CE Singclean Luteinizing Hormone (LH) Ovulation Test Kit

(Colloidal Gold)

For Self Testing Specimens: Urine

CE 0123 

[Product Name]

Generic Name: Luteinizing Hormone (LH)Ovulation Test Kit (Colloidal Gold)

[Intended Use]Please read all the information in this instruction for use before performing the test.

it is intend for qualitative determination of LH levels in women urine to predict ovulation time, so as to guide reproductive women to choose the optimal conception time or safe period contraception.

[Principle]

Luteinizing Hormone(LH)Ovulation Test Kit based on the principle of colloidal gold labeling technique and immune chromatography of double-antibody sandwich method. During testing , the LH in urine specimen migrates via capillary action along the membrane to react with LH monoclonal antibody conjugated with nanoscale colloidal gold particles forming an antibody-antigen complex.

[Kit Contents]

Strip / Cassette / Midstream, Dropper (for test cassette), Instruction for use, Desiccant.

[Equipment Required But Not Supplied]

Stopwatch, Disposable plastic container.

[Storage and Expiry Date]

·Store the kit at 4~30℃, keep in a cool and dry place, protected from light. Do not freeze.

·See the package with expiry date.

[Specimen collection]

1.Collect urine sample at 10:00 ~ 20:00 every day in order to get the best results. Do not collect urine urinated after waking up in the morning.

2.Liquid beverage should be restricted 2 hours, before collecting urine sample.

3.Use disposable plastic or glass container which is clean, dry and not contain any preservatives to collect fresh urine samples.

4.lf not tested immediately, the urine samples can be stored at room temperature for 4 hours or at 2~8℃ for 12 hours, do not freeze. To achieve the best results, please take test on the day of urine collection. If the urine refrigerated, please standing at room temperature for about 30 minutes before the test.

5. If there is sediment at the bottom of the container, please use the supernatant from the top of the container.

[Instruction]

Determine the day to start testing:

First, confirm the menstrual cycle length, that means how many days from the first day of the period (menstrual bleeding) to the next period starts. Please recall recent average days of the menstrual cycle. Then reference to the following table (Table 1.) determine test interval.

Last, determine the day to start testing. Starting from and including the first day of the last period, count ahead the number of interval days. Generally, it is recommended to conduct the test once a day for 5 days.

For example, menstrual cycle is 28 days, the Interval days is 11 days according to Table 1. If the last period is on 3, Wednesday, the day to start testing is on 13, Saturday. Conduct the test once a day until 17, Wednesday.

( ): The first day of the last period;< > : The day to start testing

Note: lf it is uncertain about how many days in a menstrual cycle, please use the shortest menstrual cycle (21 days) to calculate the test starting date. In this case, it is recommended to conduct the test once a day for 10 days. If your menstrual cycle is less than 21 days or more than 40 days, please consult professional doctor for the date of starting test.

Testing

1.Urinate into a clean, dry cup or container.

2.Remove the test kit from the foil pouch and familiarize yourself with the product. The test kit should be used as soon as possible especially at temperature higher than 30℃ or highly humidity environment.

3.Strip:Put the test strip in the urine sample at the direction of arrow. Do not pass max line. Wait for at least about 5s and then immediately lay the test kit on a flat surface.

Cassette: Put the test cassette on the table, add 3 full drops urine vertically into sample well (S ) by dropper.

Midstream: Remove the midstream cap, put the test midstream in the urine sample container Wait for at least about 5s and then lay the test kit on a flat surface. If you prefer, tip pointing downward directly into your urine stream.

4.Wait for about 5 minutes and then read the result. Don't read the result after 10 minutes.

[Result Interpretation]

Positive (+) : Two red lines are visible. One is located in the test line region (T), the other is in control line region (C).And the line in test line region (T) is the same as or darker than the one in the control line region (C) It indicates probable ovulation in 24-48 hours.

Negative (-) : One or two red lines are visible. One is located in the test region (T), the other is in control region (C).And T line is lighter than the C line, or there was no T line. It indicates that no LH surge has been detected.

Invalid: There is no red line in control region (C).Incorrect operation or the product has been damaged are the most likely reasons. Please repeat the test with a new test. If the problem still exists, should stop using the product immediately and contact with local suppliers.

[Limitations]

1.This test may not be used as a form of birth control.

2.lt is not affect the test results when taking painkillers, antibiotics or other common drugs, but drugs contain human Chorionic Gonadotropin (hCG) or LH may affect the test results. So users should avoid taking drugs contain hCG or LH before the test. In addition, it is not applicable for women who were pregnant, in menopause or contraceptive used.

3.Sterility treatments, based on LH, may cause false results. Consult your physician.

[Performance Characteristics]

1.Sensitivity:

The Luteinizing Hormone (LH) Ovulation Test Kit detects LH at a concentration of 25mlUl/mL or greater.

2.Specificity:

2.1 Cross-reactivity: The results are negative when detect follicle stimulating hormone (FSH, 200mlU/mL)and thyroid stimulating hormone (TSH,250 μlU/mL).

2.2 Interfering substances: The following potentially interfering substances have been detected. None of the substance sat the concentration tested interfered in the assay, and the urine with pH (from 4 to 9) also did not interfere the test result.

3.Precision:

Detecting the LH control materials at the same concentration, the results are consistent, and signal intensity (color) almost be same.

[Notice]

1.Only use for in vitro diagnostic, and cannot reused.

2.Please do not use when the pouch is damaged, and use the product before expiry date printed on the foil pouch.

3.The handling and disposal of used kit and urine specimens should be made, because maybe there is potentially infection or other biological hazards.

4.Humidity and temperature may affect the result.

5.Keep out of the reach of children.

6.Users should not take any decision of medical relevance without first consulting his or her physician.

Latest version 8.25.04.508 A4 Issue date: 2020.11.04