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