What are pregnancy and fertility testing?

Pregnancy and fertility testing are diagnostic methods used to determine a woman’s pregnancy status or evaluate the potential of an individual or couple to conceive. Both pregnancy and fertility testing are helpful tools that guide individuals and couples in their family planning journey, providing essential information and clarity. Always consult with a healthcare provider when considering these tests to ensure they are appropriate and interpreted correctly.

• Pregnancy tests detect the presence of the hormone human chorionic gonadotropin (hCG) which is produced shortly after a fertilized egg attaches to the uterine lining. 
• Fertility tests evaluate the ability of an individual or couple to conceive and identify any potential issues that might be affecting their fertility. 

Types of fertility tests:

• Ovulation test: Determines most fertile days and evaluates fertility issues. Ovulation tests are used to detect luteinizing hormone (LH) to aid in the detection of ovulation.
• Menopause test: Evaluates fertility issues and aids in the detection of menopause by detecting follicle stimulating hormones (FSH) levels.

FSH, LH, and hCG Test

These hormones provide insight on the reproductive system. Tests for these hormones help assess various aspects of reproductive health and function.

FSH

Follicle Stimulating Hormone (FSH) is a hormone released by the anterior pituitary gland. In women, it helps manage the menstrual cycle and stimulates the ovaries to produce eggs. FSH testing helps determine the cause of infertility, diagnose conditions like polycystic ovary syndrome (PCOS) or primary ovarian insufficiency, and confirms the onset of menopause.

LH

Luteinizing Hormone (LH) is a hormone produced by the anterior pituitary gland. In women, an LH surge triggers ovulation and egg release. LH testing helps assess menstrual cycle irregularities and predict ovulation for those trying to conceive. 

hCG

Human Chorionic Gonadotropin (hCG) is a hormone produced in the body during pregnancy shortly after a fertilized egg attaches to the uterine lining. hCG testing is an ideal marker for the early detection and confirmation of pregnancy.

What is a Pregnancy Test?

A pregnancy test is a diagnostic tool used to determine if an individual is pregnant. It does so by detecting the presence of the hormone human chorionic gonadotropin (hCG) in urine or blood samples. 

Rapid Response™ Pregnancy tests are rapid tests for the qualitative, presumptive detection of human chorionic gonadotropin (hCG) in human urine or serum (a component of blood) specimens. It is intended for use as an aid in the early detection of pregnancy. 

Human chorionic gonadotropin (hCG), a glycoprotein hormone secreted by viable placental tissue during pregnancy, is excreted in urine. The appearance of hCG in urine soon after conception and its rapid rise in concentration makes it an ideal marker for the early detection and confirmation of pregnancy. All Rapid Response™ Pregnancy Tests detect hCG at a concentration of 20 mlU/mL, this concentration is typically present 7-10 days after conception or 4-5 days prior to the first missed menses making it a good early indicator of pregnancy. 

Why are Pregnancy Tests Used?

• Suspected Pregnancy: Individuals who suspect themselves to be pregnant, typically due to symptoms or a missed period.
• Before Medical Procedures: To ensure a patient isn’t pregnant before undergoing certain medical treatments which can have adverse effects on pregnancies. 
• Fertility Treatments: Individuals attempting to get pregnant, and their doctors may continuously monitor their hCG levels after fertility treatments.

Where are hCG Strips Used?

• Personal testing using at home pregnancy tests
• Healthcare settings using point of care pregnancy tests
• Fertility clinics using point of care pregnancy tests 

What are Pregnancy Test Strips?

A pregnancy test strip is a lateral flow test saturated with chemicals that react with human chorionic gonadotropin (hCG). When dipped in urine, if hCG is present at or above a specific concentration, two colored lines will appear on the strip, indicating a positive result.

Technical Details: 

• Anti-hCG antibodies are immobilized on the test region of the membrane and anti-mouse antibodies on the control region. During testing, the specimen reacts with anti-hCG antibodies conjugated to coloured particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient hCG in the specimen, a coloured band will form at the test region of the membrane. The presence of this coloured band indicates a positive result, while its absence indicates a negative result. The appearance of a coloured band at the control region serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.

What are Midstream / Pregnancy Test Sticks?

A pregnancy test stick, also referred to as a midstream test, is a plastic device with an absorbent tip that is designed to be held in the urine stream or dipped in collected urine for a few seconds to absorb the sample directly. The urine is absorbed and travels up the stick, reaching the reactive zone. A control line usually appears to indicate the test is working. If hCG is present, a second line will appear, indicating pregnancy. It contains the same reactive chemicals as the test strip, but it is typically housed in a plastic casing with a window to show results and a handle for ease of use. 

What are Pregnancy Test Cassettes?

A pregnancy test cassette contains a test strip housed in a plastic casing with a designated spot, the specimen well, and a window to show results. The urine or serum sample is typically added to the specimen well using a dropper.

What are the Different types of Pregnancy Tests?

There are primarily three varieties of pregnancy test formats: midstreams, cassettes and strips. All three can be used with urine samples, and some cassettes and strips can be used with serum samples.

Rapid Response™ Midstream Pregnancy Test

• Detects hCG
• Sample: Urine
• Sensitivity: 20 mIU/mL or above
• Accuracy: >99%
• Format: Midstream
• Time to Results: 3 Minutes
• CLIA Waived and FDA cleared for OTC
• Test Method: Absorbent tip is held in urine stream; or absorbent tip is dipped in urine collected in a specimen collection cup.

Rapid Response™ Pregnancy Test Cassette

• Detects hCG
• Sample: Urine
• Sensitivity: 20 mIU/mL or above
• Accuracy: >99%
• Format: Cassette
• Time to Results: 3 Minutes
• CLIA Waived
• Test Method: Drops of urine are added to the specimen well of the cassette with a pipette or dropper. Specimen is collected from a specimen collection cup.

Rapid Response™ Pregnancy Combo Test Cassette

• Detects hCG
• Sample: Urine / Serum
• Sensitivity: 20 mIU/mL or above
• Accuracy: >99%
• Format: Cassette
• Time to Results: 5 Minutes
• Test Method: Drops of urine or serum are added to the specimen well of the cassette with a pipette or dropper. Specimen is collected from a specimen collection cup.

Rapid Response™ Pregnancy Test Strip

• Detects hCG
• Sample: Urine
• Sensitivity: 20 mIU/mL or above
• Accuracy: >99%
• Format: Strip
• Time to Results: 5 minutes
• CLIA Waived and FDA cleared for OTC
• Test Method: The test strip is dipped into urine collected in a specimen collection cup.

Rapid Response™ Pregnancy Combo Test Strip

• Detects hCG
• Sample: Urine / Serum
• Sensitivity: 20 mIU/mL or above
• Accuracy: >99%
• Format: Strip
• Time to Results: 5 minutes
• Test Method: The test strip is dipped into urine or serum collected in a specimen collection cup.

What can Pregnancy Tests Detect?

Pregnancy tests primarily detect the hormone hCG, which is produced shortly after a fertilized egg attaches to the uterine lining. Reportedly, a level of 20 mIU/mL or more is present 7-10 days after conception or 4-5 days prior to the first missed menses.

What is hCG?

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both serum and urine as early as 7 to 10 days after conception[1-4]. hCG level continues to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period[2-4] and peaking in the 30,000 – 100,000 mIU/mL range by 10-12 weeks into pregnancy.

Urine hCG concentration in pregnant women rises very rapidly after implantation, reaching a peak concentration in excess of 200 IU/mL about 2-3 months after the last menstrual period.

The appearance of hCG in urine soon after conception and its rapid rise in concentration makes it an ideal marker for the early detection and confirmation of pregnancy. However, elevated hCG levels are frequently associated with trophoblastic and non-trophoblastic neoplasm. Therefore, these conditions should be considered before a diagnosis of pregnancy can be made.

What are pregnancy test strips?

A pregnancy test strip is a piece of plastic coated with chemicals that react with human chorionic gonadotropin (hCG). When dipped in urine, if hCG is present, multiple colored lines will appear on the strip, indicating a positive result.

How do pregnancy test strips work?

The Rapid Response™ Pregnancy Test Strip (Urine) detects human chorionic gonadotropin through visual interpretation of color development on the strip. Anti-hCG antibodies are immobilized on the test region of the membrane and anti-mouse antibodies on the control region. During testing, the specimen reacts with anti-hCG antibodies conjugated to colored particles and precoated onto the sample pad of the strip. The mixture then migrates through the membrane by capillary action and interacts with reagents on the membrane. If there is sufficient hCG in the specimen, a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicating that the proper procedures for the test have been performed and that the test is working as intended.

During testing, the test strip is dipped in urine for at least 10-15 seconds. The test strip is then placed on a non-absorbent flat surface, and in 5 minutes, results will appear.

When is the best time to take a pregnancy test with a strip and can I use a pregnancy test strip at any time of day?

Although urine specimen from any time of day can be used, first morning urine specimens are preferable as they contain the highest concentration of hCG.

Are pregnancy test strips accurate?

Our Rapid Response™ Pregnancy Test Strips have an accuracy of >99%.

How soon can I take a pregnancy test after a missed period with a strip?

The Rapid Response™ Pregnancy Test Strip is capable of detecting pregnancy as early as 1 day after the first missed menses.

Can I get a false positive or false negative result with a pregnancy test strip?

Certain factors such as medications or very recent miscarriages may affect results.

When hCG levels are below the minimum detection level of 20 mIU/mL, a false negative result may be obtained.

Do all pregnancy test strips require the same method of use?

Pregnancy test strips are often used to test urine samples but depending on the test format, the method of use may differ. Test strips require dipping the strip in urine while a midstream test can be placed in a urine stream or dipped. A test that involves a test cassette requires urine to be collected in a pipette, which is then added to the sample well of the cassette to run the test. Some pregnancy test, such as the Rapid Response™ hCG Combo Cassette may also be used to test serum for hCG content. These test are typically used by medical professionals only. 

Where can I purchase pregnancy test strips?

Contact our Sales Representative to purchase Rapid Response™ tests.

What should I do if I get a positive result on a pregnancy test strip?

Visit a clinic and talk to a healthcare provider for a follow-up pregnancy test and advice on next steps.

When to Get a Pregnancy Test?

• After missing a period is the best time to get tested, though some tests can detect hCG a few days before an expected period.

• If pregnancy symptoms are experienced.

• A few days before an expected period with some highly sensitive tests.

How to get Pregnancy Tests?

Pregnancy test can be purchased over-the-counter at drugstores, pharmacies, or online. They can also be conducted at healthcare facilities. Contact our Sales Representative to purchase Rapid Response™ tests.

Can You Take the Test at Home?

Yes, Rapid Response™ Pregnancy Test kits authorized for at-home OTC use can be taken at home.

About the Results & Interpreting Results

• Positive: Typically, two lines or a specific symbol appears.

• Negative: Only the control line appears.

• Invalid: If no lines appear or if the control line doesn’t appear, the test results are not valid. Retesting should be performed.

References:

1. Batzer FR. Fertility and Sterility 1980; 34:1.
2. Catt KJ, Dufan ML, Vaitukaitis JL. J. Clin. Endocrinol. Metab. 1975; 40:537.
3. Baunstein GD, Rasor J, Adler D, Danzer H, Wade ME. Am. J. Obstet. Gynecol. 1976; 126:678.
4. Lenton EA, Neal LM, Sulaiman R. Fertility and Sterility 1982; 37:773.