Semi-quantitative LH One step Ovulation Test

（3 in 1 dipcard）

  For Self-testing and In Vitro diagnostic use only    

INTENDED USE

The Semi-quantitative LH One step Ovulation Test （3 in 1 dipcard） is a self-testing immunochromatographic one- step assay designed for in vitro qualitative determination of human Luteinizing hormone (hLH) in urine to predict time of ovulation. 

PRINCIPLES 

On each strip, if only quality control line (C line) appears, or the testing line (T line)’s colored band is lighter than the C line, it comes to the negative result. If T line’s colored band is no lighter than the C line, it comes to the positive result.

The LH level in the urine sample can be semi-determined as per the different results of 3 test strips with different critical LH values.

MATERIALS PROVIDED

Each box contains 1. Semi-quantitative LH One step Ovulation Test （3 in 1 dipcard）foil pouch, and 2. Package insert

Materials required but not provided

1. Timer and 2. Specimen collection container

STORAGE AND STABILITY

Store test strip at 4~30°C (room temperature). Avoid sunlight. The test is stable until the date imprinted on the pouch label.

ASSAY PROCEDURE

1. DETERMINATION OF TEST DATE       

First you must determine your usual cycle length. To do this, count the number of days from the day your period(menstrual bleeding) begins to the day before your next period begins. Using “A” represents it as menstrual cycle length; For example, if your period starts on the first day of the month and your next period begins on the 31^st, your cycle length is 30 days. Using “P” represents the first day of last menstruation. Use below formula to determine the first day of test which is represented by D=P+(A-17)

For example, your usual cycle length A is 29 days. Your first day of last menstruation P is 3^rd, so you should begin testing on day 15^th.

2.SPECIMEN COLLECTION AND HANDLING

The Semi-quantitative LH One step Ovulation Test （3 in 1 dipcard） is formulated for use with fresh urine specimens. The test should be used right after the specimen collection. Urine cup should be used to collect specimens, and the urine does not require any special pretreatment.

Choose a convenient time of the day to collect urine. Try to collect urine at about the same time each day for the entire cycle. For best results, collect between 10:00 am and 8:00 pm.

3. TEST PROCEDURE

1.  Remove the test dipcard from the foil pouch, and  remove  the cap from the midstream..

2.   Submerge the tip of  the test device into the urine sample in a urine cup for 10-20seconds . Remove the test dipcard from the urine, replace the cap and lay the test on a flat surface with the result window facing up.

3.  Read results within5～ 10 minutes.

4. INTERPRETATION OF RESULTS

a) Invalid result: none of the strips’-controlled zone show colored band in ten minutes

b) Negative (-) result: To each single strip, only control line appears; or the test line is much lighter than the control line, the test result is negative. If all three strips showed negative result, we can get full negative result.

c) Positive result: Test line and Control line are visible, and the test line is darker than or equal to the control line, the test result is positive. It includes following three situations:

     Positive（+）：when the LH concentration of the sample reaches 25mIU/mL～45mIU/mL , all the three strips shows control line. Only the test line on strip I is darker or equal to the control line. Other strips’ test line is lighter than the control line.

      Positive (++): when the LH concentration of the sample reaches 45mIU/mL～65mIU/mL , all the three strips shows control line. Test line on strip I is darker than the control line. Test line on Strip II is darker or equal to the control line. Test line on Strip III is lighter than the control line.

             Positive (+++):when the LH concentration of the sample reaches 65mIU/mL, all the three strips shows control line. Test line on strip I and Strip II is darker than the control line. Test line on Strip III is darker or equal to the control line.

Attention: minimum detectable LH concentration: strip I /25 mIU/mL; strip II/45 mIU/mL; strip III/ 65 mIU/m