SureSign Pregnancy Test (UPT) – 2’s

Details

The SureSign Urine Pregnancy Test (UPT) Strips are rapid, simple diagnostic devices providing early and accurate detection of pregnancy from the comfort of home. Its high sensitivity and clarity support women by offering quick information to facilitate timely decisions regarding prenatal care. The twin-pack offers excellent value and convenience, which is highly relevant in Tanzania where access to healthcare may require travel, allowing for an affordable follow-up re-test.

Available Models/Sizes/Variations

This product is offered as a Twin Pack (2’s) of test strips, individually sealed in foil pouches for maximum integrity. It boasts a high sensitivity level, detecting hCG concentrations as low as 15 mIU/mL, which is often higher sensitivity than many standard alternatives. A different model, the “6-Day Early” test, is also available for ultra-early detection.

Main Intended Uses

The primary intended use is the qualitative detection of human Chorionic Gonadotropin (hCG) in urine to aid in the early detection of pregnancy. The test can be accurately used as early as 4 days before the period is due, giving women the earliest possible confirmation. Localized Benefit: Early confirmation of pregnancy encourages mothers-to-be to enroll in prenatal clinics earlier, significantly boosting health outcomes for both mother and child in the region.

Operating Instructions

1. Collect/Prepare: Use the first morning urine, as it is the most concentrated. Bring the sealed pouch to room temperature.
2. Test: Expose the absorbent tip to urine for 5 seconds (midstream) OR dip the tip into a collected urine sample for 10-15 seconds. Do not exceed the MAX line on the strip.
3. Wait: Place the strip on a clean, non-absorbent, flat surface and wait exactly 3 minutes.
4. Read Result: Look for colored lines in the Control (C) and Test (T) regions.
5. Interpretation: Two lines (C and T) = Positive (Pregnant). One line (C only) = Negative (Not Pregnant). No line at C = Invalid.

Potential Risks/Adverse Events

There are no direct biological adverse effects from using the test. The main risk is obtaining a false-negative result if the test is performed too early (when hCG levels are low) or if the urine is diluted by over-hydration. There is a risk of misinterpretation if the result is read after the 10-minute maximum window due to the formation of faint evaporation lines.

Interactions/Compatibility

The test is compatible with urine samples but should not be used with samples exposed to high heat or contaminants. Results may be affected by drugs containing the hCG hormone (commonly used in fertility treatments). Other common medications like pain relievers or antibiotics do not typically interfere with the result.

Warnings/Precautions

For External Diagnostic Use Only. Do not ingest or reuse the test. Follow the instructions strictly, especially the reading time, to ensure accurate results. A negative result followed by a missed period should be re-tested a few days later. Localized Warning: Store the test in a cool, dry place, ensuring it is kept away from the high ambient temperatures and humidity often found in coastal or tropical areas of Tanzania, as excessive heat can compromise the chemical reagents.

Quick Device Facts Table

Mechanism of Operation

The SureSign test uses a form of Chromatographic Immunoassay. The test membrane is pre-coated with anti-hCG antibodies. When the urine sample containing hCG travels up the strip, it binds to the colored particles in the reaction zone. This complex then travels further and binds to the immobilized antibodies in the Test (T) region, forming a distinct colored line. A second line forms in the Control (C) region (which contains different antibodies) regardless of hCG presence, confirming the test procedure was performed correctly and the reagents are active.