梅毒生物酶珠试验的评估
Evaluation of the Bio-EnzaBead test for syphilis.
作者信息
Moyer N P, Hudson J D, Hausler W J
出版信息
J Clin Microbiol. 1987 Apr;25(4):619-23. doi: 10.1128/jcm.25.4.619-623.1987.
The sensitivity and specificity of the Bio-EnzaBead test for syphilis and the fluorescent treponemal antibody-absorption (FTA-ABS) test were determined by examining 262 serum samples, including 202 serum samples from patients with confirmed syphilis in various stages. Overall correlation with patient history was 95.8% with both tests. False-negative Bio-EnzaBead tests occurred in 9 of 86 (10.5%) cases of late-latent syphilis (greater than 2 years) and in 1 of 38 (2.6%) cases for which the stage of disease could not be determined. False-negative FTA-ABS tests occurred in 5 of 86 (5.8%) cases of late-latent syphilis (greater than 2 years) and in 2 of 38 (5.3%) cases for which the stage of disease could not be determined. One false-positive test occurred with Bio-EnzaBead, and the cause could not be determined. The reproducibility of the Bio-EnzaBead test was excellent when spectrophotometric readings were calibrated against either air or substrate blanks. The Bio-EnzaBead test for syphilis is a suitable alternative to the FTA-ABS test.
通过检测262份血清样本，包括202份来自各期确诊梅毒患者的血清样本，确定了梅毒Bio-EnzaBead检测和荧光密螺旋体抗体吸收（FTA-ABS）检测的敏感性和特异性。两种检测与患者病史的总体相关性均为95.8%。在86例晚期潜伏梅毒（超过2年）病例中有9例（10.5%）以及在38例无法确定疾病分期的病例中有1例（2.6%）出现Bio-EnzaBead检测假阴性。在86例晚期潜伏梅毒（超过2年）病例中有5例（5.8%）以及在38例无法确定疾病分期的病例中有2例（5.3%）出现FTA-ABS检测假阴性。Bio-EnzaBead检测出现1例假阳性，原因无法确定。当分光光度读数针对空气或底物空白进行校准时，Bio-EnzaBead检测的重复性极佳。梅毒Bio-EnzaBead检测是FTA-ABS检测的合适替代方法。
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