One step LH ovulation Urine test  strip

　

   INTENDED USE

  The ovulation Test is a self-testing immunochromatographic one- step assay designed for in vitro qualitative determination of human Iuteinizing hormone (hLH) in urine to predict time of ovulation.

  SUMMARY AND EXPLANATION OF TEST

  Ovulation is the release of an egg from your ovary. A low background level of Luteinizing Hormone (LH) is always present in your urine. At about the middle of your monthly cycle, the LH increases suddenly to a high surge level which causes the release of an egg from your ovary (ovulation) about 14 to 48 hours later. To become pregnant, the egg must be fertilized with a sperm cell in time. Therefore, your most fertile time is when you are ovulation. This test can help you predict your ovulation time quickly and easily. 

　

  PRINCIPLES

  The ovulation Test is a qualitative, two site sandwich immunoassay (2-3) for the determination of human Luteinizing hormone (hLH)  in urine. The membrane was pre-coated with goat anti-hLH on the test band region and goat anti-rabbit on the control band region. During the test, the patient urine is allowed to react with a colored conjugate (mouse anti-hLH monoclonal antibody-colloid gold conjugate) which was predried on the test strip. The mixture then moves upward on the membrane chromatographically by a capillary action. When hLH is present in the sample, a color band with a specific anti-hLH-colored conjugate complex will form on the membrane. On the other hand, a light color band will always appear at the control region. This control band serves as a reference of the color intensity of approximately 25 mIU/mL LH. When the intensity of test band is higher than that of control band the test is positive, indication the LH surge is likely in process.

  REAGENTS

　

  Each Ovulation Test strip individually sealed in a foil pouch   

   Ingredients:Test device consists of colloidal gold, 1.2mg/mL goat anti rabbit IgG, 4mg/mL alpha HCG antibody and 10ug/mL rabbit anti  LH antibody.

  MATERIALS PROVIDED

   Each pouch contains:

  1.    One ovulation Test strip

  2.    Desiccant

  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.

  Warnings

   For IN VITRO DIAGNOSITC USE ONLY

      1.Read directions for use carefully before performing this test. Pay attention to the position of the C and T line.

  2. Do not use beyond the labeled expiration date.

  3. Do not reuse the test devices. Discard it in the dustbin after single use.

  4. Do not use if pouch is damaged or opened.

  5.Do not touch the membrane on the strip

      6.Once open the pouch, the test device should be used immediately. Prolonged exposure to ambient humidity will cause product deterioration.

     7. Treat urine samples and used devices as if they are potentially infectious. Avoid contact with skin

  8. Examine if the urine cup exists before usage.  

  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 31st, 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 D=P+(A-17)  For example, your usual cycle length A is 29 days. Your first day of last menstruation P is 3rd, so you should begin testing on day 15th.

　

    

　　

  2.Specimen collection

  The ovulation Test is formulated for use with fresh urine specimens. The test should be used right after the specimen collection. 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 strip from the foil wrapper

2.          Immerse the strip into the urine with the arrow end pointing toward the urine.

    Do not cover the urine over the MAX ( maximum) line. Take the strip out after a minimum of 15 seconds in the urine and lay the strip   flatly on a non-absorptive clean surface.

3.          Wait for colored bands to appear. 5 minutes is required for a complete reaction. DO NOT INTERPRET RESULT AFTER 10 MINUTES.

    4.  Discard the test device after single use into a dustbin

   4. INTERPRETATION OF RESULTS

  Negative

   If only control line appears; or the test line is much lighter than the control line, the test result is negative which means no LH surge is detected.

   Positive

 If both Test line and Control line are visible and the test band is darker than or equal to the control band, the test result is positive which means the ovulation will happen in the next 24~48 hours.

  Invalid:

  If there is no distinct pink-purple colored band visible both in the TEST area and CONTROL area the test is inconclusive.  It is recommended that in this case the test be repeated.