Online Pregnancy Test Instructions Accurate Pregnancy Tests Home Pregnancy Tests Home  
  Go to Order Catalog
 
Cart Contents
 

Online Pregnancy Test Instructions

IMPORTANT

Our online 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. If you have any questions, please don't hesitate to contact us.

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 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
Click a thumbnail to enlarge
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
Click a thumbnail to enlarge
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.
Click here for detailed explanation and graph.

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 IU 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).
  3. 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.

  4. 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 (2C to 30C) 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.

PRIORITY ASSISTANCE

Our customer service team will be glad to offer assistance so please feel free to contact us with your detailed inquiry.

TECHNICAL REFERENCES

1. Batzer FR, Fertility & Sterility, Vol. 34, 1, 1980. 2. Braunstein GD, Rasor J, Alder D, Danzer H, Wade ME. Am.J. Obstet. Gynecol., Vol 126, 678, 1976. 3. Braunstein GD, et al. Ann. Inter. Med. Vol. 78, pp 39-45, 1973. 4.Catt KJ, Dufan ML & Vaitukaitis JL. J. Clin. Endocrinol. Metab., Vol 40, 537, 1975. 5. Dawood MY, Saeba BB, & Landesman R. Ob. Gyn. Vol. 126, 678, 1976. 6. Engvall E. Methods in Enzymology, Vol. 70, pp 419-439, 1980. 7. Lenton EA, Neal LM, Sulaiman R. Fertility & Sterility, Vol. 37, 773, 1982. 8. Uotila M, Ruoslahti E, Engvall E. J. Immunol. Methods, Vol. 42, 11, 1981.
 
Why Shop With Us?
  • Best Prices
  • Highest Quality
  • Discreet Shipping
  • Secure Payments
  • Excellent Customer Service
Find out more...