Gerber M A, Wright L L, Randolph M F
Pediatr Infect Dis J. 1987 Jan;6(1):36-40. doi: 10.1097/00006454-198701000-00010.
The ability of the Streptozyme test to identify significant antibody rises in 46 patients with streptococcal pharyngitis was comparable to, but no greater than, that of the antistreptolysin O or antideoxyribonuclease B test and inferior to that of the combined use of both the antistreptolysin O and antideoxyribonuclease B tests. Serum specimens were also simultaneously analyzed with three different lots of Streptozyme reagent. Lot-to-lot variation in the reagent resulted in a significant difference in antibody titer for 18 (19%) of the 92 sera tested. Differences among the three lots also produced variation in determining whether a significant rise in titer had occurred from the acute phase to the convalescent phase serum for a given patient. These observations raise concerns about the standardization of the Streptozyme reagent and document the need for precise identification and quantitation of the streptococcal antigens used in this product.
链球菌酶试验识别46例链球菌性咽炎患者显著抗体升高的能力,与抗链球菌溶血素O或抗脱氧核糖核酸酶B试验相当,但不超过它们,且低于抗链球菌溶血素O和抗脱氧核糖核酸酶B试验联合使用的能力。血清标本还同时用三批不同的链球菌酶试剂进行分析。试剂的批次间差异导致92份检测血清中的18份(19%)抗体滴度出现显著差异。三批试剂之间的差异还导致在确定给定患者从急性期到恢复期血清抗体滴度是否有显著升高时出现差异。这些观察结果引发了对链球菌酶试剂标准化的担忧,并证明了对该产品中使用的链球菌抗原进行精确鉴定和定量的必要性。