In-vitro diagnostics (IVD)
Top > In-vitro diagnostics (IVD) > Quampas COVID-19 Antigen Test Kit (General Use)
This kit detects the antigen of the novel coronavirus and was approved as the class 1 OTC drug by the Ministry of Health, Labour and Welfare.
About using this kit
Use this kit as a self-check if you are feeling unwell, and if you test positive, seek medical attention appropriately. Even if your test result is negative, please consider the possibility of a false negative and seek medical attention if you have symptoms. Even if you have no symptoms, please continue to take basic infection control measures such as wearing a mask and disinfecting your hands when going out.
※If your local government has issued guidance on how to go to a medical institution, please follow the instructions and go to a medical institution appropriately.
※Please refer to the latest information issued by the Ministry of Health, Labour and Welfare for how to utilize the information in case of close contact.
How to use
Please be sure to check the package insert before using. Consult your doctor or pharmacist if you have any questions about the contents of the package insert.
Package insert
flyer
※ Be sure to read the instruction manual and video before use.
※ Move to the official distributor page
Intended use
Detection of SARS-CoV-2 antigen in nasal swabs (to aid in the diagnosis of SARS-CoV-2 infection.)
Kit Contents
1. Test Stick *1
(Components related to reaction )
Anti-SARS-CoV-2 antibody (mouse monoclonal antibody)
Colored nanoparticle labeled antibody SARS-CoV-2 antibody (rabbit monoclonal antibody)
2. Sample buffer *1
<Accessories>
Swab (sterile cotton swab) *1
Nozzle (with filter) *1
・
Test protocol
Prohibited Matters
You cannot make your own diagnosis based on the test results (please follow "About using this kit" above).
About Consulting
Consult your doctor or pharmacist if you find anything difficult to understand in this manual.
Notes on Disposal
Dispose of this kit and used swabs as household waste according to the disposal method of each local government. Used cotton swabs, etc. may be infectious and therefore, be careful when disposing of them. Place the used kit (including swabs, tubes, etc.) in the garbage bag and seal it tightly. If the bag is torn, place it into another garbage bag to prevent scattering.
Regarding consultation on medical examinations
Please consult the results with a local medical institution such as your family doctor by telephone.
※ To prevent nosocomial infection, please refrain from visiting the medical institution without contacting except in case of emergency.
If you are unsure of whom to consult, for example, if you do not have a family doctor, please consult with the "Consultation Center" (name may vary by regions). There is a guide about the medical institutions available nearby and how to see a doctor. The following URL summarizes information on consultation and medical care and contact information of consultation centers published by each prefecture.
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/covid19-kikokusyasessyokusya.html
Main Specifications
Product name: Quampas ®︎ COVID-19 Antigen Test Kit (General Use)
Product number: IQVALF011G
Measurement method: Immunochromatographic method
Measurement time: 15 minutes
Sample: Nasal swab
Storage method: 1℃~30℃
Q&A
Q. How should I store the kit?
A. Store the kit in a cool, dark place at 1 ~ 30 °C. Also, keep it out of the reach of children.
Q. If I keep it in the refrigerator, can I use it immediately after taking it out?
A. If this kit has been refrigerated, take it out of the refrigerator and leave it for at least 30 minutes to return to
15-30℃ before use.
Q. The sample buffer cannot be dropped even if it is pinched from the outside of the vial.
A. There may be a case where the lump of the sample is stuck to the nozzle. Shake lightly to remove the clog from the nozzle and then drop again.
Q. I added the reagent, but I cannot see it flowing into the test window.
A. The amount of sample processing solution may be insufficient. Immediately add 1-2 drops of sample buffer. Within 1 minute, the sheet begins to get wet and the line on the "C" can be seen. When dropping sample buffer, make sure that the droplet is securely placed on the sample dropping part.
Q. Can I move the test stick during the reaction for 15 minutes after dropping the sample buffer?
A. Avoid moving the test stick during the reaction as this may affect deployment. Keep it on a flat surface
during the reaction.
Q. A line appeared on the test window [C] after more than 15 minutes. Is there any problem?
A. Any result after more than 15 minutes is invalid.
Q. The line on the test window [T1] is very thin, uneven in density, or broken.
A. If the line on the test window [C] can be visually confirmed, it is judged as positive even if the line of [T1] is thin, uneven, or broken.
Q. The result was positive. What should I do.
A. A. Please consult the results with a local medical institution such as your family doctor by telephone.
※ To prevent nosocomial infection, please refrain from visiting the medical institution without contacting except in case of emergency.
If you are unsure of whom to consult, please consult with the "Consultation Center" (name may vary by regions). There is a guide about the medical institutions available nearby and how to see a doctor. The following URL summarizes information on consultation and medical care and contact information of consultation centers published by each prefecture.
→formation on consultation services by prefectures regarding the novel coronavirus
Q. The result was negative. What should I do?
A. Even if your test result is negative, please consider the possibility of a false negative and seek medical attention if you have symptoms. Even if you have no symptoms, please continue to take basic infection control measures such as wearing a mask and disinfecting your hands when going out.
