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Latex allergy: the sum quantity of four major allergens shows the allergenic potential of medical gloves.

机译：乳胶过敏：四种主要过敏原的总和显示出医用手套的潜在致敏性。

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Background: Assessment of allergenic potential of medical devices made of natural rubber latex (NRL) requires the measurement of concentrations of specific allergenic proteins or polypeptides eluting from rubber. Methods: Four NRL allergens (Hev b 1, 3, 5, and 6.02) were quantified in all medical glove brands marketed in Finland in 1999, 2001, and 2003 (n = 208) by a capture enzyme immunoassay. The results were compared with those obtained from previous nationwide market surveys, using a skin prick test-validated human IgE-based ELISA-inhibition method. Results: A high overall correlation (r = 0.87, 95% CI 0.83-0.90) emerged between the sum values of the four allergens(mug/g glove) and IgE-ELISA inhibition (allergen units, AU/ml, 1 : 5 diluted glove extract). The sum of four allergens when set at 0.15 mug/g discriminated 'low allergenic' (<10 AU/ml) from 'moderate- to high-allergenic' (>/=10 AU/ml) gloves at a sensitivity of 0.93 (95% CI 0.85-0.98) and specificity of 0.90 (95% CI 0.83-0.94). When the sum was below the detection limit (0.03 mug/g) all gloves belonged to the previously defined low-allergen category. Conclusions: By comparing the sum concentration of four selected NRL allergens with results obtained in human IgE-ELISA inhibition, it was possible set a cut-off level (0.15 mug/g) below which virtually all gloves contain low or insignificant amounts of allergens, and can be considered as low allergenic. At different cut-off-points, one could calculate the likelihood of a given glove to belong to the previously defined low, moderate or high allergen categories.
机译：背景：评估天然橡胶胶乳（NRL）制成的医疗设备的致敏潜力需要测量从橡胶洗脱的特定致敏蛋白质或多肽的浓度。方法：通过捕获酶免疫分析法对1999、2001和2003年在芬兰销售的所有医用手套品牌中的四种NRL过敏原（Hev b，3、5和6.02）进行了定量（n = 208）。使用皮肤点刺试验验证的基于人IgE的ELISA抑制方法，将结果与从先前的全国市场调查中获得的结果进行了比较。结果：四种过敏原（杯子/克手套）和IgE-ELISA抑制（过敏原单位，AU / ml，1：5稀释）之间的总相关性高（r = 0.87，95％CI 0.83-0.90）手套提取物）。设置为0.15杯/克时，四种过敏原的总和将“低致敏”（<10 AU / ml）手套从“中致敏”到“高致敏”（> / = 10 AU / ml）手套区分开，灵敏度为0.93（95 ％CI 0.85-0.98）和特异性0.90（95％CI 0.83-0.94）。当总和低于检出限（0.03杯/克）时，所有手套均属于先前定义的低过敏原类别。结论：通过将四种选定的NRL过敏原的总浓度与人IgE-ELISA抑制结果进行比较，可以设定一个临界水平（0.15杯/克），在该临界水平以下，几乎所有手套都含有少量或无关紧要的过敏原，并且可以认为是低致敏性的。在不同的临界点，可以计算出给定手套属于先前定义的低，中或高过敏原类别的可能性。

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