Accuracy management survey of nucleic acid amplification tests using inactivated SARS-CoV-2 in Hiroshima Prefecture

NOMURA Toshihito

NAZMUL Tanuza

HIGASHIURA Akifumi

SHIGEMOTO Naoki

ARIYOSHI Kunie

KITAGAWA Hiroki

OMORI Keitaro

SHIGEMOTO Norihumi

KUWABARA Masao

KO Ko

TANAKA Junko

TAHARA Hidetoshi

OHDAN Hideki

KUBO Tatsuhiko

OHGE Hiroki

SAKAGUCHI Takemasa

Hiroshima Journal of Medical Sciences

[PISSN] 0018-2052

[EISSN] 2433-7668

[NCID] AA00664312

At the beginning of 2020, the number of laboratories performing SARS-CoV-2 testing increased with the rapid expansion of COVID-19 in Hiroshima Prefecture. Thus, it is necessary to compare and verify the validity of the test results among local laboratories. In this study, we distributed the same standard samples to laboratories that performed COVID-19 testing using the nucleic acid amplification method and confirmed the accuracy of the tests. The SARS-CoV-2 strain distributed by the National Institute of Infectious Diseases (NIID), Japan, was used for testing. As measured by RT-qPCR, a specific amount of the virus was inactivated by ethanol and dried as specimens for distribution. This study included 27 tests performed at 15 laboratories conducting or planning to conduct nucleic acid amplification tests (RT-qPCR and LAMP methods) for SARSCoV-2. The detection limit of each test method was set at the value provided by the NIID. The accuracy of the tests was examined to determine whether they met the required accuracy criteria. SARS-CoV-2 genomic RNA was reliably detected in all 27 tests. The inactivated specimens used in this study were safe to distribute and could be used as positive controls for all methods.

COVID-19

Laboratory Test

RT-qPCR

LAMP

英語

Hiroshima University Medical Press

Copyright (c) 2022 Hiroshima University Medical Press

[ISSN] 0018-2052

[ISSN] 2433-7668

[NCID] AA00664312