It was announced on 13 May 2020 that Fujirebio had developed a testing kit that can measure seropositivity in 30 minutes and will be used alongside PCR testing. The use of the kits would be controlled to healthcare centres, as the Ministry of Health, Labour and Welfare announced today.[1] In practice, it would be used by medical institutions that suspect an individual of being positive or a hospitals where a cluster has emerged, but not for decision-making on patients being discharged from care or who are not symptomatic.
The name of the product is iAMP COVID-19 Detection kit, which was developed with Atila Biosystems, a California based company since 2009 specializing in biochemical engineering for developing diagnostic clinical tools, and most significantly developed the 3N technology.[2] On 12 May, Fujirebio Europe announced that the product has been CE marked to show the manufacturer checked the product against EU safety, health and environmental legislations.[3] On 10 April, the US FDA also granted Emergency Use Authorisation for certain high-complexity laboratories.[4]
[1] ANNnewsCH, 「抗原検査キットで厚労省が指針 PCR検査と併用を (20/05/13)」. 13 May 2020. <https://youtu.be/JjSxGf0yGYY>. [2] Atila Biosystems, ‘3N Technology’, 2020. <https://atilabiosystems.com/our-technologies/>. [3] Fujirebio, ‘iAMP® COVID-19 Detection kit, a molecular SARS-CoV-2 detection assay distributed by Fujirebio Europe, is now CE marked’, 12 May 2020. <https://www.fujirebio.com/en/news-events/iampr-covid19-detection-kit-a-molecular-sarscov2-detection-assay-distributed-by>. UK Government, ‘Guidance: CE marking’, 8 October 2012. <https://www.gov.uk/guidance/ce-marking>. [4] Atila Biosystems, ‘iAMP-COVID-19-100 Instructions for Use’, March 2020. <https://www.fda.gov/media/136870/download> and <https://atilabiosystems.com/our-products/covid-19/>.