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首页> 外文期刊>Clinical and diagnostic laboratory immunology >Collaborative study for the evaluation of enzyme-linked immunosorbent assays used to measure human antibodies to Bordetella pertussis antigens.
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Collaborative study for the evaluation of enzyme-linked immunosorbent assays used to measure human antibodies to Bordetella pertussis antigens.

机译：评估酶联免疫吸附测定法的协作研究，该测定法用于测量针对百日咳博德特氏菌抗原的人抗体。

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Acellular pertussis vaccines are being evaluated in multiple clinical studies, and human immunogenicity data will likely be pivotal in the appraisal of vaccine responses between populations and the responses to different vaccine combinations. Antibody response to pertussis antigens is also used in the diagnosis of pertussis. An international study was designed to assess the comparability of data generated in different laboratories by enzyme-linked immunosorbent assays (ELISAs). Thirty-three participating laboratories were asked to quantitate specific antibody to pertussis toxin (PT), filamentous hemagglutinin (FHA), pertactin (PRN), or fimbrial proteins (FIM) in 21 samples. Samples were to be assayed in triplicate in five independent assays by each ELISA routinely performed in the laboratory to assess intra-assay, interassay, and population variability. The mean sample values were used to compare quantitative results among the laboratories. Thirteen of the 32 laboratories which submitted evaluable data for an assay to measure antibodies to PT, 12 of 30 laboratories with assays for FHA, 10 of 17 laboratories with assays for PRN, and 6 of 13 laboratories with assays for FIM maintained a coefficient of variation below 20% for 75% of the samples tested. Assays that measure antibodies to FIM appear to be less precise than the other assays. Precision varied among laboratories that used similar methods. The relative values of intra- and interassay variabilities were not consistent for a given assay within a laboratory, indicating that the sources of these variability components may be unrelated. Precision and agreement appeared less reliable for samples with low antibody levels. Ranking and regression analyses suggest that some laboratories generated comparable quantitative results, although direct comparison or combination of results from different laboratories remains difficult to support. Calibration to the U.S. Reference Pertussis Antisera appears to have been successful at standardizing the results in some laboratories. Statistical analyses are affected by assay precision and are not necessarily reliable sole predictors of biologically relevant differences in quantitative results. If results from different laboratories must be compared, appropriate studies of precision and quantitative agreement should be conducted to support the specific comparisons.
机译：无细胞百日咳疫苗正在多项临床研究中进行评估，人类免疫原性数据可能在评估人群之间的疫苗反应以及对不同疫苗组合的反应中至关重要。对百日咳抗原的抗体应答也用于百日咳的诊断。设计了一项国际研究，以评估通过酶联免疫吸附测定（ELISA）在不同实验室中产生的数据的可比性。要求33个参与实验室对21种样品中的百日咳毒素（PT），丝状血凝素（FHA），百日咳杆菌粘附素（PRN）或纤维蛋白（FIM）的特异性抗体进行定量。将通过在实验室中常规进行的每种ELISA在五个独立的测定中一式三份地测定样品，以评估测定内，测定间和群体变异性。平均样本值用于比较实验室之间的定量结果。提交可评估数据以测定PT抗体的32个实验室中的13个实验室，使用FHA分析的30个实验室中的12个，使用PRN分析的17个实验室中的10个，使用FIM分析的13个实验室中的6个保持了变异系数对于75％的样本，低于20％。测量针对FIM的抗体的测定似乎不如其他测定精确。在使用类似方法的实验室之间，精度各不相同。对于实验室内的给定测定，测定内和测定间变异性的相对值不一致，这表明这些变异性成分的来源可能无关。对于低抗体水平的样品，精密度和一致性似乎不太可靠。排名和回归分析表明，尽管仍然难以支持来自不同实验室的结果的直接比较或组合，但一些实验室仍产生了可比较的定量结果。在某些实验室中，对美国参考百日咳抗血清的校准似乎已成功地标准化了结果。统计分析受测定精度的影响，不一定是定量结果中生物学相关差异的可靠唯一预测因子​​。如果必须比较来自不同实验室的结果，则应进行精确度和定量一致性的适当研究以支持特定的比较。

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