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Pregnancy Tests

Pregnancy Tests ~ A Brief Overview ~ One Step HCG Urine Pregnancy Tests are used for qualitative (visual) determination of hCG (Human Chorionic Gonadotropin) in urine specimens for early detection of pregnancy. HCG is a glycoprotein hormone secreted by developing placenta shortly after implantation. hCG can be detected in urine and serum of pregnant women as early as 6 to 15 days after conception. The early pregnancy tests are designed to screen very low hCG concentrations in this initial hCG development stage. These tests are specifically designed  for determination of early pregnancy. Tests detect hCG in urine in a qualitative format with sensitivity of 20mIU/mL (International Standard Value). The test line is responsive in the range of 10-50 mIU producing a line directly proportional to concentration of hCG in urine. The specificity is 99.9% meaning that test is highly selective for beta-hCG glycoprotein. Tests have an expiry date of 2 years and can be stored in a dry environment ranging from 2 to 30 degrees Celsius.  The product performance has earned an international reputation for quality and reliability, and are distributed in over 70 countries worldwide.

INTENDED USE

The pregnancy tests are used to obtain quick visual, qualitative results for early detection of pregnancy hCG (human Chorionic Gonadotropin) hormone in urine samples.

INTRODUCTION

Human Chorionic Gonadotropin (hCG) is a glycoprotein hormone secreted by the developing placenta shortly after egg fertilization during pregnancy. hCG can be detected in the urine (also blood and serum) of a patient as early as 6 to 15 days after conception. The intended use of these tests is to screen for early beta hCG development which occurs between 5-50 mIU/mL. The hCG is released by the pituitary gland and and peaks at 100,000-200,000 mIU/mL the end of the first trimester.

SPECIMEN COLLECTION

1.       Obtain a clean plastic or glass container to collect a urine sample.

2.       Even though any urine sample is appropriate for hCG testing, the first morning urine is optimal because it generally contains the highest concentration of hCG in specimen.

3.       Specimen should be allowed to settle for 5 minutes and reach room temperature before testing.

TEST PROCEDURE

1.       Make sure the urine sample and unopened pregnancy test are at room temperature prior to administering the test.

2.       Remove the test device from its protective pouch by tearing along a side notch.

PRODUCT FORMATS AND SAMPLE APPLICATION

The pregnancy tests are available in different formats for easy and convenient testing. The format applications range from professional to home usage. All three tests are identical in functionality and performance, however some users may have personal preferences toward any of the formats.

Pregnancy Test Strip Application
Hold the blue plastic handle and immerse the test strip into the urine with the white absorbent arrow end pointing towards the sample. Make sure not to immerse past the maximum line marker. Take the strip out after 3 seconds and place it horizontally on a clean, dry, surface. Do not immerse for longer than 5 seconds. Allow 5 minutes to complete the test reaction.
Pregnancy Test Cassette Application
Use the plastic pipette provided in the test pouch to withdraw the urine sample. Position the pipette over the round well opening and displace 4 drops (0.2mL) of urine by gently squeezing the pipette. Allow 5 minutes to complete the test reaction.
Pregnancy Test Midstream Application
Remove the plastic cap to expose the absorbent window. Point the absorbent tip (with 5 small openings) directly in urine stream for at least 7-10 seconds to allow the sample into the testing device. (Another technique is to collect urine into a clean container and dip half of the absorbent pad for at least 10 seconds.) Re-cap the device and place it horizontally on a clean, flat surface. Allow 5 minutes to complete the test reaction.

RESULT INTERPRETATION

Make sure to read test results at 5-minute mark. Reading too early or too late may yield incorrect interpretation of the results and may vary according to users experience.

Negative Result: Not Pregnant
Only one colour band appears on the top Control (C) region. There should be no apparent band on the Test (T) region. The control line is designed to validate the test and should be crisp and clear in intensity with white membrane background.

Positive Results: Possible Pregnancy
Distinct and consistent colour bands appear on the Control (C) and Test (T) regions. Colour intensity of the bands may vary according to concentration and level of hCG development. The test line is usually slightly weaker in intensity in comparison to the control line. The pattern of increasing intensity of the test line is a much better predictor of pregnancy rather than any individual reading. Positive test results should always be confirmed with your physician.

Invalid Results
Uncertain test results should be discarded in case there is no visible control line. Repeat test with a new test device.

TEST LIMITATIONS

1.       The urine pregnancy test is designed for in vitro diagnostic use only.

2.       a. Elevated levels of hCG may be produced in rare conditions other than pregnancy (such as trophoblastic disease and certain nontrophoblastic neoplasms).

b. A normal pregnancy cannot be distinguished from an ectopic pregnancy based on hCG levels alone.

c. A spontaneous miscarriage may cause confusion in interpreting the test results.

d. Test results may vary between different individuals.

If you obtain unexpected or inconsistent results please consult with your physician.

3.       As with all pre screening devices, a definitive diagnosis should not be based on the results of a single test, and should always be confirmed with a qualified specialist.

STORAGE AND STABILITY

The test devices should be kept from prolonged exposure to direct sunlight, moisture, heat, and other related conditions.
The test kit can be stored at normal room temperature (2°C to 30°C) in the sealed pouch up to the expiration date of 2 years, which is indicated on the package.

DISPOSAL

Urine samples and used test devices are potentially infectious so please keep them away for direct contact with objects. Proper handling, hands washing, and immediate disposal is recommended.

Q: What is hCG?

A: hCG is human chorionic gonadotropin. It is a hormone produced by the placenta during pregnancy. Home pregnancy tests (HPTs) are designed to detect it.

Q: Why does the hCG level of the test matter?

A: Basically the pregnancy tests that the detect the lowest number of units should give you the earliest results.

Q: How do home pregnancy tests work?

A: Home pregnancy tests (HPTs) are designed to detect hCG, a hormone released by the placenta right after the embryo begins implanting into the uterine lining. The hormone is released in a pregnant woman's urine.

Q: How soon after ovulation can I test?

A: You may be able to get a positive HPT about 10 days after ovulation. If you have not had an hCG injection (common in infertility treatment, brands include Profasi and Pregnyl), you believe the positive, but you might get a false negative. If your period is late, test again. Your hCG levels should double every 2-3 days and many people won't have a positive HPT until the first day of a missed period or even a few days later.

Q: How do I perform the test?

A: You should use midstream urine -- meaning you should pee a little first and then either hold the test stick in your urine stream or use a collection cup. If you would like to collect urine in a cup even though you bought a stick test, you need to hold the absorbant tip of the stick in the cup of urine for 10-15 seconds. Otherwise, follow the directions with the test.

Q: How long do I need to hold my urine?

A: That depends how long after ovulation you are testing. If you are testing early, a four-hour wait is a good idea. The more hCG you have in your system, the less long you'll need to hold before trying to test.

Q: Can I use an HPT if I got an hCG shot (such as Profasi or Pregnyl)?

A: You can, but you should wait 7-14 days after your last injection before the shot is out of your system. If you test too soon, you might get a false positive. Wait 14 days after a 10,000 IU injection, 10 days after a 5,000 IU injection, or 7 days after a 2,500 IU injection.

Q: What should my hCG level be?

A: An rounded-off average would be about 25 mIU at 10 dpo, 50 at 12 dpo, 100 at 14 dpo.

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