Wondfo One Step hCG Pregnancy Urine Test Cassette | CLIA Waived

Wondfo One Step hCG Pregnancy Urine Test Cassette | CLIA Waived provides fast, professional urine-based pregnancy screening in a convenient cassette format. Designed for professional point-of-care use, this test detects human chorionic gonadotropin (hCG) in urine with a sensitivity of 20 mIU/mL and delivers easy-to-read visual results in approximately 3–5 minutes. Each box contains 25 individually packaged cassette tests and is well suited for clinics, physician offices, laboratories, and other professional testing environments.

Product Information

Human chorionic gonadotropin (hCG) is a hormone produced shortly after conception and is present in urine during pregnancy. The Wondfo cassette test is a rapid qualitative assay designed to detect hCG in urine for professional pregnancy screening. Its cassette format supports controlled specimen application with a dropper and includes a built-in procedural control for result verification.

Product Specifications

Key Features

• 20 mIU/mL sensitivity: Supports early detection of hCG in urine.
• Rapid 3–5 minute results: Delivers fast visual screening for efficient workflow.
• CLIA Waived: Suitable for qualifying waived testing environments.
• FDA 510(k) Cleared: Cleared for its intended professional use.
• Health Canada Class II: Listed for applicable Canadian regulatory classification.
• >99% specificity: Designed for reliable qualitative urine screening when used as directed.
• Cassette with controlled dropper application: Supports simple, consistent specimen placement.
• Built-in procedural control: Helps confirm proper test performance.
• Individually packaged: Sealed cassette format with dropper and desiccant for convenience.
• 25 tests per box: Practical pack size for clinics, labs, and healthcare practices.

Interpretation of Test Results

How Does It Work?

The Wondfo cassette pregnancy test detects human chorionic gonadotropin (hCG) in urine. After the urine specimen is collected, 3 drops are added to the sample well using the included dropper. The specimen migrates across the membrane, and if hCG is present at or above the test threshold, a colored line appears in the test region. A colored line in the control region confirms that the test has functioned properly.

How to Read Results

Negative (Not Pregnant): One colored line appears in the Control region only. No visible line appears in the Test region.

Positive (Pregnant): Two colored lines appear, one in the Control region and one in the Test region. The color intensity of the test line may vary depending on the hCG concentration in the specimen.

Invalid: If no control line appears, the result is invalid and the test should be repeated with a new device.

Frequently Asked Questions

1. What type of sample is used with this pregnancy test?
This test is designed for use with urine specimens and uses a cassette format for sample application and result interpretation.

2. How sensitive is the Wondfo One Step hCG Pregnancy Urine Test Cassette?
This pregnancy test has a sensitivity of 20 mIU/mL, which supports early qualitative detection of hCG in urine.

3. How long does it take to get results?
Results are typically available in approximately 3 to 5 minutes when the test is used according to the instructions.

4. Is this product CLIA waived?
Yes. This product is listed as CLIA Waived and is intended for qualifying professional point-of-care testing settings.

5. How many tests are included in each box?
Each box contains 25 individually packaged cassette pregnancy tests.