【Product Name】High Tester N Pregnancy Test Kit
【Indications and Effects】Detection of human chorionic gonadotropin (hCG) in urine
[Pregnancy Testing]
【Storage Precautions】● Keep out of reach of children.
● Avoid direct sunlight and store in a cool place as much as possible.
● Do not use products past the expiration date.
● Do not open the individual packaging of the test stick until immediately before use.
● To maintain quality, do not transfer to other containers.
【Consumer Consultation Desk】Mizuhomedii Co., Ltd. 【Customer Service Office】
Phone Number: 0120-85-0323
Reception Hours: Monday to Friday (excluding holidays) 9:00-12:00, 13:00-17:00
【Manufacturing and Selling Company】Arinamin Pharmaceutical (formerly: Takeda Consumer Healthcare)
【Usage and Dosage】◆ How to perform the testYou can perform the test about one week after the expected date of your period. You can test with urine collected in the morning, noon, or night.
(1) PreparationOpen the individual package immediately before testing, and take out the test stick.Attach the cap to the opposite side of the test stick.
(2) Applying urineWith the collection part facing downward, pour urine onto the entire collection part for at least 5 seconds.If using a paper cup or similar, collect urine in the cup and immerse the entire collection part in urine for 10 seconds.
(3) Static placementWhile keeping the collection part facing downward, cover with the cap and place on a flat surface, then wait 1-3 minutes.
◆ How to interpret the resultsFirst, confirm that a purple-red end line appears in the result window.
ItemContent
【Positive】 Pregnancy reaction present (a purple-red line appears in the judgment window) There is a possibility of pregnancy.Please seek medical diagnosis as soon as possible.ItemContent
【Negative】 No pregnancy reaction (no purple-red line appears in the judgment window) No pregnancy reaction was detected in this test.If your period does not start afterward, re-test after about one week or consult a doctor.【Precautions for Use】※ Do not pour urine toward the judgment window or side surfaces.※ Do not apply urine to anything other than the collection part.※ Avoid interpreting results after more than 10 minutes.※ Do not re-apply urine to a test stick that has already been used.※ Do not point the collection part upward.
【Components and Quantities】Per test stickMouse monoclonal anti-hCG antibody: 1.0 μgMouse monoclonal anti-hCG antibody conjugated gold colloid: 6.0 μg(Detection sensitivity 50 IU/L)
【Ingredients and Additives】None
◆ Things you should not do● Do not make a definitive diagnosis of pregnancy based solely on the test result.◯ A positive result indicates a possibility of pregnancy, but cannot determine if the pregnancy is normal, so please seek medical diagnosis as soon as possible.◯ A confirmed pregnancy diagnosis is made by a doctor based on medical history, ultrasound, and other comprehensive assessments.
◆ Consult if
1. Those undergoing infertility treatment should consult a doctor before use.
2. Even if the result is negative, if your period does not start afterward, re-test or consult a doctor.◆ Caution regarding timing of testing
3. If your menstrual cycle is regularThis test can be performed about one week after the expected date of your period. However, in early pregnancy, some individuals may have very low levels of urinary hCG, which can result in false negatives or unclear results. If such results occur and about a week passes without your period starting, re-test or consult a doctor.
4. If your menstrual cycle is irregularEstimate the expected date based on your previous cycle and test approximately one week after that date. If the result is negative but your period does not start afterward, re-test or consult a doctor.◆ Disposal precautions● After use, dispose of the test stick as plastic waste according to your local disposal regulations.
◆ Other precautions[Urine collection precautions]● When collecting urine in a cup, use a clean, dry container.● Do not use urine that has been left standing for a long time, is cloudy, or contains foreign objects.[Testing procedure precautions]● Follow the specified procedure correctly.● When attaching the cap to the opposite side of the test stick, do not press too hard. Excessive force may prevent removal.● After applying urine to or on the collection part, do not point the collection part upward, as the result may not be interpretable.[Result interpretation precautions]● During reaction, the entire reaction area may turn purple or show a striped pattern. Do not interpret during this time. It will fade over time. The test line appears as a vertical line.● Insufficient urine volume or improper application may prevent interpretation within 1-3 minutes. If the end line appears within about 10 minutes, interpretation is possible.● The intensity of the test line may vary depending on the amount of hCG in urine. Interpret based on the presence or absence of the line in the judgment window, not on color intensity.● If no purple line (end line) appears in the end window, the result is invalid. Possible user error; repeat the test with a new test stick.● A positive result may occur in cases other than pregnancy, such as:- Menopause- hCG-producing tumors (e.g., trophoblastic tumors)- Use of gonadotropin drugs (certain ovulation inducers containing hCG)● A negative result may occur even if:- Your cycle is irregular- You miscalculate the expected date- Early pregnancy urine hCG levels are too low- hCG is secreted in very high amounts due to pregnancy (rarely occurs more than about 2 months after last period)- Ectopic pregnancy- Fetal abnormalities (fetal death, missed miscarriage)- Excessive hCG secretion due to molar pregnancy- Improper operation or handling of the test