Pregnancy Test Instructions

PREGNANCY TEST DESCRIPTION

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 pregnancy tests are specifically designed for professional users (doctors, clinics, family planning centres) for determination of early pregnancy, but have also found a place in home pregnancy testing applications due to ease of use and low cost. 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.

Early home pregnancy tests have an expiry date of 2 years and can be stored in a dry environment ranging from 2 to 30 degrees Celsius. The products are manufactured in ISO 9001 facility and posses Health Canada, US FDA 510k, and European CE certificates. These pregnancy test products have earned an international reputation for quality and reliability, and are distributed in over 70 countries worldwide.

PREGNANCY TEST FORMATS
The early pregnancy tests are available in 3 different formats:

1. PREGNANCY TEST STRIP
2. PREGNANCY TEST CASSETTE
3. PREGNANCY TEST MIDSTREAM

The pregnancy test kits are specialized formats optimized for applications such as  professional or home pregnancy testing. For more information about each format please visit PREGNANCY TEST OVERVIEW page.

STEP 1 - PREGNANCY TEST PROCEDURE

Bring the pregnancy test pouch to room temperature (18-30°C). Collect urine into a clean container (such as plastic cup). The best way to collect sample is by placing a cup in the middle of urination process. To begin testing, open the sealed pouch by tearing along the notch. Remove the pregnancy test from the pouch when you are ready to use it.

STEP 2 - TEST FORMAT SAMPLE APPLICATION

PREGNANCY TEST STRIP - Immerse the strip into the urine with the arrow end pointing towards the urine. Do not immerse past the MAX (maximum) line. Take the pregnancy test out after 3 seconds and lay the strip flat on a clean, dry, non-absorbent surface (e.g., mouth of the urine container). Do not immerse the strip in urine for longer than 5 seconds.

PREGNANCY TEST CASSETTE - Draw the urine sample into the sterilized pipette (provided in pouch), and dispense 0.2ml (about 4 drops) into the round dropping well of the pregnancy test cassette.

PREGNANCY TEST MIDSTREAM - Hold the round end of the purple cap cover with one hand. Use the other hand to pull out the pregnancy test midstream to expose the absorbent intake window. Point the absorbent tip downward and place the absorbent tip in urine stream for at least 10 seconds to be thoroughly wetted. Otherwise, you can collect your urine into a clean cup and dip half of the absorbent pad into the urine for at least 10 seconds. Re-cap the pregnancy test midstream and place it on the clean, flat surface.

STEP 3 - PREGNANCY TEST RESULTS

Wait for the colored bands to appear. Depending on the concentration of hCG in the test specimen, positive pregnancy test results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (5 minutes) is required. Do not read the test results after 10 minutes as this type of pregnancy test is designed for rapid determination only. The pregnancy test results may fade overtime.

INTERPRETATION OF RESULTS

Negative Pregnancy Test - Not Pregnant:
Only one color band appears in the control region. No visible band on the test region is present since hCG concentration is not present in urine or too low for detection. If you obtain a very faint test line it may be too early to confirm pregnancy. The pattern of increasing intensity of the test line over a period of few consecutive days is a much better predictor of pregnancy rather than any single reading.

Positive Pregnancy Test - Possibly Pregnant:
Distinct color bands appear on the control and test regions within 6-15 days of conception. The presence of both test and control lines indicate possible pregnancy. Color intensity of the test band may vary according to the concentration of hCG in urine. The higher the hCG concentration - the darker the intensity of the test line. Please confirm the results over a period of few days. The pattern of increasing intensity of the test line is a much better predictor of pregnancy rather than any individual reading. When you obtain consistent positive results please confirm the hCG concentration by a blood test or ELISA screening in the laboratory.

Invalid Pregnancy Test - Uncertain Results:
No visible bands in the control and test regions. Make sure to follow the above specified instructions for optimum results.

FOR BEST PREGNANCY TEST RESULTS
For early pregnancy tests, the intensity of the test line is directly proportional to the concentration of hCG in the range of 10-50mIU. Test results may vary between individuals depending on the concentration of hCG your body produces, as well as monitoring frequency, and testing techniques. The best method is to test once a day, preferably with the first morning urine, and monitor the pregnancy test results systematically. It is recommended to use fresh urine sample with minimum amount of fluid required to pass over the reactive membrane region since tests detect minute concentrations of hCG hormone. Read results at 5 minutes and discard the test afterwards.

PRECAUTIONS
1. For single in vitro diagnostic use only - use pregnancy test only once for urine screening.
2. Do not use pregnancy test kit beyond expiry date.
3. These are preliminary qualitative results which need to be confirmed by a blood test or ELISA techniques.
4. Keep away from moisture, direct sunlight, and away from children's reach as urine is infectious.

Note: This type of rapid test is used for preliminary qualitative screening of early pregnancy. It is usually used professionally to trigger other analytical procedures (blood test, ELISA, etc.) for quantitative determination of pregnancy conditions. If you suspect that you are pregnant, or have any concerns about pregnancy, it is recommended that you consult with your physician. If you need any assistance please feel free to contact us with your detailed inquiry. We are here to help!

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