hCG Pregnancy Test Strip, CLIA Waived, 50 per Box

hCG Pregnancy Test Strip, CLIA Waived, 50 per Box provides fast, reliable urine-based pregnancy screening for professional testing environments. Designed to detect human chorionic gonadotropin (hCG), this dip-strip test offers a simple and economical solution for clinics, physician offices, women’s health programs, and other point-of-care settings. Each box contains 50 individual test strips for routine screening and bulk-use applications.[page:1]

Product Information

Human chorionic gonadotropin (hCG) is a hormone produced by the developing placenta shortly after conception and secreted into the urine. This pregnancy test contains antibodies that specifically react with hCG to help detect pregnancy quickly and accurately. Its dip-strip format is easy to use and provides dependable results for routine screening and early detection needs.

Product Specifications

Brand	Healgen Scientific
SKU	GAHCG-101a
Test Format	Urine dip strip
Analyte	Human chorionic gonadotropin (hCG)
Specimen Type	Urine
Sensitivity	25 mIU/mL hCG
Accuracy	99%
Result Time	Fast results in minutes
Early Detection Window	6 to 8 days after conceiving and before a missed period
Quantity	50 test strips per box
Result Display	Line-based
Classification	FDA 510(k), CLIA Waived

Key Features

• Highly sensitive detection: Detects hCG at levels of 25 mIU/mL.
• Reliable performance: Designed to deliver accurate pregnancy screening results when used as directed.
• Early detection capability: Supports early pregnancy testing in urine-based screening applications.
• Simple dip-strip format: Easy to use in professional and routine screening environments.
• Fast visual results: Line-based result format allows quick interpretation.
• CLIA Waived: Suitable for eligible point-of-care and professional testing settings.
• FDA 510(k) cleared: Supports confidence in regulated testing environments.
• Bulk 50-count box: Ideal for clinics, physician offices, and recurring screening needs.
• Cost-effective option: Practical for high-volume pregnancy testing programs.

How Does It Work?

Human chorionic gonadotropin (hCG) is a hormone produced by the developing placenta shortly after conception and secreted into the urine. The pregnancy test contains antibodies that specifically react with this hormone. When the strip is immersed in a urine specimen, capillary action carries the specimen along the membrane. When hCG in the sample reaches the Test Zone region of the membrane, it forms a colored line. Absence of this colored line suggests a negative result. To serve as a procedural control, a colored line will appear at the Control Zone region if the test has been performed properly.

How to Read Results

Negative (Not Pregnant): Only one color band appears in the Control Zone. No apparent band appears in the Test Zone. This indicates that no pregnancy has been detected.

Positive (Pregnant): Distinct color bands appear in both the Control and Test Zones. This indicates pregnancy. The color intensity of the test bands may vary since different stages of pregnancy have different concentrations of hCG hormone.

Invalid: No visible band appears at all, or there is a visible band only in the Test Zone and not in the Control Zone. Repeat the test with a new test kit. If the test still fails, contact the distributor where the product was purchased and reference the lot number.

Questions & Answers

1. What does this pregnancy test detect?
This test detects human chorionic gonadotropin (hCG), a hormone produced shortly after conception and present in urine.

2. How sensitive is this hCG pregnancy test?
This test is designed to detect hCG at 25 mIU/mL.

3. What does a positive result look like?
A positive result shows two distinct colored lines: one in the Control Zone and one in the Test Zone. The darkness of the test line may vary depending on hCG concentration.

4. How do I know the test worked correctly?
A colored line must appear in the Control Zone for the result to be valid. If no control line appears, the test is invalid and should be repeated with a new strip.

5. Who is this product ideal for?
This product is well suited for clinics, physician offices, women’s health programs, and other professional screening environments needing a simple, cost-effective pregnancy test strip.