■ Product OverviewManufacturer: Arax Co., Ltd.Product Name: Check One Fast (1 Test)Pharmaceutical Classification: In Vitro Diagnostic Medical DeviceCategory: Prescription-Free Medical DevicePediatric Classification: For Adults Only (Dosage and administration are for adults aged 15 and over)Drug Form: OtherContents: 1 TestProduct Overview: This is a medical device that is not a prescription drug.Please confirm the following precautions before selling.
[Handling of Medical Devices Other Than Prescription Drugs]- Quantity Limitation- Storage and Dispensing in Pharmacy- Creation of Sales Records- Implementation of Medical Record Management- Face-to-Face Sales by Pharmacist in Pharmacy
[Other Precautions]- Prohibition of Advertising- Implementation of Medication Guidance- Attachment of Package Insert, etc.
For details, click [here].[Expiration Date]More than 8 months remaining until expiration from the time of shipment.JAN Code: 4987009184732Product Code: 101401925
■ Features- High sensitivity of 25 mIU/mL, allowing testing from the expected date of menstruation.- Easy to use: simply apply urine to the absorbent tip.- Results can be determined in 1 minute.- Easy to interpret the results based on the presence or absence of a red line in the result display area.
■ General Precautions- This kit is an in vitro diagnostic medical device and should not be used for any other purpose.- This kit is intended for the detection of hCG in urine only. For definitive diagnosis, consult a specialist's clinical findings.- We do not guarantee performance for uses other than those described in the electronic package insert.
■ Intended UseDetection of human chorionic gonadotropin (hCG) in urine.
■ Measurement Principle1. Measurement PrincipleCheck One Fast is a kit that detects human chorionic gonadotropin (hCG) in urine using a gold colloid immunochromatographic assay.If hCG is present in the urine, it forms a complex with the gold colloid-labeled anti-hCG-β monoclonal antibody and moves up the test stick by capillary action. This complex is captured by the anti-hCG-α monoclonal antibody immobilized in the result display area, causing a red line to appear. Excess gold colloid-labeled anti-hCG-β monoclonal antibody moves further up and is captured by the immobilized anti-mouse IgG polyclonal antibody, causing a red line to appear in the control line area. If hCG is not present in the urine, only a red line will appear in the control line area.
■ Operational Precautions1. Properties and Collection Method of Measurement Sample- Use fresh urine samples for the specimen.- Do not use urine that is heavily contaminated with blood, pus, or other foreign matter.- If collecting urine in a container, use a dry, clean container and test the urine promptly after collection.2. Interfering SubstancesWhen substances that may interfere with the reaction were added to negative urine and negative urine with 25 mIU/mL of hCG added, the following substances did not affect the results at the indicated concentrations:Acetaminophen 200 μg/mL, Acetone 10 mg/mL, Acetylsalicylic acid 200 μg/mL, Albumin 20 mg/mL, Ampicillin 40 μg/mL, Ascorbic acid 2 mg/mL, Ascorbate 4 mg/mL, Atropine 200 μg/mL, Biotin 250 ng/mL, Caffeine anhydrous 200 μg/mL, Caffeine hydrate 200 μg/mL, Ethenzamide 200 μg/mL, Clomiphene citrate 10 μg/mL, Creatinine 2 mg/mL, Ethanol 7.9 mg/mL, Gentisic acid 200 μg/mL, Glucose 90 mg/mL, Hydroxybutyric acid 1 mg/mL, Ibuprofen 2 mg/mL, Oxalic acid 600 μg/mL, Riboflavin 20 μg/mL, Salicylic acid 200 μg/mL, Sodium carbonate 2500 μg/mL, Sodium chloride 10 mg/mL, Uric acid 100 μg/mL, Urea 5 mg/mL, Cortisol 200 ng/mL, DHEAS 9000 ng/mL, Estrone 25 ng/mL, Estradiol 25 ng/mL, Estriol 25 ng/mL, Progesterone 40 ng/mL, Estriol-3-glucuronide 1 μg/mL, Estriol-3-sulfate 1 μg/mL, Estrone-3-glucuronide 1 μg/mL, Estrone-3-sulfate 1 μg/mL, Cannabidiol 100 μg/mL, Phenothiazine 20 μg/mL, Solazine 20 μg/mL, Hemoglobin 5 mg/mL, Bilirubin 20 μg/mL
3. Cross-ReactivityNo cross-reactivity was observed with hLH (up to 300 mIU/mL), hFSH (up to 1000 mIU/mL), or hTSH (up to 1 mIU/mL) with this kit.
■ Dosage and Administration1. Preparation of ReagentUse the test stick as is.2. Required Instruments, Equipment, Samples, etc.- Timer or clock- Urine collection container (dry and clean: if urine is not applied directly to the absorbent tip)3. Measurement (Operation) Method(1) Apply urine to the tip of the test stick for 2 seconds, or collect the specimen (urine) in a container and immerse the tip of the test stick in the urine for 2 seconds.(1) Let stand for 1 minute for reaction, then interpret the results.
■ Interpretation of Measurement ResultsAfter confirming that a red line has appeared in the control line area of the test stick, interpret the results based on the presence or absence of a red line in the result display area.Positive:Consider the result positive if a red line appears in the result display area, even if faint.Negative:Consider the result negative if no red line appears in the result display area.
Re-test:If no red line appears in the control line area, it is likely due to improper operation. Please re-test with another test stick.
This diagnostic agent is used as an auxiliary reagent for pregnancy diagnosis. For definitive diagnosis of pregnancy, make a comprehensive judgment in conjunction with other clinical findings.
■ Performance- SensitivityWhen testing with a sample of 0 mIU/mL hCG concentration, the result is negative. When testing with a sample of known concentration of 25 mIU/mL hCG concentration, the result is positive.- AccuracyWhen testing with negative urine and negative urine with 25 mIU/mL hCG added, negative urine shows a negative reaction, and negative urine with 25 mIU/mL hCG added shows a positive reaction.- Concurrent ReproducibilityIn the sensitivity test, when the same sample is tested concurrently three times, all test results are identical.- Measurement RangeThe minimum detection sensitivity of this kit is 25 mIU/mL.2. Correlation Study ResultsA correlation study was conducted with a control product having the same sensitivity as this kit, and good correlation was observed as follows:Concordance rate with Control Product A: 97.4% (112/115)Concordance rate with Control Product B: 97.4% (112/115)
3. Information on Calibrator Standard MaterialJapanese Pharmacopoeia Human Chorionic Gonadotropin Standard
■ Precautions for Use and Handling1. Precautions for Handling (Accident Prevention)- When handling specimens, treat them as potentially infectious and take sufficient precautions, such as wearing disposable gloves, considering safety.2. Precautions for Use- This kit is a qualitative reagent for detecting hCG in urine and should not be used for quantitative purposes.- Keep out of reach of children.- Do not disassemble this kit.- Do not expose this kit to direct sunlight or heat.- Store this kit at room temperature and use it before the expiration date indicated on the outer box.- Do not use test sticks that have passed their expiration date.- Do not open the aluminum pouch until ready for use.- Follow the [Dosage and Administration (Operation Method)] for the operating procedure.3. Precautions for Disposal- Dispose of used test sticks in accordance with waste disposal regulations.4. Diagnostic Precautions- Testing can be performed from the expected date of menstruation. If the test result is negative and menstruation does not occur thereafter, re-test one week later.- If the specimen is very diluted, the hCG concentration may be low, resulting in a negative result. If pregnancy is suspected, re-test using first morning urine.- In cases of menopause, postpartum, post-miscarriage, post-induced abortion, hCG-producing tumors, hCG administration, severe diabetes, proteinuria, hematuria, etc., a positive reaction may occur. Also, in cases of ectopic pregnancy or other abnormal pregnancies, hydatidiform mole where hCG secretion is abnormally elevated, or when urinary hCG levels are insufficient in early pregnancy, a negative result may occur. Therefore, pregnancy diagnosis should be made comprehensively in conjunction with other clinical findings.
■ Storage Conditions and Shelf LifeStorage Conditions: Store at room temperature.Shelf Life: 24 months (Expiration date is indicated on the outer box).
■ Packaging Units1 box for 1 test1 box for 2 tests
■ Contact InformationFor inquiries regarding Check One Fast testing and requests for literature:Arax Check One Consultation Room TEL 052 (951) 25033-2-26 Marunouchi, Naka-ku, Nagoya, 460-0002Reception Hours: 9:00 - 16:30 (Closed Saturdays, Sundays, and public holidays)
■ Manufacturer and DistributorArax Co., Ltd.
■ URL of the Product Web Pagehttps://www.arax.co.jp/seihin/iyaku.html
■ Suggested Retail Price1100 yen
■ Pharmaceutical ClassificationIn Vitro Diagnostic Medical Device
■ Disclaimer[Please Note]- The product descriptions posted above, excluding price information, are provided by the manufacturer or the Self-Medication Database Center.- If you have any questions or concerns regarding the use of pharmaceuticals, please consult your doctor or pharmacist.- We assume no responsibility for any health damage caused by the use of pharmaceuticals purchased through this service.