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Biological potency of German cockroach allergen extracts determined in an inner city population.

机译:在市区内人口中测定的德国蟑螂过敏原提取物的生物效力。

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Background Cockroach allergy is an important cause of inner city asthma. To perform valid studies on the diagnosis and treatment of cockroach allergy, biological potencies of test extracts need to be established, and a surrogate in vitro test for biological potency should be chosen. Methods Sixty-two cockroach-allergic adult subjects were recruited for quantitative skin testing with three commercial German cockroach extracts. The intradermal D50 values were determined using linear interpolation, and the biologic potencies were determined from D50 data. The extracts were also analysed for relative potency, using a competition ELISA, and for specific allergen content, using a two-site ELISA. Results Estimates of each extract's D50 were analysable in 48-55 subjects, with D50s between 10.3 and 11.8. All three extracts were bioequivalent using pre-set criteria. The biological potencies of the extracts were 1738-8570 bioequivalent allergy units (BAU)/mL (geometric mean=3300), and these relative potencies were similar to those estimated by competition ELISA and specific allergen content. IgE against cockroach allergens were detected in sera from 34 subjects with analysable D50s, and 17 subjects had IgE directed against specific cockroach allergens. Although the presence of anti-Bla g 5 correlated with the subjects' skin test responses for 2/3 extracts, no single allergen was immunodominant. Antibody responses among the subjects were heterogeneous. Conclusions Although commercial cockroach extracts are relatively low in potency, immunotherapeutic doses should be achievable. Biological potency may be estimated using D50 testing, a combination of specific allergen determinations, or by an overall potency assay such as the competition ELISA. Capsule Summary The biological potency of three German cockroach allergen extracts, determined in an inner city population, was 1738-8570 BAU/mL. No one allergen was immunodominant, and surrogate in vitro testing methods were examined.
机译:背景蟑螂过敏是城市内哮喘的重要原因。为了进行有效的蟑螂过敏诊断和治疗研究,需要建立测试提取物的生物效价,并应选择替代的生物效价体外测试。方法招募了62名对蟑螂过敏的成人受试者,用3种市售德国蟑螂提取物进行了定量皮肤测试。使用线性内插法确定皮内D50值,并根据D50数据确定生物效力。还使用竞争ELISA分析提取物的相对效价,并使用两点ELISA分析特异性过敏原含量。结果在48-55位受试者中,每种提取物的D50估计值均可分析,D50在10.3至11.8之间。使用预设标准,所有三种提取物均具有生物等效性。提取物的生物效价为1738-8570生物等效过敏单位(BAU)/ mL(几何平均值= 3300),并且这些相对效价与竞争ELISA和特定过敏原含量估算的相对效价相似。从可分析D50的34名受试者的血清中检测到了针对蟑螂过敏原的IgE,并且17名受试者针对了特定的蟑螂过敏原。尽管抗Bla g 5的存在与受试者对2/3提取物的皮肤测试反应相关,但没有任何一种过敏原具有免疫优势。受试者之间的抗体反应是异质的。结论尽管商业蟑螂提取物的效力相对较低,但仍应可以达到免疫治疗剂量。可以使用D50测试,特定变应原测定的组合或通过整体效价测定(例如竞争ELISA)来估算生物效价。胶囊总结在市区内人群中测定的三种德国蟑螂过敏原提取物的生物效价为1738-8570 BAU / mL。没有一种过敏原具有免疫优势,因此研究了替代体外测试方法。

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