Ratnam S, Stead F, Head C B
Newfoundland and Labrador Public Health Laboratory, St. John's, Newfoundland, Canada.
J Clin Microbiol. 1989 Sep;27(9):2102-4. doi: 10.1128/jcm.27.9.2102-2104.1989.
Nonspecific hepatitis B surface antigen reactions with a third-generation enzyme immunoassay (Auszyme Monoclonal; Abbott Laboratories, North Chicago, Ill.) were investigated with 9,577 serum specimens in a clinical laboratory setting. Of the 196 serum specimens found reactive in Auszyme screen by the overnight procedure, 103 turned out to be true-positives, 71 were nonrepeatably reactive, and 22 were repeatably reactive but actually falsely positive (false-positive rate, 22 of 196, or 11.2%). Verification of the 196 screen reactives by the Auszyme 3-h incubation assay detected all but 4 true-positives, with a false-negative rate of 3.9% (4 of 103), and was negative for the rest. These observations reinforce the need for retesting all reactive specimens and confirming repeatedly reactive samples when the Auszyme Monoclonal test is used to detect hepatitis B surface antigen.
在临床实验室环境中，使用9577份血清标本对第三代酶免疫测定法（Auszyme单克隆法；雅培实验室，伊利诺伊州北芝加哥）检测乙型肝炎表面抗原的非特异性反应进行了研究。在通过过夜程序在Auszyme筛查中发现反应性的196份血清标本中，103份结果为真阳性，71份反应性不可重复，22份反应性可重复但实际为假阳性（假阳性率为196份中的22份，即11.2%）。通过Auszyme 3小时孵育测定法对196份筛查反应性标本进行验证，除4份真阳性标本外均检测到，假阴性率为3.9%（103份中的4份），其余均为阴性。这些观察结果强化了在使用Auszyme单克隆试验检测乙型肝炎表面抗原时对所有反应性标本进行重新检测并确认反复反应性样本的必要性。
