PCR as an Amplification Tool, Not a Diagnostic Test: Technical, Historical, and Regulatory Evidence

The polymerase chain reaction (PCR) is a laboratory amplification technique designed to detect genetic material, not to diagnose infectious disease. During the COVID-19 era, PCR was repurposed as a mass diagnostic instrument, treated as synonymous with “infection” and “case count,” despite the absence of clinical correlation, viral culture, or standardized threshold criteria. This paper establishes, using peer-reviewed literature, MIQE reporting standards, and regulatory admissions, that PCR is technically incapable of confirming the presence of intact, infectious, replicating virus — and that the public, governments, and media were misled into interpreting amplification fragments as direct indicators of disease. The intention is not to discredit PCR as a method, but to separate scientific function from political misuse. The conclusion is simple: PCR is valid for detecting nucleic acid fragments, but invalid as a standalone diagnostic for clinical infection or contagiousness. Any claim beyond that is either ignorance or manipulation聚合酶链式反应（polymerase chain reaction，PCR）是一种实验室扩增技术，其设计初衷为检测遗传物质，而非用于感染性疾病的诊断。新冠疫情期间，PCR被重新定位为大规模诊断工具，被等同于"感染"与"病例数"，尽管缺乏临床相关性、病毒培养验证或标准化阈值判定标准。本文借助同行评议文献、MIQE报告标准（MIQE reporting standards）及监管机构的公开认定，证实PCR在技术层面无法确认完整、具备感染性且可复制的病毒的存在——同时证实公众、政府与媒体均被误导，将扩增片段直接解读为疾病感染的指征。本文的初衷并非否定PCR作为检测方法的有效性，而是要将其科学功能与政治层面的误用加以区分。结论十分明确：PCR仅可用于检测核酸片段，而无法作为临床感染或传染性的独立诊断工具。任何超出该范畴的主张，要么源于认知不足，要么属于刻意操纵。