Top > Research use only products (RUO) > QuaResearch COVID-19 Antigen Detection Kit RUO 1test
Detection of antigens against the novel coronavirus
This detection kit uses immunochromatographic method to detect the antigen against novel coronavirus.
This product is a detection kit that provides test results in approximately 15 minutes by simple sample processing without the need for special measuring equipment.
Intended use
For investigation and research on the novel coronavirus antigens.
*This product is not an in-vitro diagnostic product. It cannot be used for preventive, diagnostic or therapeutic purposes.
※ Be sure to read the instruction manual and video before use.
Instruction manual
Features
・Made in Japan
・No measuring equipment required
・Measurement time is only 15 minutes.
Main Specifications
Measurement method: Immunochromatographic method
Measurement time: 15 minutes
Storage method: 2℃~28℃
Validity Period: 24 months from the date of manufacture
Kit Contents
1. Test stick *1
2. Sample buffer *1
3. Nozzle
4. Swab *1
5. Sampling sheet *1
.
Test protocol
Measuring principle
This assay is based on immunochromatographic technology using monoclonal antibodies against SARS-CoV-2 antigen. The test stick consists of a sample well, a conjugate pad containing colored nanoparticle-labeled anti-SARS-CoV-2 monoclonal antibody (rabbit) (hereinafter, the colored nanoparticle-antibody), a membrane immobilized with anti-SARS-CoV-2 monoclonal antibody (mouse) (hereinafter, a capture antibody) and an anti-rabbit immunoglobulin polyclonal antibody (goat).
Overall View of the Test Stick
Sample dropped on the sample well of the test stick will flow into the conjugate pad due to the capillary phenomenon. The colored nanoparticles-labeled antibody in the conjugate pad will dissolve in the specimen and form the antigen-antibody complex with the SARS-CoV-2 antigen in the sample. The formed antigen-antibody complex continuously move to the membrane and is captured with the capture antibody immobilized on the membrane. The colored nanoparticles of the captured antigen-antibody complex will appear as a red line on the [T1] in the test window. In this kit, appearance of this red line can be visually confirmed to determine the presence of SARS-CoV-2 antigen in the specimen. In addition, the non-complexed antibody conjugated with red nanoparticles will move to the [C] in the test window and be captured with polyclonal antibody against rabbit immunoglobulin immobilized on the membrane. The colored nanoparticles of the captured non-complexed antibody will appear as a red line on the [C] in the test window, indicating that the test is performing successfully.
Measuring Principles
Flow Direction
Significance of measurement
The disease caused by the novel coronavirus SARS-CoV-2 was first identified in Wuhan City, Hubei Province, People's Republic of China in 12, 2019, and the WHO declared it a pandemic in March 2020. SARS-CoV-2 antigens are detected with high sensitivity using PCR, mainly using nasopharyngeal swabs as samples. On the other hand, antigen detection methods are not as sensitive as PCR methods, but because they target viral antigen proteins, they are easier to handle compared to nucleic acid samples for PCR, and immunochemical methods can be used more easily and quickly. Although detailed knowledge of the site and timing of sampling is not yet sufficient between PCR and antigen detection, various attempts are being made to apply antigen detection methods worldwide.
Other precautions
This product is not an in-vitro diagnostic product. It cannot be used for preventive, diagnostic or therapeutic purposes.
This product is intended for use in surveys and research.
We apologize for the inconvenience, but this product is an item for research purposes, and we do not accept orders from individuals who do not belong to local governments, companies, corporations, organizations, medical institutions, administrative agencies, or research institutions. We appreciate your understanding in order to avoid using this product for purposes other than those intended.
<Precautions when purchasing research products>
• This product is a research product. Please read the instruction manual and operation video before purchasing, and be aware that there is a risk that the correct operation may not be achieved depending on the user's technique.
• The detection performance when nasal blow fluid is used as a sample is currently in the research stage, and its performance cannot necessarily be guaranteed. Please be aware of this before using.
• We cannot guarantee any malfunction during sampling due to incorrect operation.
• Due to individual differences in handling the sampling sheet and swab, we cannot guarantee that nasal fluid will be collected smoothly in all cases.
• The specifications of the detection kit are based on the test conditions in the instruction manual and academic information, and we do not guarantee the same performance in all cases.
<Other Notes>
• This product is not an in-vitro diagnostic product. It cannot be used for preventive, diagnostic or therapeutic purposes.
• Please be sure to read the instruction manual before use.
• Please check the latest version of the protocol posted on the web before operating.
• This product is intended for use in research (surveys, learning, scientific research, educational awareness). Please use at your own risk.
• Store in a place away from direct sunlight between 2 and 28ºC.
• Please keep out of reach of children when using.
• The user is responsible for taking measures to prevent infection.
• Use the included sampling equipment. When using other sampling devices, the user should verify and determine whether the desired observation value can be obtained.
• When collecting and handling a sample of nasal or nasopharyngeal swab, be sure to check the requirements in accordance with laws and guidelines and be properly performed by a medical professionals. Our company assumes no responsibility for any event that occurs during this operation.
• The disposal of this product, its buffer and any by-products should always be in accordance with the requirements of the Law on Environmental Protection and Waste Disposal and with the requirements of the local authorities. Dispose of the product after use according to the instructions of your municipality.
We will continue to make effort to ensure that our products are properly used as research products. Thank you in advance for your understanding and cooperation with related companies and users.
Related publication
-
Jacqueline Dinnes et al.
Rapid, point-of-care antigen and molecular-based tests for diagnosis of SARS-CoV-2 infection
Cochrane Database Syst Rev. 2021 Mar. PubMed PMID: 33760236
-
Marco Ciotti et al.
Performance of a rapid antigen test in the diagnosis of SARS‐CoV‐2 infection
J Med Virol. 2021 Feb. PubMed PMID: 33527409
-
Bo Diao et al.
Accuracy of a nucleocapsid protein antigen rapid test in the diagnosis of SARS-CoV-2 infection
Clin Microbiol Infect. 2021 Feb. PubMed PMID: 33031947
References
1.) The Coronavirus Disease 2019 (COVID-19) Pathogen Detection Manual, ver2.9.1. National Institute of Infectious Diseases, Japan
2.) Guidelines for the operation of assay for the novel coronavirus (SARS-CoV-2), 3rd edition, National Institute of Infectious Diseases, Japan
3.) Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19). WHO Kobe Center published in Japanese
4.) WHO Website : : “Naming the coronavirus disease (COVID‐19) and the virus that causes it (https://www.who.int/emergencies/diseases/novelcoronavirus- 2019/technical-guidance/naming-thecoronavirus- disease-(covid-2019)-and-the-virus-that-causes-it)
5.) Guidelines for testing for novel coronavirus (COVID-19) pathogens, 1st edition, issued on October 2, 2020, MHLW, Japan