The requirements of nucleic acid test for COVID-19 during public health emergency - Current regulatory in Taiwan, Singapore, and the United States - Review Article

Sep 29, 2026

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By mid-2022, COVID-19 case numbers approached 562 million, yet infection rates remain difficult to confirm. Even with effective vaccines, breakthrough infections from new variants occur, making safe, reliable nucleic-acid testing critical for isolation and outbreak control. This review compares EUA requirements for SARS-CoV-2 nucleic-acid diagnostic tests in Taiwan, Singapore, and the United States, focusing on key performance evaluations. Similarities are observed across countries, with differences in cross-reactivity microorganisms and clinical-evaluation specimen requirements.

LanguageEnglish

CategoryResearch & Report

FormatPDF

Pages6

Reading Time15 min

AccessFree to download

Overview of Coronavirus and Coronavirus Disease-2019 Test

Requirements comparison of nucleic acid tests (EUA)

Performance evaluation items (extraction, inclusivity, LoD, cross-reactivity, interference, cutoff, stability)

Specimen needs for clinical evaluation and exemptions

J Chin MedAssoc Review ARticle The requirements of nucleic acid test for COVID-19 during public health emergency: Current regulatory in Taiwan, Singapore, and the United States Yin-Ting Fana, Jin-Yu Leeb, Yu-Che Chengb, Hsin-Hui Linb, Chia-Hung Chienb, Pei-Weng Tub, Hui-Wen Chunga,* aOffice of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute, Hsinchu, Taiwan, ROC; bDivision of Medical Devices and Cosmetics, Food and Drug Administration, Ministry of Health and Welfare, Taipei, Taiwan, ROC. Abstract In mid-2022, the COVID-19 cases have reached close to 562 million, but its overall infection rate is hard to confirm. Even with effective vaccines, break-through infections with new variants occur, and safe and reliable testing still plays a critical role in isolation of infected individuals and in control of an outbreak of a COVID-19 pandemic. In response to this urgent need, the diagnostic tests for COVID-19 are rapidly evolving and improving these days. The health authorities of many countries issued requirements for detecting SARS-CoV-2 diagnosis tests during the pandemic and have timely access to these tests to ensure safety and effectiveness. In this study, we compared the requirements of EUA in Taiwan, Singapore, and the United States. For the performance evaluations of nucleic acid extraction, inclusivity, limit of detection (LoD), cross-reactivity, interference, cutoff, and stability, the requirements are similar in the three countries. The use of natural clinical specimens is needed for clinical evaluation in Taiwan and the United States. However, carry-over and cross-contamination studies can be exempted in Taiwan and the United States but are required in Singapore. This review outlines requirements and insight to guide the test developers on the development of IVDs. Considering the rapidly evolving viruses and severe pandemic of COVID-19, timely and accurate diagnostic testing is imperative to the management of diseases. As noted above, the performance requirements for SARS-CoV-2 nucleic acid tests are similar between Taiwan, Singapore and the United States. The differences are mainly in two points: the recommended microorganisms for cross-reactivity study, and the specimen requirement for clinical evaluation. This study provides an overview of current requirements of SARS-CoV-2 nucleic acid tests in Taiwan, Singapore, and the United States. Keywords: COVID-19; Emergency use approval (EUA); Nucleic acid tests; Regulation; SARS-CoV-2 1. OVERVIEW OF CORONAVIRUS AND CORONAVIRUS DISEASE-2019 TEST The coronavirus is a single-stranded, positive-sense RNA virus, which belongs to the Coronaviridae family. The crown-shaped virus is 80 to 160 nm in size with its RNA genome size ranges between 27 and 32 K bp characteristically.1,2 The viral envelope contains four major structural proteins: spike glycoprotein (S), * Address correspondence. Dr. Hui-Wen Chung, Office of Medical Device Evaluation, Center for Measurement Standards, Industrial Technology Research Institute, 321, Section 2, Kuang-Fu Road, Hsinchu 300, Taiwan, ROC. [E-mail address: huiwen@itri.org.tw](E-mail address: huiwen@itri.org.tw) (H.-W. Chung). Conflicts of interest: The authors declare that they have no conflicts of interest related to the subject matter or materials discussed in this article. Journal of Chinese Medical Association. (2022) 85: 1038-1043. Received January 27, 2022; accepted July 25, 2022. doi: 10. 1097/JCMA.0000000000000804. Copyright © 2022, the Chinese Medical Association. This is an open access article under the CC BY-NC-ND license ([http://creativecommons.org/licenses/](http://creativecommons.org/licenses/)[ ](http://creativecommons.org/licenses/)[by-nc-nd/4.0/](by-nc-nd/4.0/)) membrane glycoprotein (M), and envelope small membrane protein (E), and the nucleocapsid phosphoprotein (N) that assists with viral RNA packaging. Due to transcription errors and RNA

FAQs

Which countries are compared for EUA requirements for SARS-CoV-2 nucleic acid tests?

The review compares requirements for Taiwan, Singapore, and the United States.

What performance evaluation aspects are used to compare nucleic acid test requirements?

The study compares nucleic acid extraction performance, inclusivity, limit of detection (LoD), cross-reactivity, interference, cutoff, and stability.

What are the main differences among the countries’ requirements?

The differences mainly involve the recommended microorganisms for cross-reactivity study and the specimen requirement for clinical evaluation.

Sep 29, 2026

Upload by Jacob