 One Step Ovulation Test is an immuno-chromatographic in vitro assay for the qualitative or the semi-quantitative determination of human luteinizing hormone (LH) in urine to predict the time of ovulation in women. detects the sharp increase in LH concentration in urine, so called “LH surge”, that precedes ovulation.
Conception is most likely to occur within 36 hours following LH surge. Each pouch contains one immuno-chromatographic testing device and one disposable sample dropper. An testing device contains a test membrane with anti-LH antibodies and conjugates in a stabilizing matrix containing proteins and sodium azide. Storage conditions: below 28C; do not freeze. Limitations: Elevated concentrations of chorionic gonadotropin (hCG) interfere with LH testing. Do not test samples from pregnant women and people with pathologic conditions causing higher hCG levels. Do not use Ovuation test as an aid in contraception.
TEST PROCEDURE AND INTERPRETATION OF RESULTS For each daily test, collect a urine sample at about the same time. Do not use first morning urine. Use a clean, dry container. For best results, perform the test on the same day. If necessary, the sample may be stored for up to seven hours at room temperature, or up to 24 hours in a refrigerator. Do not freeze the test sample.
NOTES Do not open the foil pouch until you are ready to perform the test.
TEST PROCEDURE 1. Open a foil pouch by tearing along the “notch”. Remove the testing device and the sample dropper. Place the testing device on a flat horizontal surface. 2. Holding the dropper vertically, carefully dispense four drops of urine into the sample well (marked “S”) of the testing device. If migration of liquid is not seen in the test window within one or two minutes, add two more drops of urine.
3. Read the test results at five minutes.
INTERPRETATION OF THE TEST RESULTS Compare the intensities of the two color lines (bands): the control line in the control (“C”) region of the test membrane, and the test line in the test (“T”) region of the membrane. Positive The test line is of equal or greater intensity than the control line. LH surge is detected. NegativeThe test line is of lesser intensity than the control line, or the test line is not visible. LH level is not elevated (LH surge is not detected). InvalidThe test is invalid if the control line is not visible at five minutes. The test failed, or the test procedure was not followed properly. Verify the test procedure and repeat the test with a new testing device. |
