PERFORMANCE CHARACTERISTICS

Accuracy

A multi-center clinical evaluation was conducted comparing the results obtained using the hCG One Step Pregnancy Test Midstream (Urine) to another commercially available urine membrane hCG test. The study included 150 urine specimens, and both assays identified 72 negative and 78 positive results. The results demonstrated >99% overall accuracy of the hCG One Step Pregnancy Test Midstream (Urine) when compared to the other urine membrane hCG test.

DIRECTIONS FOR USE

Allow the test, urine specimen and/or controls to reach room temperature (15-30℃) prior to testing.

• Bring the pouch to room temperature before opening it. Remove the test device from the sealed pouch and use it as soon as possible.
• Place the test device on a clean and level surface. Hold the dropper vertically and transfer 3 full drops of urine (approx. 100 mL) to the specimen well (S) of the test device, and then start the timer. Avoid trapping air bubbles in the specimen well (S). See illustration below.
• Wait for the colored line(s) to appear. The result should be read at 3 minutes.

NOTE: A low hCG concentration might result in a weak line appearing in the test line region (T) after an extended period of time; therefore, do not interpret the result after 10 minutes.