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New release of “Fuji Dry Chem IMMUNO AG Handy COVID-19 Ag”
New coronavirus antigen test kit that does not require a dedicated test device
Applying high-sensitivity detection technology based on a unique silver salt amplification reaction}
FUJIFILM Corporation (President: Sadaichi Goto) is a new handy type coronavirus (SARS-CoV-2) that does not require a dedicated inspection device and applies high-sensitivity detection technology by the silver salt amplification reaction used in the photo development process. ) FUJIFILM Medical Co., Ltd. uses the antigen test kit “Fuji Dry Chem IMMUNO AG Handy COVID-19 Ag” (hereinafter, “Handy COVID-19 Ag”) as an in vitro diagnostic drug. It will be released from July 27, 2021 through (President: Yoshihiro Kawahara).

With the spread of the new coronavirus infection (COVID-19), in Japan, at elderly facilities and medical institutions where elderly people with a high risk of aggravation enter, promptly use an antigen test kit for mildly ill people. Inspection is in progress. In addition, in order to prevent large-scale clusters and medical strains, universities and companies are also encouraged to actively test using antigen test kits ^{* 1} . In the future, antigen testing, which enables simple and quick testing, is expected to be used in more situations, but its sensitivity is generally lower than that of PCR testing, and higher sensitivity has been desired.

The “Handy COVID-19 Ag” to be released this time is an antigen test kit that can easily and quickly test for the presence of new coronavirus antigens without the need for a dedicated test device and at any test location. After dropping the sample extract onto the cartridge, the test result can be obtained in 10 to 13 minutes with a simple button operation, and the result can be visually confirmed on the spot.

“Handy COVID-19 Ag” uses an antibody developed by Yokohama City University (Yokohama City, Kanagawa Prefecture, hereinafter referred to as Yokohama City University) that can detect the new coronavirus antigen with high accuracy. By combining with the silver amplification immunochromatography method ^{* 2} , it is possible to detect with a small amount of virus. In the performance confirmation of this test kit using cultured viruses and clinical specimens conducted in collaboration with Yokohama City University, it was confirmed that it shows higher virus detection ability than the immunochromatography method that does not use silver amplification ^{* 3} . We also confirmed that virus antigens can be detected in alpha strains ^{* 4} , beta strains ^{* 4} , and gamma strains ^{* 4} , which are mutant strains of the new coronavirus .

Fujifilm is a new coronavirus antigen test kit “Fuji Drychem IMMUNO AG Cartridge COVID-19 A ^* ” for the “IMMUNO AG” series of infectious disease testing devices, which was introduced in March this year at more than 25,000 clinics nationwide. ⁵ ”has been released, providing medical institutions with a convenient testing environment for the new coronavirus. By launching “Handy COVID-19 Ag” this time, it will be possible to test the new coronavirus even in facilities for the elderly, companies, schools, etc. that do not have a testing device, contributing to further expansion of the testing system and suppression of the spread of infection. To do.

New Coronavirus Antigen Test Kit “Fuji Dry Chem IMMUNO AG Handy COVID-19 Ag”

FUJIFILM will continue to contribute to improving the efficiency of examinations and the quality of medical care by providing a wide range of products and services that meet the needs of medical practice.

* 1 Decided by the government’s new coronavirus infectious disease countermeasures headquarters “Basic countermeasures for new coronavirus infectious disease countermeasures (changed on May 28, 3rd year of Reiwa)”
* 2 In the immunochromatography method, when a test substance (virus, etc.) is present in a sample (nasopharyngeal swab, etc.) dropped into a reagent, it binds to the labeled antibody in the reagent to generate an antigen-antibody complex. A test method in which a colored line indicating positive (with antigen) is displayed when the complex is captured by an antibody that is linearly applied on the detection line in advance. Since the results can be obtained easily and quickly, it is often used for testing for infectious diseases that require urgent treatment.
* 3 Yamaoka et al., Highly specific monoclonal antibodies and epitope identification against SARS-CoV-2 nucleocapsid protein for antigen detection tests, Cell Reports Medicine (2021), https://doi.org/10.1016/j.xcrm.2021.100311
* 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)
* 5 Approval number: 30300EZX00024000

Silver amplification technology applied to the antigen test kit to be released this time

When the gold (Au) colloid, the reducing agent, and the silver ion coexist, the silver ion reacts with the reducing agent only around the gold colloid, and metallic silver (Ag) is likely to be generated (silver amplification reaction).

The test kit released this time applies this principle. The capture antibody applied to the detection line catches the antigen bound to the antibody labeled with gold colloid (step ①), and by controlling the silver amplification reaction described above, metallic silver is generated only where the gold colloid label is present. , Form a large metallic silver (step ②).

As a result, the visual detection ability is greatly improved.

References: T. Broger, B. Sossen, et al., Lancet Infect. Dis. 2019; 19 852–61.

Record
1. Product name
SARS Coronavirus Antigen Test Kit
(Brand name: Fuji Drychem IMMUNO AG Handy COVID-19 Ag, Approval number: 30300EZX00015000)

2. Main features
(1) High sensitivity is achieved by applying high-sensitivity detection technology by silver salt amplification reaction.
When the amount of virus is small by using the development technology of photographic film to amplify the label, which is a marker of the antigen, about 100 times compared to the case where the technology is not used, and to improve the visibility and sensitivity. But it can be detected.

(2) Uses an antibody that can detect the new coronavirus (SARS-CoV2) antigen developed by Yokohama City University with high accuracy.
It distinguishes from conventional coronavirus and influenza virus and detects new coronavirus antigens with high accuracy. We also confirmed that virus antigens can be detected with high accuracy even for mutant strains such as alpha strains, beta strains, and gamma strains because we use antibodies that target viral antigen sites that are not easily affected by mutations.

(3) Inspection results can be confirmed on the spot without the need for a dedicated inspection device and regardless of the inspection location.
No equipment such as a reactor or reader is required, and it can be inspected anywhere. With a simple button operation, rapid antigen test measurement by silver amplification immunochromatography is possible, and the test result can be visually confirmed.

(4) Rapid inspection with a measurement time of 10 to 13 minutes is possible.
After collecting the sample with the attached cotton swab and dropping the sample extract into the kit, the test result can be obtained in 10 to 13 minutes.

3. Main specifications

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