Validation and comprehensive analysis of Streptococcus pneumoniae IgG WHO enzyme-linked immunosorbent assay in an Indian reference laboratory.

IF 1.9 4区医学 Q3 BIOCHEMICAL RESEARCH METHODS

Bioanalysis Pub Date : 2024-02-01 Epub Date: 2024-02-05 DOI:10.4155/bio-2023-0111

Mettingal Ramakrishnan Shincy, Govindan Vandana, Manheri Mavupadi Akhila, Ravindran Shilpa, Kadahalli Lingegowda Ravikumar

引用次数: 0

Abstract

Monitoring serotype-specific IgG levels against pneumococci is crucial for assessing immunity, vaccine efficacy, and evaluating vaccination programs. The WHO ELISA for pneumococci is a standardized assay ensuring consistency in testing and comparability of results across laboratories. It involves a rigorous testing process to confirm accurate, precise and reliable detection of antibodies. We validated the protocol for 13 pneumococcal serotypes by assessing its specificity, reproducibility (coefficient of variation ≤15%), repeatability (coefficient of variation ≤20%), accuracy, lower limit of quantification, stability, and robustness. We found these parameters were within acceptable ranges and showed excellent performance. Our findings imply that the method employed is appropriate for evaluating 13 valent pneumococcal conjugate vaccine which is introduced in the national immunization program by comparing pre-and post-vaccination IgG response.

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印度参考实验室对肺炎链球菌 IgG 世卫组织酶联免疫吸附试验的验证和综合分析。

监测针对肺炎球菌的血清型特异性 IgG 水平对于评估免疫力、疫苗效力和疫苗接种计划至关重要。世卫组织的肺炎球菌酶联免疫吸附试验是一种标准化检测方法，可确保检测的一致性和各实验室检测结果的可比性。它包含一个严格的测试过程，以确认抗体检测的准确性、精确性和可靠性。我们通过评估其特异性、再现性（变异系数≤15%）、重复性（变异系数≤20%）、准确性、定量下限、稳定性和稳健性，对 13 种肺炎球菌血清型的检测方案进行了验证。我们发现这些参数都在可接受的范围内，表现出卓越的性能。我们的研究结果表明，所采用的方法适合于通过比较接种前和接种后的 IgG 反应来评估国家免疫计划中引入的 13 价肺炎球菌结合疫苗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL

CiteScore

3.30

自引率

16.70%

发文量

审稿时长

2 months

期刊介绍： Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.