Stevens R W, Schmitt M E
J Clin Microbiol. 1985 Mar;21(3):399-402. doi: 10.1128/jcm.21.3.399-402.1985.
A new enzyme-linked immunosorbent assay with Treponema pallidum antigen bound to ferrous metal beads (Syphilis Bio-EnzaBead; Litton Bionetics Laboratory Products) was compared with the standard fluorescent treponemal antibody-absorption test for syphilis. Bio-EnzaBead and fluorescent treponemal antibody-absorption tests were done on 218 specimens from documented cases of syphilis, on 315 sera from individuals with diseases other than syphilis, and on sera submitted to a public health laboratory for premarital (304 specimens) or diagnostic (501 specimens) tests for syphilis. Agreement between the Bio-EnzaBead and reference tests ranged from 93.0% for sera for the diagnostic test to 99.5% for sera from patients with syphilis. The overall agreement among the 1,338 sera tested was 96.3%. The reproducibility of the Bio-EnzaBead test with 60 coded sera of graded reactivity was 97%. The test is easy to perform, the indicator results are clear and unequivocal, and the findings are comparable to those of the fluorescent treponemal antibody-absorption test.
一种将梅毒螺旋体抗原与黑色金属珠结合的新型酶联免疫吸附试验(梅毒生物酶珠试验;利顿生物工程实验室产品)与梅毒标准荧光密螺旋体抗体吸收试验进行了比较。对218份确诊梅毒病例的标本、315份非梅毒患者的血清以及提交给公共卫生实验室进行婚前(304份标本)或梅毒诊断(501份标本)检测的血清进行了梅毒生物酶珠试验和荧光密螺旋体抗体吸收试验。梅毒生物酶珠试验与参比试验之间的一致性,在诊断检测血清中为93.0%,在梅毒患者血清中为99.5%。在检测的1338份血清中,总体一致性为96.3%。用60份反应性分级的编码血清进行的梅毒生物酶珠试验的重复性为97%。该试验操作简便,指示结果清晰明确,且结果与荧光密螺旋体抗体吸收试验的结果相当。