Fujifilm New Coronavirus Antigen Quantitative Test Reagent

Immunoanalyzer “Accuraseed” that enables rapid measurement®” exclusive
New Coronavirus Antigen Quantitative Test Reagent
“Acura Seed SARS‐CoV‐2 Antigen”(In‐vitro diagnostic drug)

Fujifilm Wako Junyaku Co., Ltd. (Headquarters: Chuo‐ku, Osaka City, President: Kazuo Shiraki) has developed a new type of coronavirus (accuraseed) as a dedicated reagent for the automatic chemiluminescent enzyme immunoassay device Accuraseed, which enables rapid measurement. SARS‐CoV‐2) In‐vitro diagnostic drug “Accuraseed SARS‐CoV‐2 antigen” that quantitatively measures antigen* 1Will be on sale today.

Nucleic acid detection test (real‐time RT‐PCR (hereinafter referred to as PCR), etc.) is used as a test method for new coronavirus infection (COVID‐19).* 2 And antigen test (qualitative, quantitative). At the moment, the most reliable test is the PCR test* 3Next, other nucleic acid detection tests and antigen quantitative tests are considered to be practical tests, and it is possible to make a definitive diagnosis not only for symptomatic persons but also for asymptomatic persons. Antigen quantitative tests are characterized by a shorter judgment time than PCR tests, and are used in airport quarantine in addition to medical institutions.

The antigen quantitative test reagent “Accuraseed SARS‐CoV‐2 Antigen” to be released this time uses an antibody developed by Yokohama City University (Yokohama City, Kanagawa Prefecture) as a result of joint research with the university. It was obtained. Alpha strain, which is a mutant strain of the new coronavirus, is used with this reagent.※Four, Beta stock※Four, Gamma strain※Four, Delta stock※Four We have confirmed that we can detect the virus antigen.

Accuraseed, an automatic chemiluminescent enzyme immunoassay used in combination with this reagent, is an immunoassay based on the chemiluminescent enzyme immunoassay that combines an antigen‐antibody reaction and a chemiluminescent reaction. It can measure more than 30 items such as thyroid diseases and infectious diseases, and has achieved rapid measurement with a measurement time of about 10 minutes. Since its launch in November 2015, it has responded to the need for rapid diagnosis in clinical practice. With the launch of the “Acura Seed SARS‐CoV‐2 Antigen”, the lineup of reagents exclusively for “Accuraseed ®” will be expanded.

The Fujifilm Group sells “Accuraseed COVID‐19 Antibodies” (research reagents), an antibody measurement reagent that checks for the presence or absence of antibodies against the virus, from Fujifilm Wako Pure Chemical Industries, Ltd. for testing for new coronavirus infections. In addition, the fully automatic gene analyzer Mutasuwako g1※Five Reagent for PCR test “Mutaswako SARS‐ CoV‐2″* 6 Is approved as an in‐vitro diagnostic drug. In addition, FUJIFILM is an infectious disease testing device IMMUNO AG series.* 7Antigen qualitative test kit for “Fuji Dry Chem IMMUNO AG Cartridge COVID‐19 Ag* 8, And “Fuji Dry Chem IMMUNO AG Handy COVID‐19 Ag* 9Is on sale. With the launch of the antigen quantitative test reagent “Acuraseed SARS‐CoV‐2 Antigen”, the test methods for new coronavirus infectious diseases provided by the Fujifilm Group will be further enhanced, and it will be possible to respond to various requests. increase.

We develop and provide high‐performance, high‐quality products that meet the needs of society and customers based on the philosophy of “becoming the power of the next science and creating the source of people’s happiness,” which is the basis of our corporate activities. However, we will contribute to the development of industrial and academic research in a wide range of fields, including medical treatment.

* 1 Approval number 30300EZX00093000
* 2 The PCR (polymerase chain reaction) method that specifically amplifies viral genes (nucleic acids) is used. Whether the gene is present in the sample
There are simple methods such as real‐time RT‐PCR that quantitatively confirms the results, and the LAMP method and TMA method that can determine the results easily and in a short time. * 3 High reliability because the number of virus copies can be compared and the transition can be estimated.
* 4 Alpha strain (UK, B.1.1.7 strain variant), Beta strain (South Africa, B.1.351 strain variant), Gamma strain (Brazil, P.1 strain variant) Strain), Delta strain (India, mutant strain of B.1.617.2 strain)
* 5 Medical device notification number 27B3X00024000016
* 6 Approval number 30300EZX00094000
* 7 Medical device notification number 14B1X10022000123 (brand name: Fuji Dry Chem IMMUNO AG2) * 8 Approval number 30300EZX00024000
* 9 Approval number 30300EZX00015000

Main features of inspection with this reagent

Type of inspection
Measurement time
processing power
Measurement target

“Acura Seed SARS‐CoV‐2 Antigen” to be released this time

The reagents of the “Acura Seed” series are monotest methods in which the reagents required for one measurement are enclosed in one cartridge in pursuit of ease of use. A cassette containing 20 cartridges is set in the device, and one cartridge is automatically opened for each measurement. The part where the cassette is set is a cold storage, and even after setting it in the device, each cartridge is stored in the optimum environment until the time of measurement.

Automatic chemiluminescent enzyme immunoassay Accuraseed

Approval number 30300EZX00093000

A large number of samples can be processed at the same time, and all test items can be measured quickly in about 10 minutes.

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