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Specific, Sensitive, and Quantitative Enzyme-Linked Immunosorbent Assay for Human Immunoglobulin G Antibodies to Anthrax Toxin Protective Antigen

机译:人体免疫球蛋白G抗体对炭疽毒素保护性抗原的特异性,灵敏和定量酶联免疫吸附测定

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The bioterrorism-associated human anthrax epidemic in the fall of 2001 highlighted the need for a sensi-tive, reproducible, and specific laboratory test for the confirmatory diagnosis of human anthrax. The Cen-ters for Disease Control and Prevention developed,optimized, and rapidly qualifiedan enzyme-linkedimmunosorbent assay (ELISA) for immunoglobulin G (IgG) antibodies to Bacillus anthracis protective anti-gen (PA) in human serum. The qualifiedELISA had a minimum detection limit of 0.06 μg/mL, a reliablelower limit of detection of 0.09 μg/mL, and a lower limit of quantification in undiluted serum specimens of3.0 μg/mL anti-PA IgG. The diagnostic sensitivity of the assay was 97.8%, and the diagnostic specificitywas 97.6%. A competitive inhibition anti-PA IgG ELISA was also developed to enhance diagnostic speci-ficity to 100%. The anti-PA ELISAs proved valuable for the confirmation of cases of cutaneous and inhala-tional anthrax and evaluation of patients in whom the diagnosis of anthrax was being considered
机译:2001年秋天,与生物恐怖主义相关的人类炭疽病疫情突出表明,需要有灵敏,可再现且特定的实验室测试来确证诊断人类炭疽病。疾病控制和预防中心开发,优化并快速鉴定了酶联免疫吸附测定(ELISA),用于检测人血清中炭疽芽孢杆菌保护性抗原(PA)的免疫球蛋白G(IgG)抗体。合格的ELISA的最低检测下限为0.06μg/ mL,可靠的检测下限为0.09μg/ mL,未稀释血清样品中的抗PA IgG定量下限为3.0μg/ mL。该方法的诊断敏感性为97.8%,诊断特异性为97.6%。还开发了竞争性抑制性抗PA IgG ELISA,以将诊断特异性提高到100%。事实证明,抗PA ELISAs对于确认皮肤和吸入性炭疽病例以及评估考虑诊断炭疽的患者具有重要价值。

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