Pregnancy Test Instructions

IMPORTANT

Our pregnancy test instructions provide all the information that is needed to use our tests.
If used incorrectly, the tests will not be accurate, so please read the entire set of instructions
BEFORE beginning to test.

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. 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 peaks at around
100,000-200,000 mIU/mL by 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.

APPLICATION

Pregnancy Test Cassette Application

1.
Use the plastic pipette provided in the test pouch to withdraw the urine sample.

2.
Position the pipette over the round well opening and displace 4 drops of urine
by gently squeezing the pipette. 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 color 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 color bands appear on the Control (C) and Test (T) regions.



• Color 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.

PERFORMANCE CHARACTERISTICS

Sensitivity:
20 mIU/mL hCG detection limit

Specificity:
99% correlation was determined from cross reaction studies with known amounts of Luteinizing
Hormone (300 mIU hLH/mL ), Follicle Stimulating Hormone (1,000 mIU hFSH/mL), and Thyroid
Stimulating Hormone (1,000 µIU hTSH/mL).

Standardization:
World Health Organization First International Reference Preparation (WHO 1st IRP 75/537).
US FDA 510k and Health Canada Medical Device Licenses.

Reagents:
Containing membrane coated with goat anti-hCG colored colloidal gold - monoclonal mouse
anti-hCG conjugated predried in pad.

Interference Testing:
None of the substances at concentration tested interfered in the assay.

• Acetaminophen 20 mg/mL
• Acetylsalicylic acid 20 mg/mL
• Ascorbic acid 20 mg/mL
• Atropine 20 mg/mL
• Caffeine 20 mg/mL
• Gentesic acid 20 mg/mL
• Glucose 2 g/dL
• Haemoglobin 1 mg/dL

Built in Quality Control:
The procedural control is built in to the test. A color band appearing on the control region
of the strip indicates proper test performance.

The test will yield a positive result on the first day of missed menstrual period providing
the beta hCG concentration is in detectable range (20 mIU/mL).

Urine from healthy men and non-pregnant women will normally show undetectable levels
of hCG when tested with pregnancy tests. If unexpected results occur it is strongly
recommended to consult with a qualified specialist.

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.

WARNING AND PRECAUTION

1. Keep away from children and prolonged exposure to extreme storage conditions.
2. This test is designed for single in vitro diagnostic use only.
3. Do not use test kit beyond expiry date printed on package.
4. Tests results may vary for different individuals.
5. Confirm all test results with a qualified specialist.