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首页> 外文期刊>Clinical and diagnostic laboratory immunology >Multilaboratory Evaluation of a Viability Assay for Measurement of Opsonophagocytic Antibodies Specific to the Capsular Polysaccharides of Streptococcus pneumoniae
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Multilaboratory Evaluation of a Viability Assay for Measurement of Opsonophagocytic Antibodies Specific to the Capsular Polysaccharides of Streptococcus pneumoniae

机译：多实验室评价的可行性测定，用于测定肺炎链球菌荚膜多糖特异的调理吞噬抗体

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Opsonophagocytosis is a correlate of protection that measures the functional activity of vaccine-induced antibodies. A standardized opsonophagocytosis assay (OPA) should be used as part of the evaluation of current and future pneumococcal (Pnc) polysaccharide (Ps)-based vaccines. We enrolled five laboratories to evaluate a previously standardized viability OPA. Each laboratory was provided with a detailed OPA protocol, seven target Pnc strains (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F), two quality control sera and 12 paired sera (blinded) from adult donors who received one dose of the 23-valent Pnc Ps vaccine. Laboratories sent their results to the Centers for Disease Control and Prevention for analysis. Sera were tested in duplicate (single run), and the results were averaged to yield a single OPA titer (≥50% killing) for each serum sample. The percentage of sera within one or two dilutions of the calculated median OPA titer was determined for each laboratory and for each serotype. In general, laboratories were capable of detecting OPA titers within one or two dilutions of the median for at least 75 and 88%, respectively, of the sera tested. The level of agreement with the median OPA titers varied depending on the participating laboratory (overall agreement = 0.8 [99% confidence interval = 0.75 to 0.85]). All OPA median titers reported for quality control sera were within one dilution of the expected titer. We conclude that this OPA can be done in multiple laboratories with a high degree of interlaboratory reproducibility.
机译：调理吞噬作用是保护的相关因素，可测量疫苗诱导的抗体的功能活性。在评估当前和将来的肺炎球菌（Pnc）多糖（Ps）疫苗时，应使用标准化的调理吞噬细胞试验（OPA）。我们招募了五个实验室来评估以前标准化的可行性OPA。每个实验室都提供了详细的OPA方案，七种目标Pnc菌株（血清型4、6B，9V，14、18C，19F和23F），两个质量控制血清和来自成年供者的一对配对血清（盲）（接受一剂） 23价Pnc Ps疫苗。实验室将其结果发送给疾病预防控制中心进行分析。对血清进行一式两份测试（单次运行），并将结果平均以得出每个血清样品的单次OPA滴度（≥50％杀死率）。确定每个实验室和每种血清型在计算出的中值OPA滴度的一两次稀释中的血清百分比。通常，实验室能够分别在中值的一种或两种稀释液中检测到至少75％和88％的血清中的OPA滴度。与OPA滴度中位数一致的水平随参与实验室的不同而不同（总体一致= 0.8 [99％置信区间= 0.75至0.85]）。报告的质量控制血清的所有OPA中值滴度均在预期滴度的一个稀释度之内。我们得出的结论是，该OPA可以在多个实验室中以高度的实验室间再现性进行。

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