Ultra Sensitive Early Detection Pregnancy Test Strips

The CLIA Waived Ultra Sensitive Pregnancy Test Strips offer a reliable and precise solution for early pregnancy detection, specifically designed to deliver quick, easy-to-read results at home. These FDA-cleared strips are 99.9% accurate, detecting the human chorionic gonadotropin (hCG) hormone—essentially confirming pregnancy as early as 8–9 days post-ovulation, or roughly 5 days before the expected menstrual period. With an ultra-sensitive threshold of just 25 mlU/mL hCG, these strips offer peace of mind for women looking for an early indication of pregnancy.

Benefits of Use

• Early Detection: Begin testing up to 8–9 days after ovulation, allowing for confirmation of pregnancy well before missed periods.
• Ultra Sensitivity: Detects hCG at low concentrations (25 mIU/mL), helping catch pregnancy signs in its earliest stages.
• FDA-Cleared and 99.9% Accuracy: Provides reliable results, giving users confidence and minimizing false readings.
• Convenience and Privacy: Test easily from the comfort of home, with a simple, one-step urine test.

• High Sensitivity Detection: Capable of identifying minute hCG levels, ensuring prompt results.
• Immunochromatographic Technology: Utilizes monoclonal antibodies for precise hCG hormone detection and accuracy in distinguishing pregnancy from other hormonal conditions.
• Quick Results: Easy-to-read, colored lines clearly indicate a positive or negative result within minutes.
• Internal Control for Reliability: The control line provides confirmation of a valid test, ensuring confidence in the results displayed.

How It Works

The CLIA Waived Ultra Sensitive Pregnancy Test Strip operates through Immunochromatography. When the urine sample soaks into the absorbent pad, hCG (if present) binds to the monoclonal antibodies in the test, forming a complex. This complex is captured in the test region, producing a colored line that indicates a positive result. The control line must appear on every valid test, confirming accuracy and reliability.

Test Procedures

Step 1

Remove the testing device from the foil pouch by tearing at the notch. Hold the strip by the colored end.

Step 2

Immerse the strip into the urine with the arrow end pointing towards the specimen. Do not immerse past the MAX line.

Step 3

Take the strip out after 3-5 seconds. Lay the strip ( MAX side facing up) flat on a clean, dry, non-absorbent surface.

Step 4

Wait for colored bands to appear and read results.
Positive results can be read as soon as it appears.
Negative results may be confirmed in 5 to 10 minutes.
Ensure that the background of the test area is white before interpreting the results.

Result Interpretations

Control Line ( C): The control line appears on every valid test, regardless of the result. Its presence confirms that the test is functioning correctly and that the sample has been absorbed properly. If the control line does not appear, the test is invalid and should be repeated with a new strip.

Test Line ( T): The test line appears only when hCG is detected in the sample. A visible test line indicates a positive result, suggesting pregnancy. If no test line appears but the control line does, the result is negative, indicating that hCG was not detected at the threshold level in the sample.

These lines ensure accurate readings, helping users interpret their results with confidence.

Negative

A pink colored band appears only at the control region

Positive

A clear pink control band and a detectable test band appear. This indicates pregnancy.

Invalid

No visible band at the control region. Repeat with a new test device. If test still fails, please contact the distributor with the lot number.

Warnings and Precautions

1. This test is designed for in vitro diagnostic use.
2. Read instructions carefully before using this test.
3. This kit is for external use only. Do not swallow.
4. Do not use the test kit beyond expiry date.
5. Do not use the kit if the pouch is punctured or is not well sealed.
6. Keep out of the reach of children.
7. Urine specimens may be infectious; Insure proper handing and discard all used devices according to the local regulations.
8. The test is for single use. Do not reuse it.

Note: Do NOT interpret results after 30 minutes.