Pregnancy Cassette Test Kit
The Pregnancy Cassette Test Kit is a highly accurate, FDA and CLIA-Waived pregnancy test designed primarily for clinical and point-of-care environments. This test offers fast results in just 5 minutes, eliminating the need for extended 24–48-hour laboratory wait times. By detecting the hCG hormone at levels as low as 25 mlU/mL, it provides a reliable, convenient alternative to traditional lab testing without compromising accuracy. With competitive pricing and a shelf life of 16–24 months, the Pregnancy Cassette Test Kit is an ideal choice for clinics and healthcare providers aiming to streamline pregnancy testing efficiently.
Benefits of Use
- Quick, Reliable Results: Provides results in 5 minutes, supporting rapid patient decisions and reducing the wait time associated with laboratory tests.
- Laboratory-Level Accuracy: At 98% early detection accuracy, it is one of the most reliable pregnancy tests available, giving confidence in clinical settings.
- Cost-Effective: Designed with competitive pricing and bulk purchase options, making it an affordable choice for healthcare facilities.
- Extended Shelf Life: With a 16–24 month shelf life, it offers flexibility in inventory management and testing frequency.
Features
- High Sensitivity: Detects hCG at 25 mlU/mL, providing early and accurate pregnancy detection.
- FDA-CLIA Waived: Approved for over-the-counter use, ensuring compliance and quality for clinical and point-of-care settings.
- Optimized for Point-of-Care Testing: Suitable for immediate use in clinics, allowing for on-the-spot results.
- Bulk Purchase Options: Volume discounts available to help manage costs for high-demand environments.
The Pregnancy Cassette Test Kit is a trusted choice for rapid, accurate pregnancy testing, offering the convenience and precision needed in busy clinical settings.
How It Works
The CLIA Waived Ultra Sensitive Pregnancy Test Cassette 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 cassette from the foil pouch by tearing at the notch.
Step 2
Collect the Sample: Use a disposable
collection cup to collect a urine sample from the donor.
Step 3
With the dropper transfer 2-3 drops of specimen into the sample well market S.
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
- This test is designed for in vitro diagnostic use.
- Read instructions carefully before using this test.
- This kit is for external use only. Do not swallow.
- Do not use the test kit beyond expiry date.
- Do not use the kit if the pouch is punctured or is not well sealed.
- Keep out of the reach of children.
- Urine specimens may be infectious; Insure proper handing and discard all used devices according to the local regulations.
- The test is for single use. Do not reuse it.
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Note: Do NOT interpret results after 30 minutes. Do not read results before 5 minutes or after 10 minutes.
EXPIRATION DATE TO SHORT 
