Grabau J C, DiFerdinando G T, Novick L F
Bureau of Tuberculosis Control, New York State Department of Health, Albany 12237-0627, USA.
Public Health Rep. 1995 Nov-Dec;110(6):703-6.
The re-emergence of tuberculosis as a significant public health threat has led to greatly renewed activity in tuberculin skin testing to identify infected persons. However, even use of the preferred skin test technique (intradermal injection of purified protein derivative via the Mantoux method) can lead to either false positive or false negative results. Interpretation of a Mantoux test can be influenced by cross reactions with other mycobacteria, intertester variation, host-response variation, and product related problems. At least 25 apparent false positive purified protein derivative skin test reactions in New York State in 1992 appeared to be associated with lots of the derivative produced by one manufacturer. These unexpected skin test results led to examination of a product with an altered appearance that may have caused the unanticipated responses. After announcement of these false positive results to the press, the company removed the product from the market. Food and Drug Administration analysis later revealed particulate matter in vials of the suspected lots of purified protein derivative.
结核病再度成为重大的公共卫生威胁，这使得结核菌素皮肤试验以识别感染者的活动大幅增加。然而，即使使用首选的皮肤试验技术（通过曼托试验法皮内注射纯化蛋白衍生物）也可能导致假阳性或假阴性结果。曼托试验的解读可能会受到与其他分枝杆菌的交叉反应、测试者之间的差异、宿主反应差异以及产品相关问题的影响。1992年纽约州至少有25例明显的纯化蛋白衍生物皮肤试验假阳性反应似乎与某一制造商生产的该衍生物批次有关。这些意外的皮肤试验结果促使人们对外观改变的产品进行检查，而这种改变可能导致了这些意外反应。在向媒体公布这些假阳性结果后，该公司将该产品撤出市场。美国食品药品监督管理局后来的分析发现，疑似批次的纯化蛋白衍生物小瓶中有颗粒物。
