What is an antigen test kit?

There are two types of antigen test kits: medical antigen test kits and general antigen test kits (OTC). Products that are not intended for diagnostic purposes and are intended for research purposes (hereinafter referred to as "antigen test kits for research") are not subject to handling because their performance, etc. have not been confirmed.

Notes on research antigen test kits for new coronavirus infections (request for publicity) (PDF: 125KB)

What is an antigen test?

This is a test method that detects proteins, which are the components of the new coronavirus (SARS-CoV-2), using virus-specific antibodies. A positive result indicates that virus is present in the specimen.

Medical antigen test kit

Target antigen test kit

Medical antigen test kits approved under the Pharmaceuticals and Medical Devices Act are eligible.

Ministry of Health, Labor and Welfare website "Approval information for in-vitro diagnostic medicines (test kits) for new coronavirus infections" (link to an external site)

Basic Concept of Medical Antigen Test Kits

(1) Not recommended for definitive diagnosis in asymptomatic individuals.

(2) Even if a symptomatic person has a low viral load, the result may be negative even if they are infected. is needed.

(3) Visiting a pharmacy by a person who feels unwell or other symptoms should be avoided from the perspective of infection control, and in such cases it is appropriate to seek medical attention.

(4) Antigen test kits for medical use are handled as pharmacy drugs under the Pharmaceuticals and Medical Devices Law, and the following points must be noted when selling them.

・Pharmacists should provide necessary information and provide guidance based on pharmaceutical knowledge, and should not sell or provide drugs if it is recognized that proper use cannot be ensured.

・Save the number of sales, the date and time, and the results of confirmation that the contents of information provision and guidance have been understood.

Response when selling at a pharmacy

(1) If you have symptoms, in principle, you should consult a medical institution, and if you are concerned about your physical condition at home, etc., it is used as a self-check, and it is necessary to explain the following carefully.

・If you test positive, consult a medical institution.

・Even if it is negative, consider the possibility of a false negative, and if you have symptoms, go to a medical institution. continue infection control measures

(2) In order to fully understand the testing method, etc., it is necessary to explain the following in particular, using Attachment 1 (For those who purchase simple antigen kits at pharmacies) (PDF: 346KB) . .

・Be fully aware of the testing method, etc., and collect the specimen yourself.

・Persons who can collect should understand the implementation method, etc., and should be able to independently collect by themselves.

(3) In order to confirm that the purchaser understands the contents of (1) and (2) above, we will ask the purchaser to sign Attachment 2 (Confirmation) (PDF: 108KB) .

Reference notice

For details of handling, please refer to the reference notice.

Regarding handling of medical antigen test kits at pharmacies under the epidemic of new coronavirus infection (PDF: 346KB)

Handling of administrative inspections related to new coronavirus infections based on "Handling of medical antigen test kits at pharmacies under the epidemic of new coronavirus infections" (PDF: 58KB)

General Antigen Test Kit (OTC)

Target antigen test kit

The products that have been approved as general-purpose antigen test kits (OTC) can be confirmed on the Ministry of Health, Labor and Welfare website below. It can be purchased on the Internet, etc. Look for the “Class 1 OTC drug” label.

Ministry of Health, Labor and Welfare website "Approval status of general antigen test kit (OTC) for new coronavirus infection (link to an external site)

If you search for "corona test kit" etc. at some online shops, many test kits "for research" that are not approved by the Ministry of Health, Labor and Welfare will be displayed, so please be careful not to purchase it by mistake. Please select an approved antigen test kit by referring to product photos, etc. by searching by entering the "item name".

General-use antigen test kits (OTC) are shipped with lot numbers under control from the time of shipment from manufacturers. It is not possible to sell over-the-counter (OTC) drugs that have already been delivered to pharmacies as ethical drugs.

Basic Concept of Antigen Test Kits for General Use (OTC)

(1) Antigen test kits for general use (OTC) are not intended for self-diagnosis of novel coronavirus infections, but for self-checking at home, etc., if you are concerned about your physical condition. It should be used as a reference for selecting appropriate actions, leading to more reliable medical examinations, etc., and to prevent the spread of infection.

(2) Antigen test kits (OTC) may give negative results even if they are infected but have a low viral load. However, it is necessary to continue to take measures to prevent infection.

(3) Visiting the office or store for purchases by people who feel unwell or other symptoms should be avoided from the perspective of infection control.In such cases, purchases by agents or Internet sales, etc. purchases using this service or consideration of visiting a medical institution depending on the symptoms.

(4) Antigen test kits (OTC) are Class 1 drugs under the Pharmaceutical Affairs Law, and when selling them, it is necessary to provide careful explanations and appropriately store records, etc., based on the following matters. to be.

・There is an obligation to provide information in writing by pharmacists.

・If there is a consultation, the pharmacist has an obligation to respond

・It is required to save the results of confirmation that the quantity sold, the date and time, and the content of the information provided have been understood.

How to sell general-purpose antigen test kits (OTC)

Providing information at the time of sale

When selling antigen test kits (OTC), it is necessary to carefully explain the following contents to prospective purchasers and confirm that they have understood the contents before selling them. In addition, it is permissible to provide and sell information by a method (online) that makes it possible to communicate while mutually recognizing the state of the other party by sending and receiving video and audio.

(1) Antigen test kits (OTC) are intended to be used at home, etc., as a self-check when you are concerned about your physical condition. Yes, please carefully explain the following matters.

・Possibility of false negatives

・Cannot be used as negative proof

(2) Appropriately use explanatory materials prepared by the manufacturing/marketing authorization holder, and provide detailed explanations using diagrams, videos, etc., so that the testing method, etc., can be fully understood.

(3) Regarding the determination of the results, carefully explain the following contents in particular so that the user can select an appropriate action after the test.

・In the case of a positive test, registration at a health follow-up center with a doctor (e.g., positive person registration center), consultation at a medical institution for medical treatment/testing, etc. according to

・Even in the case of a negative judgment, considering the possibility of a false negative, even if there are no symptoms, continue to wear a mask when going out and continue to take basic infection control measures such as hand disinfection. If you have any symptoms, follow the guidance of the local government where the user resides for medical examination, etc. In addition, if there is a consultation from a user who has tested positive, follow the guidance of the local government where the user resides, such as providing the necessary contact information, etc. to the user.

(4) When performing specific sales such as internet sales instead of face-to-face sales, instead of only confirming that the customer understands the entire information provided by e-mail, etc., check boxes are provided individually (1)-( 3) Confirm that you have understood each item individually.

(5) At the time of sale, the act of selling or giving all or part of the purchased antigen test kit (OTC) to others (resale) may violate Article 24, Paragraph 1 of the Pharmaceuticals and Medical Devices Law. Respond appropriately, such as by providing information.

Display, Advertisement, Sales, Conveyance and Recording

(1) At the time of sales, etc., displays and advertisements that confuse purchasers with antigen test kits (OTC) and antigen test kits for research among kits that measure the presence or absence of novel coronavirus antigens. and do not sell. The performance of antigen test kits for research use is not guaranteed, and we will refrain from selling them. We have just indicated that we would like to work on it, and we will continue to respond based on that purpose.

(2) Enforcement, etc. of the Act Partially Amending the Pharmaceutical Affairs Act and the Pharmacists Act” (Notification No. 0310-1 of the Pharmaceutical and Food Safety Bureau, Ministry of Health, Labor and Welfare dated March 10, 2014), Transportation is also included in the management duties of pharmacy managers and store managers. be required to be transported; Therefore, proper management of antigen test kits (OTC) must be carried out by issuing necessary instructions to delivery companies, etc.

(3) Article 14, Paragraph 3 of the Ordinance for Enforcement of the Law Concerning Ensuring Quality, Efficacy and Safety of Pharmaceuticals and Medical Devices (Ministry of Health and Welfare Ordinance No. 1 of 1961) when selling Class 1 drugs , Article 146, Paragraph 3 and Article 149-5, Paragraph 3, the product name, quantity, date and time, etc. must be recorded in writing and preserved for two years.

Reference notice

For details of handling, please refer to the reference notice.

Points to note when selling general-use novel coronavirus antigen qualitative test kits under the novel coronavirus epidemic (PDF: 369KB)

Leaflet on proper selection of antigen test kits for new coronavirus infections

Based on the fact that the general-use antigen qualitative test kit for the new coronavirus infection has been approved under the Pharmaceutical Affairs Law and will be manufactured and sold, the leaflet for dissemination has been revised as follows.

We ask that you once again make it known that consumers should choose antigen qualitative test kits for medical use or general use that have been approved based on the Pharmaceuticals and Medical Devices Law, rather than antigen qualitative test kits for research use.

About leaflet about appropriate choice of antigen qualitative test kit of new coronavirus infectious disease (PDF: 213KB)