Human Chorionic Gonadotropin (hCG) Rapid Test Uncut Sheet

Summary and Explanation

HCG is produced by the placenta during pregnancy, shortly after the embryo attaches to the uterine lining. Usually HCG can be detected by a home pregnancy test within 7-10 days after conception. This test is capable of detecting pregnancy as early as the first day after you miss a period. The further into the pregnancy you are, the higher the levels of HCG in your urine. This pregnancy test detects HCG in urine at a concentration of 25mIU/ml (Milli-International Units) or greater. The concentration of HCG in non-pregnant women is normally 5.0mIU/ml. At the time of the last missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 to 200,000mlU/ml seen at the end of the first trimester.

Test Procedure & Result Interpretation

Allow the test strip/cassette, specimen, and/or controls to reach room temperature (15-30"C) prior to testing.

Strip Procedure

1.Bring the pouch to room temperature before opening. Remove the test strip from the

sealed pouch and use it within one hour.

2.Dip the test strip into the urine sample as arrow marked on the strip at least for 5 seconds, the urine level should be not higher than the water mark on the strip. Then leave the strip on a flat surface.

3. Wait for the colored line(s)to appear. The test result should be read at 3 minutes. Do not interpret the result after 10 minutes.

Cassette Procedure

1.Bring the pouch to room temperature before opening. Remove the test cassette from the

sealed pouch and use it within one hour.

2.Place the test cassette on a clean and level surface. Hold the dropper vertically, draw the specimen and transfer the specimen to the sample well of the test cassette (two drops/approximately 50ul) to the sample well and start the timer. Avoid trapping air bubbles in the sample well.

3. Wait for the colored line(s)to appear. The test result should be read at 5 minutes. Do not interpret the result after 10 minutes.

Result Interpretation

Negative result: if there is only a quality control line C, the detection line is colorless, indicating that HCG has not been detected or the detecting level in the sample is lower than the cutoff and the result is negative.

Positive result: if both the quality control line C and the detection line appear, a pregnancy diagnosis has been detected and the result is positive.

Invalid result: if the quality control line C is not observed, it will be invalid regardless of whether there is detection line, and the test shall be conducted again.