國際間對新型冠狀病毒抗原檢驗試劑之管理要求比較

Comparison of International Regulatory Requirements for SARS-CoV-2 Antigen Tests

迄2024年6月止，全球新型冠狀病毒（SARS-CoV-2）確診案例已達7億7千5百萬餘，並造成近7百萬死亡案例，即使已有相關疫苗，惟新型冠狀病毒變異株帶有更強的免疫逃脫特性，因此安全可靠的檢測對於控制COVID-19疫情發揮著關鍵作用。目前核酸檢驗為確認個案是否感染SARS-CoV-2的黃金標準，抗原檢驗試劑通常用於初步篩檢使用。相較於核酸檢驗，抗原檢驗試劑具快速、易操作及低成本等優勢，然而其靈敏度較差，易有偽陰性的情況發生。
回顧現有文獻，多數集中於疫情期間新型冠狀病毒抗原檢驗試劑的臨床使用情況，或僅針對少數國家進行某項性能評估項目的比較，缺乏對新型冠狀病毒抗原檢驗試劑的多國多區域管理規定的全面分析。本篇文章比較臺灣、美國、歐盟、中國和韓國對SARS-CoV-2抗原檢驗試劑的上市前審查要求，包括分析反應性、偵測極限、分析特異性-交叉反應性、分析特異性-干擾、閾值、精密度／再現性與方法比較等，各國對此類產品的性能評估要求或有不同程度的差異，然而其目的及管理方向相似。此外，有鑑於SARS-CoV-2具高度傳染性及變異性，變異株的突變位點可能影響檢驗試劑之準確度，如何確保市面上經核准的新型冠狀病毒檢驗試劑產品保持安全及有效，是各國衛生主管機關面臨的一大課題。

As of June 2024, there have been over 775 million confirmed cases of COVID-19 globally, resulting in nearly 7 million deaths. Even with available vaccines, new variants of the coronavirus exhibit stronger immune escape characteristics, making safe and reliable testing crucial for controlling the COVID-19 pandemic. Currently, nucleic acid tests are the gold standard for confirming SARS-CoV-2 infection, while antigen tests are typically used for preliminary screening. Compared to nucleic acid tests, antigen tests offer advantages such as speed, ease of use, and low cost. However, they are less sensitive and more prone to false negatives.
Existing literature has primarily focused on investigating the clinical use of SARS-CoV-2 antigen tests during the pandemic, or comparing specific performance evaluation requirements across a limited number of countries or regions. This article provides a comprehensive review and discussion of the regulatory requirements for SARS-CoV-2 antigen tests in countries with representative medical device management practices. Specifically, it compares the pre-market review requirements for SARS-CoV-2 antigen tests in Taiwan, the United States, the European Union, China, and South Korea. The comparison includes analytical reactivity, detection limits, analytical specificity (cross-reactivity and interference), cut-off, precision/reproducibility, and method comparison. While the performance evaluation requirements for these products may vary to some extent among countries, their objectives and directions are similar. Additionally, given the high transmissibility and variability of SARS-CoV-2, mutations in variant strains may affect the accuracy of test kits. Ensuring that approved COVID-19 test products on the market remain safe and effective is a major challenge for health authorities worldwide.