How to Use (Directions for Use) *Note: This is a medical product. Please read the instructions carefully regarding usage and dosage (precautions related to usage and dosage).*

Before conducting the test, prepare a clock or timer.

If stored in the refrigerator, bring the test components to room temperature (15–30°C) about 30 minutes prior to testing.

● How to perform the test

＜Preparation for the test＞

1. Twist and snap off the tab of the extraction liquid ampoule. Since there is a possibility of the liquid splashing out, hold the ampoule at the bottom (not the liquid reservoir part), with the spout facing upward, and twist to break.

2. Hold the extraction liquid ampoule vertically and add 300 μL of extraction liquid to the upper limit line (300 μL) of the specimen extraction container. Do not滴全部滴下. Excessive or insufficient extraction liquid may lead to inaccurate results.

3. Place the specimen extraction container with the extracted liquid into the stand.

＜Self-collection of specimen (nasal swab)＞

Remove the sterile swab from the package without touching the cotton part.

1. Gently insert the sterile swab about 2 cm into the nostril, as shown in the diagram.

2. Along the inner wall of the nose, rotate the swab 5 times.

3. Carefully remove the swab and repeat the specimen collection in the other nostril using the same swab. Confirm that the swab is sufficiently moist after collection.

＜Sample preparation＞

After collecting the specimen, proceed with sample preparation promptly.

1. Immerse the cotton part of the swab into the extraction liquid, pressing against the wall of the tube, and rotate at least 5 times.

2. Then, squeeze out the specimen from the cotton part of the swab by pressing it with your fingers from outside the specimen container.

3. Break the shaft of the swab at the break point.

4. Securely close the cap of the specimen extraction container and place it into the stand.

＜Dropping the sample＞

1. Take the test device out of the aluminum pouch and place it on a flat surface.

2. Open the cap of the滴下 nozzle of the specimen extraction container and滴5 drops of the specimen液 vertically onto the specimen addition part of the test device. Do not move the test device until the reaction is complete. Foam inside the extraction container may cause inaccurate results.

If the appropriate amount of液 cannot be滴, the nozzle may be clogged. Lightly shake the extraction container to clear the clog.

3. After use, close the滴下 nozzle cap of the specimen extraction container and dispose of it.

4. After 15 minutes, check for the presence or absence of lines. Do not use test devices that have been left for more than 20 minutes after the reaction for judgment.

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Ingredients / Raw Materials (Nutritional Components / Allergens)

＜Kit Contents and Components / Quantities＞

(Contents) Single-use test kit, 1 test

(Components) During 1 test

1. Test device ........................................ 1 piece

Anti-SARS-CoV-2 monoclonal antibody (mouse)

Gold colloid particles conjugated with anti-SARS-CoV-2 human monoclonal antibody

2. Extraction liquid .................................. 1 bottle

Accessories

- Specimen extraction container ............ 1 bottle

- Cap for specimen extraction container .... 1 piece

- Sterile swab ........................................ 1 piece

- Stand for specimen extraction container ... 1 piece

- Simple operation guide .......................... 1 sheet

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Precautions for Use, Storage, and Handling

- This test kit is a in vitro diagnostic medical device (over-the-counter drug) approved by the Ministry of Health, Labour and Welfare as a general-use test reagent. Please read the "Precautions for Use" carefully and use it as directed. If the test result is "positive," seek appropriate medical attention. Even if the result is "negative," if symptoms are present, seek medical attention appropriately.

- When performing the test, pay attention to the following:

(Regarding specimen collection)

- Always use a clean swab (included in the kit).

- After collection, immediately place the specimen into the provided extraction container and perform the test promptly.

- Different collection methods or sites may lead to incorrect results.

- For nasal swab collection, proper specimen collection is essential for accurate results. Carefully read ＜Self-collection of nasal swab＞ and use enough specimen from both nostrils with one sterile swab.

- Do not touch the tip of the sterile swab with your hands before use.

- Do not use if the swab is broken, bent, or dirty. Do not reuse the swab.

- The included sterile swab is only for nasal swab collection. Use only for nasal specimen collection.

(Regarding test procedure)

- The extraction solution contains a preservative (sodium azide). If the solution or sample contacts skin, eyes, or mouth, rinse thoroughly with water. Seek medical attention if necessary.

- Do not eat, drink, or smoke in areas handling specimens or reagents.

- Do not disassemble or modify the product.

- Do not open the aluminum pouch until the temperature has returned to 15–30°C.

- Do not use if the aluminum pouch is damaged or not sealed.

- When滴 dropping the specimen液 onto the test device, hold the extraction container vertically to ensure proper滴量.

- Follow the specified滴量; deviations may cause inaccurate results.

- Do not wet the test device with nasal液 or other liquids.

(Regarding interpretation of results)

- Do not interpret the results after the specified static time, as they may change. Always judge within the specified time.

- If the result is unclear or difficult to interpret, seek medical attention as if the result were positive.

- Any visible line should be considered positive regardless of its intensity.

- Infection with severe acute respiratory syndrome coronavirus (SARS-CoV) may cause a positive result with this product (cross-reactivity).

- Substances present in the specimen or added to the nasal cavity do not affect the result (no interference substances or drugs).

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Contact Information

Taisho Pharmaceutical Co., Ltd.

TEL: 03-3985-1800

Hours: 8:30–17:00 (excluding Saturdays, Sundays, and holidays)

Manufacturer / Distributor (Official Name)

Abbott Diagnostics Medical Co., Ltd.

Address: 357 Matsudai, Matsudo-shi, Chiba Prefecture

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*Note: Packaging design and other details are subject to change without notice. Please understand.*