[About the new coronavirus antigen qualitative test kit (first-class drugs)]
The "medical" new coronavirus antigen qualitative test kit, which could only be purchased at pharmacies, can now be purchased at drugstores and the Internet as an over-the-counter test drug (over-the-counter in-vitro diagnostic drug) for Class 1 drugs. rice field.
We will introduce interesting information such as the difference from "medical use" and precautions for use.
What is an antigen (qualitative) test kit for class 1 drugs?
With the novel coronavirus raging, from the perspective of reducing the burden on medical institutions conducting testing and ensuring testing opportunities for many people, OTC (antigen test kits) for "medical use" antigen qualitative test kits (hereinafter referred to as antigen test kits) marketed as a Class 1 OTC drug) has been approved by the Ministry of Health, Labor and Welfare. (Approved on August 24, 2022) With this approval, antigen test kits other than "research use" can now be purchased at familiar drugstores and on the Internet.
Antigen test kits for class 1 drugs can be purchased after receiving information from a pharmacist, just like the "medical" antigen test kits sold at pharmacies .
It is now possible to self-check at home when you are concerned about your physical condition.
What class 1 drug antigen (qualitative) test kits can and cannot do
◎ What you can do
Assistance in judgment of suspected new coronavirus infection
Class 1 drug antigen test kits are not intended for diagnostic purposes .
It will be used only as a self-check tool.
×What you can't do
① Positive diagnosis
Even if you use an antigen test kit and get a "positive" judgment, it will not be a positive diagnosis .
A positive diagnosis can only be made by a doctor. If you test yourself and get a positive result, please consult a medical institution.
In addition, depending on the local government, there are places where a doctor will make a positive diagnosis by applying with a photo of the test kit that you have carried out yourself. For details, please check the website of each local government.
② Negative proof
Negative proof is issued by testing institutions such as medical institutions (as of August 24, 2022) , and the antigen test kit itself cannot be used as negative proof .
*Negative certificates will only be issued based on judgments made with “medical” antigen test kits. If you need a negative proof, please consult a testing institution such as a medical institution.
*Since there is no fixed format for the content and period of negative proof, it is also necessary to confirm with each submission destination what items are required.
In such cases, consult a medical institution, etc.
・When tested with a class 1 drug antigen test kit, a “positive” result was obtained.
Since you may be infected with the new coronavirus, please consult a medical institution or consult with the follow-up center of each local government.
* Even if the test result is positive, it may be a false positive (a "positive" result even if you are not infected). Please consult with a medical institution, etc. to determine this.
・Symptoms such as fever, cough, and sore throat were tested with a class 1 drug antigen test kit, and the result was "negative".
Even if the test result is negative, consider the possibility of a false negative (a "negative" result even if you are infected), and if you have symptoms, immediately consult a medical institution or consult a local government Please consult with the follow-up center, etc.
In addition, we have summarized information that you are interested in, such as questions about antigen test kits. Please refer to it.
♦♦ Antigen test kit Q&A
