Panbio Covid-19 Antigen Rapid Test (General Use) Single Use Taisho Pharmaceutical [Class 1 Drug]

Detection of SARS-CoV-2 antigen in nasal swab fluid

[Shape, structure, etc. (kit composition)]
1. Test device: 1 piece
Anti-SARS-CoV-2 mouse monoclonal antibody
Anti-SARS-CoV-2 human monoclonal antibody-conjugated gold colloid particles
2. Extract liquid: 1 bottle
(accessories)
・Sample extraction container: 1 bottle
・Sample extraction container cap: 1 piece
・Sterile cotton swab: 1
・Sample extraction container stand: 1 piece
・Simple operation guide: 1 sheet

(1) Twist and thread off the tab of the extract ampoule.
Caution: When twisting and threading off the tab on the extract ampoule, the extract may spill out, so hold the bottom of the ampoule, not the liquid pool, and cut with the spout facing up.
(2) Hold the extract ampoule vertically and add the extract up to the upper limit line of the sample extraction container.
Caution: Do not drop the entire amount. If you extract too much or not enough, you may not get proper results.
(3) Place the sample extraction container containing the extraction solution on the sample extraction container stand.

(1) Remove the sterile cotton swab from the bag without touching the tip (cotton ball part).
(2) Gently insert a sterile cotton swab approximately 2 cm into the nostril. Roll the sterile cotton swab five times along the inside wall of your nose.
(3) Slowly remove the sterile cotton swab and repeat the sample collection from the other nostril using the same cotton swab. Make sure the swab is sufficiently moist after specimen collection.

Please prepare the sample immediately after collecting the sample.
(1) Dip the swab part of the cotton swab after collecting the sample into the extract solution, and rotate it at least 5 times while pressing it against the tube wall.
(2) Then, squeeze the sample from the outside of the sample extraction container while pressing the cotton ball with your fingers.
(3) Break the cotton swab shaft at the break point.
(4) Tightly tighten the sample extraction container cap and place it on the sample extraction container stand.
Note: Be sure to close the cap firmly.

(1) Remove the test device from the aluminum bag and place it on a flat surface.
(2) Open the cap of the dripping nozzle of the sample extraction container and drop 5 drops of the sample solution vertically into the sample addition section of the test device.
CAUTION: Do not move the test device until the reaction has finished. Foam formation within the sample extraction container can lead to inaccurate results. If the appropriate amount of liquid cannot be dripped, the nozzle may be clogged, so shake the sample extraction container gently to remove the clog.
(3) Close the drip nozzle cap of the used sample extraction container before disposing of it.
(4) Observe the judgment area of ​​the test device after 15 minutes and judge whether there is a line or not. Do not use the test device for judgment after more than 20 minutes have passed since the reaction.

(Precautions regarding sample collection)
・Please be sure to use a clean cotton swab (kit accessory).
— Immediately after collecting the sample, place it in the attached sample extraction container and perform the test immediately.
— Correct results may not be obtained if the sampling method or site is different.
・When collecting nasal swabs, correct results may not be obtained if the specimen is not collected properly, so please read carefully and use a sufficient amount of specimen collected from both nostrils with one sterile cotton swab.
・Do not touch the tip of the sterile cotton swab directly with your hands before use.
— Do not use the sterile cotton swab if it is broken, bent, or dirty. Do not reuse cotton swabs.
— The included sterile cotton swab is for collecting nasal swab fluid. Please use only to collect nasal swab fluid.
(Note regarding inspection procedures)
・The extract contains a preservative (sodium azide). If the solution or sample comes into contact with your skin or accidentally enters your eyes or mouth when operating the kit, rinse thoroughly with water. Please seek medical attention if necessary.
— Do not eat, drink, or smoke in areas where samples and reagents are handled.
・Do not disassemble this product and use it.
・Do not open the aluminum bag until the temperature returns to 15 to 30 degrees.
・Do not use damaged or unsealed aluminum bags.
・When dropping the sample liquid onto the test device, please place the sample extraction container vertically to obtain the appropriate amount of liquid to drip.
・Please keep the specified amount when dropping the sample. If the amount other than the specified amount is used, appropriate results may not be obtained.
— Do not wet the test device with nasal swabs or other liquids.
(Note regarding judgment)
— If the specified standing time has passed, the results displayed on the test device may change, so be sure to make a judgment within the specified time.
・If the result displayed on the test device is not clear and it is difficult to judge, please visit a medical institution as appropriate, just as you would if the test result was positive.
— If a line is observed, please indicate that there is a line regardless of its shade.
・If you have been infected with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV), you may receive a positive result with this product (cross-reaction).
・As a result of evaluating the substances that may be present in the sample or added to the nasal cavity, there was no effect on the results (interfering substances/interfering drugs).

Consultation on how to receive a medical examination If you would like to receive a medical examination based on the results, please first consult with your family doctor or other nearby medical institution in your area by telephone, etc.
*To prevent nosocomial infections, please refrain from visiting a medical institution directly without contacting us, except in cases of emergency.
If you are unsure of where to consult, such as because you do not have a family doctor, please consult the «Consultation and Consultation Center» (name may vary depending on region).

(1) Please keep out of reach of children.
(2) Avoid direct sunlight, high temperature and humidity, store this product at 2 to 30 degrees, and do not freeze.
(3) To maintain quality, please do not transfer to another container.
(4) Do not reuse the test device.
(5) Please open the package immediately before use.
(6) Do not use products whose expiration date has passed.
(7) Do not touch the sample addition section and judgment area of ​​the test device directly with your hands.

Taisho Pharmaceutical Co., Ltd. Customer Room 119
3-24-1 Takada, Toshima-ku, Tokyo 170-8633
03-3985-1800