Lesson Learned from Mass Antibody Rapid Diagnostic Used in the Early COVID-19 Pandemic in Indonesia Contributors [Letter]

Triwiyanto, B. Utomo, Sari Lutfiyah, I. Putu, Alit Pawana
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Abstract

We are writing in response to the in-depth findings presented in the article entitled “Lesson Learned from Mass Antibody Rapid Diagnostic Used in the Early COVID-19 Pandemic in Indonesia Contributors” by Indrati et al, 1 published in Medical Devices: Evidence and Research. This study reveals a comprehensive analysis of the performance and characteristics of SARS-CoV-2 antibody rapid diagnostic tests (RDTs) used in the early phase of the COVID-19 outbreak in Indonesia. The authors conducted a comprehensive evaluation of various antibody RDTs, including total, IgG, and IgM, to assess the accuracy of the diagnostic results and their utility in differentiating between past and current infections. Furthermore, a comprehensive examination of sample characteristics, including the diversity in sample status and type, enhances our comprehension of the practical applications of these diagnostic tools in real-world settings. 2 In conclusion, this paper makes a significant contribution to the field by offering valuable findings regarding the effectiveness and challenges associated with using antibody RDTs for the diagnosis of COVID-19. Although this study provides valuable and outstanding findings, it also highlights several weaknesses and limitations that need to be considered. One significant limitation of this study is its retrospective nature, which may introduce bias and limitations in data interpretation. Furthermore, the heterogeneity of the screening process and the relatively small sample size for some brands of antibody RDTs may impact the validity and generalizability of the findings. 3 Furthermore, this study identified common technical issues, such as unclear or invalid results, which underscores the necessity for enhanced standardization and quality control measures in the manufacture and application
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从印度尼西亚 COVID-19 大流行早期使用的大规模抗体快速诊断中汲取的经验教训 [来信] 投稿人
我们撰写这篇文章是为了回应 Indrati 等人发表在《医疗器械》上的题为 "印度尼西亚 COVID-19 大流行早期使用大规模抗体快速诊断的经验教训贡献者 "1 一文中的深入研究结果:证据与研究》上发表。该研究全面分析了印度尼西亚 COVID-19 爆发初期使用的 SARS-CoV-2 抗体快速诊断测试 (RDT) 的性能和特点。作者对包括总抗体、IgG 和 IgM 在内的各种抗体 RDT 进行了全面评估,以评估诊断结果的准确性及其在区分既往感染和当前感染方面的实用性。此外,对样本特征(包括样本状态和类型的多样性)进行的全面检查增强了我们对这些诊断工具在实际环境中的实际应用的理解。2 总之,本文就使用抗体 RDT 诊断 COVID-19 的有效性和相关挑战提供了有价值的发现,为该领域做出了重大贡献。虽然本研究提供了宝贵而杰出的发现,但也凸显了一些需要考虑的弱点和局限性。本研究的一个重要局限是其回顾性,这可能会在数据解释方面带来偏差和局限性。此外,筛查过程的异质性和某些品牌的抗体检测试剂盒样本量相对较小,可能会影响研究结果的有效性和可推广性。3 此外,本研究还发现了一些常见的技术问题,如结果不明确或无效,这突出表明在生产和应用过程中必须加强标准化和质量控制措施。
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