Palosuo T, Mäkinen-Kiljunen S, Alenius H, Reunala T, Yip E, Turjanmaa K
National Public Health Institute, Helsinki, Finland.
Allergy. 1998 Jan;53(1):59-67. doi: 10.1111/j.1398-9995.1998.tb03774.x.
Exposure to natural rubber latex (NRL) medical gloves poses risks to patients sensitized to NRL and to users of protective gloves. Previous studies have shown that extractable allergen levels of the gloves vary widely. Since most of the available laboratory methods of NRL allergen measurement lack adequate validation, we wanted to evaluate the performance of a recently developed competitive IgE-ELISA-inhibition method in relation to the skin prick test (SPT) and RAST inhibition, as well as to extractable protein quantification and an immunochemical latex antigen assay (LEAP). Twenty samples of surgical (n = 14) and examination gloves (n = 6), covering > 90% of medical gloves marketed in Finland in 1994-5, were collected by the Finnish National Research and Development Centre for Welfare and Health, coded, extracted, and analyzed by the five methods. The IgE-ELISA inhibition correlated highly significantly with SPT (r = 0.94) and RAST inhibition (r = 0.96). Likewise, ELISA inhibition and RAST inhibition showed highly significant correlation (P = 0.96, P < 0.0001 in all three instances). Protein quantification by a modified Lowry method also correlated highly significantly with SPT (r = 0.80), RAST inhibition (r = 0.82), and ELISA inhibition (r = 0.81, P < 0.0001 in all three instances). Clearly weaker correlation, though statistically significant (r = 0.48, P = 0.03), was found between SPT and the LEAP assay. An NRL standard preparation was assigned an arbitrary content of 100,000 allergen units (AU) per ml. In relation to this standard, the NRL allergen level was considered low (< 10 AU/ml) in 11, moderate (10-100 AU/ml) in two, and high (> 100 AU/ml) in seven of the 20 glove brands analyzed. In conclusion, the results of a novel IgE-ELISA-inhibition method of measuring NRL allergen levels in medical gloves correlated highly significantly with those of SPT. The ELISA method was found to be sensitive, reproducible, technically easy, inexpensive, and suitable for the analysis of large numbers of NRL products. The results of extensive market surveys in 1994 and 1995, communicated to the medical community in Finland, appear to have had a clear effect in moving glove purchasing policies toward the use of low-allergen gloves.
接触天然橡胶乳胶（NRL）医用手套会对NRL敏感患者及防护手套使用者构成风险。以往研究表明，手套中可提取的过敏原水平差异很大。由于现有的大多数NRL过敏原测量实验室方法缺乏充分验证，我们希望评估一种最近开发的竞争性IgE - ELISA抑制法相对于皮肤点刺试验（SPT）、RAST抑制法，以及可提取蛋白定量和免疫化学乳胶抗原测定法（LEAP）的性能。芬兰国家福利与健康研究发展中心收集了20份手术手套（n = 14）和检查手套（n = 6）样本，涵盖了1994 - 1995年在芬兰市场上销售的90%以上的医用手套，进行编码、提取，并通过这五种方法进行分析。IgE - ELISA抑制法与SPT（r = 0.94）和RAST抑制法（r = 0.96）高度显著相关。同样，ELISA抑制法和RAST抑制法也显示出高度显著的相关性（P = 0.96，在所有三种情况下P < 0.0001）。改良的Lowry法进行的蛋白定量也与SPT（r = 0.80）、RAST抑制法（r = 0.82）和ELISA抑制法（r = 0.81，在所有三种情况下P < 0.0001）高度显著相关。虽然在统计学上显著（r = 0.48，P = 0.03），但SPT与LEAP测定之间的相关性明显较弱。将一种NRL标准制剂指定为每毫升含有100,000个过敏原单位（AU）的任意含量。相对于该标准，在分析的20个手套品牌中，有11个品牌的NRL过敏原水平被认为较低（< 10 AU/ml），2个品牌为中等（10 - 100 AU/ml），7个品牌为高（> 100 AU/ml）。总之，一种用于测量医用手套中NRL过敏原水平的新型IgE - ELISA抑制法的结果与SPT的结果高度显著相关。ELISA法被发现具有敏感性、可重复性、技术操作简便、成本低廉，且适合分析大量NRL产品。1994年和1995年广泛的市场调查结果传达给了芬兰医学界，似乎对将手套采购政策转向使用低过敏原手套产生了明显影响。
