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The Journal of the Japanese Society for Clinical Microbiology |
Biblioraphy Information
| ArticleTitle |
Quality control of a nucleic acid amplification tests for pathogens -Focusing on SARS-CoV-2- |
| Language |
J |
| AuthorList |
Kotaro Aoki, Yoshikazu Ishii |
| Affiliation |
Department of Microbiology and Infectious Diseases, Toho University School of Medicine |
| Publication |
J.J.C.M.: 32 (2), 85-93, 2022 |
| Received |
December 28, 2021 |
| Accepted |
|
| Abstract |
The pneumonia pathogen of unknown cause that emerged in Wuhan, China, was whole-genome sequenced by next-generation sequencing analysis and released to the public in January 2020. The pathogen is called the novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and based on the whole-genome sequence information, a nucleic acid amplification tests (NAATs) represented by reverse-transcription TaqMan real-time PCR (PCR test) was rapidly constructed. Currently, the PCR test is widely used as NAATs for pathogens related to the coronavirus disease 2019 around the world. Although a number of SARS-CoV-2 PCR tests have been developed and used, their performance is not homogeneous. Laboratory developed tests, which are constructed using arbitrary combinations of reagents, shall be validated for their performance. Among the pre-test, test, and post-test processes, many PCR tests are kits for the test process only, and even research use only reagents or in vitro diagnostics need to be validated when combined with any nucleic acid extraction method. In order to ensure the quality of testing, it is important for laboratories to detect and correct problems as early as possible through daily internal quality assesment, and to proactively participate in external quality assesment program in an effort to improve the level of testing ant their own facilities. |
| Keywords |
SARS-CoV-2, PCR, RT-qPCR |
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