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 professional users (doctors, clinics, family planning centres) 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 products are manufactured in ISO 9001 facility and posses Health Canada and US FDA 510k clearance. The product performance has earned an international reputation for quality and reliability, and are distributed in over 70 countries worldwide.
Sensitivity: 20mIU/mL hCG Storage: 2-30 degrees
Specificity: >99.9% Test any time of day
Reaction time: 5 minutes Integrated test control line
TEST PROCEDURE
STEP 1
Bring the 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 test from the pouch when you are ready to use it.
STEP 2 STRIP TEST
Immerse the strip into the urine with the arrow end pointing towards the urine. Do not immerse past the MAX (maximum) line. Take the strip 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 for longer than 5 seconds.
STEP 3
Wait for the colored bands to appear. Depending on the concentration of hCG in the test specimen, positive 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 results after 10 minutes as this type of test is designed for rapid determination only.
INTERPRETATION OF RESULTS
Negative - 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.
Positive - Pregnant:
Distinct color bands appear on the control and test regions. 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, hence higher the likelihood of pregnancy.
Invalid - Uncertain Results: No visible bands in the control and test regions. Make sure to follow the above specified instructions for optimum results.
The intensity of the test line is directly proportional to the concentration of hCG in the range of 10-50mIU. Test results may vary for different individuals depending on the concentration of hCG your body produces, as well as monitoring frequency, and testing technique. The best method is to test once a day, at a specific time, by closely following these test instructions.
PRECAUTIONS
1. For single in vitro diagnostic use only - use test only once for urine screening.
2. Do not use test kit beyond expiry date.
3. Keep away from moisture, direct sunlight, and children.
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 on pregnancy, it is recommended that you see your physician.
Overview
One Step LH Urine Ovulation Test is fast and easy-to-use. It is a qualitative test that predicts LH (Luteinizing Hormone) surge, and in turn, when you are likely to ovulate and conceive. Females who are trying to become pregnant may use this information to improve their chances of conception. Luteinizing Hormone is a hormone released by the pituitary gland, a small gland at the base of the brain. The hormone stimulates the ovaries to produce and release eggs each month during the menstrual cycle. The level of LH in the blood and urine is highest before ovulation. This increase in hormone level is sometimes called a "surge". If fertility drugs are given to stimulate ovulation, an LH test can help determine the best time for sexual intercourse. The LH test may also be used to determine when eggs are mature enough to be surgically removed from the ovary as part of the in vitro fertilization process. LH tests may also aid in the diagnoses of polycystic ovary disease, premature ovarian failure, and menopause.
The tests detect LH in urine in a qualitative format with sensitivity of 25mIU/mL (International Standard Value) and specificity is 99.8%. Tests have an expiry date of 2 years and can be stored in a dry environment ranging from 2 to 30 degrees Celsius. Results are available in just minutes.
Sensitivity: 25mIU/mL LH Storage: 2-30 degrees
Specificity: >99.8% Test any time of day
Reaction time: 10 minutes Integrated test control line
WHEN TO BEGIN TESTING
First, you must determine the length of your menstrual cycle. This is the number of days from the first day of your menstrual bleeding to the day before your next bleeding begins again. Please refer to the chart below to determine when you should start testing. If your cycle is shorter than 21 days or longer than 38 days, consult your doctor. If you do not know your cycle length, you may begin the test 11 days after your first period since the average cycle length is 28 days. Perform 1 test each day over a 5 day period or until the LH surge has been detected.
URINE COLLECTION
1. Do not use first morning urine samples as LH is synthesized in your body early in the morning. It will not show up in your urine until later in the day.
2. The best time to collect your urine is between 10am - 8pm.
3. Collect urine at about the same time each day.
4. Reduce liquid intake about 2 hours before collecting your urine as a diluted urine sample can prevent the test from detecting LH surge.
Please refer to the table below for information on when to start using ovulation tests:
Your Cycle Length Start To Test On
21 days Day 6
22 days Day 6
23 days Day 7
24 days Day 7
25 days Day 8
26 days Day 9
27 days Day 10
28 days Day 11
29 days Day 12
30 days Day 13
31 days Day 14
32 days Day 15
33 days Day 16
34 days Day 17
35 days Day 18
36 days Day 19
37 days Day 20
38 days Day 21
TEST PROCEDURE
STEP 1
Bring the 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 test from the pouch when you are ready to use it.
STEP 2
STRIP TEST
Immerse the strip into the urine with the arrow end pointing towards the urine. Do not immerse past the MAX (maximum) line. Take the strip out after 5 seconds and lay the strip flat on a clean, dry, non-absorbent surface (e.g., mouth of the urine container). Do not immerse for longer than 7 seconds.
STEP 3
Wait for colored bands to appear. Depending on the concentration of LH in the test specimen, positive results may be observed in as short as 40 seconds. However, to confirm negative results, the complete reaction time (10 minutes) is required. Do not read the results after 30 minutes as this type of test is designed for rapid determination only.
INTERPRETATION OF RESULTS
No LH Surge:
Only one color band appears on the control region or the test band is present but lighter in color intensity than the control band. There is no LH surge even if two lines present - as long as test line is fainter than the control line the result is negative.
LH Surge:
If two color bands are visible and the test band is equal to or darker than the control band, one will probably ovulate in the next 24-48 hours. If one wants to be pregnant, the best time to have intercourse is after 24 hours but before 48 hours.
Invalid - Uncertain Results: No visible bands in the control and test regions. Make sure to follow the above specified instructions for optimum results.
Test results may vary for different individuals depending on the concentration of LH your body produces, as well as monitoring frequency, and testing technique. The best method is to test once a day, preferably later in the afternoon or early evening.
PRECAUTIONS
1. For single in vitro diagnostic use only - use test only once for urine screening.
2. Do not use test kit beyond expiry date.
3. Keep away from moisture, direct sunlight, and children.
Note: If you suspect that you have ovulation problems, or problems with detecting LH surge, please see your physician. There are numerous stimulatory procedures that can induce the ovulation surge.
