HCG Digital Pregnancy Test

Intended use

HCG Digital Pregnancy Test is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine at 25 mIU/mL or above. HCG Digital Pregnancy Test is intended for use as an aid in early detection of pregnancy. It is not automated. It is for self-testing use and only for use outside the body.

Introduction

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both serum and urine as early as 7 to 10 days after conception1-4. hCG level continues to rise very rapidly, frequently exceeding 100 mIU/ml (in urine) by the first missed menstrual period2-4, and peaking in the 30,000~100,000 mIU/ml (in urine) range by 10-12 weeks into pregnancy.

The appearance of hCG in urine soon after conception and its rapid rise in concentration makes it an ideal marker for the early detection and confirmation of pregnancy. However, elevated hCG levels are frequently associated with trophoblastic and non-trophoblastic neoplasm and hence these conditions should be considered before a diagnosis of pregnancy can be made.

Precautions

1. Single-use test. Do not reuse.
2. Do not touch the Absorbent Wick to avoid contamination.
3. Avoid cross-contamination of specimens by using a new specimen collection container for each specimen obtained.

4. Urine specimens may be potentially infectious, and should be handled observing usual safety precautions.

5. Do not interchange or mix reagents or components from different lots.

Test Procedure

Test device, pre-collected urine sample, and controls should be brought to room temperature (15-30°C) prior to testing. Do not open pouches until ready to perform the assay.

Step1. Read the package insert carefully before performing test.

Step2. Remove the test device from the sealed pouch and check the screen for the presence of a steady sand clock symbol. Do Not use the test unless the steady clock symbol is on the screen. Use the device within 10 min.

Step3. Remove the lid.

Questions & Answers

Q: How does the test work?

A: The HCG Digital Pregnancy Test detects the hormone your body produces during

pregnancy, hCG, or human chorionic gonadotropin.

Q: How accurate is the test?

A: In laboratory studies of the Digital Pregnancy Test Midstream with urine samples from pregnant and non-pregnant women, the accuracy was greater than 99% accurate.

Q: What do I do if the result on the Display Screen is "YES+" ?

A: A"YES+" test result shows that the pregnancy hormone (hCG) was detected, which normally indicates pregnancy. You must see your doctor to confirm that you are pregnant.

Q:What do I do if the result on the Display Screen is "NO-"？

A: You may not be pregnant or it may be too early to tell. If you do not get your period within 7 days, you should retest with another Digital Pregnancy Test Midstream. It is possible that you miscalculated the length of your cycle or your urine may not have had enough pregnancy hormone for the test to register a "YES+"result. If upon retesting you get another "NO-" result and your period has still not started, you should call your doctor.

Q: The blinking clock has disappeared followed by a "" on the Display Screen. What does this mean?

A: A "" symbol indicates an error has occurred during testing.You should retest with another Digital Pregnancy Test, carefully following all directions.

Q: How long will my result show on the Display Screen?

A: Your result will be displayed for at least 30 minutes. Read your results within this time frame. Once you have read your result, discard the stick.

Note: This device contains a battery with a removal feature on the reverse side of the Thumb Grip. Be sure to dispose of the battery according to local regulations.

Q: The Display Screen is blank. What is wrong?

A: If the Display Screen is blank before using the test or after using the test but before yielding a result, an error has occurred during testing. You should retest with another Digital Pregnancy Test, carefully following all directions.

Q: What will happen if the plastic holder gets wet?

A: Some splashing while using the test will not damage the test, but if it becomes very wet it can become damaged. If the test becomes damaged, the Display Screen will either go blank or an error ""message will appear.

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