DE Medical Technology Jiangsu Co.,Ltd 
Test Format: Strip/Cassette/MidstreamSpecimen: UrineExpiry date: 24 MonthsFunction: Rapid testStorage: 2-30 centigrade
CE Certificate IVD LH Ovulation rapid test kit LH rapid test cassette specimen urine
Intended Use of Ovulation (LH) Test Cassette
The LH Rapid Test Device (Urine) is a rapid visual immunoassay for the qualitative, presumptive detection of luteinizing hormonein human urine specimens. This kit is intended for use as an aid in the detection of ovulation.
Principle of Ovulation (LH) Test Cassette
The LH Rapid Test Device (Urine) detects human luteinizing hormone through visual interpretation of color development on the strip. Anti-LH antibodies are immobilized on the test region of the membrane, and anti-mouse antibodies immobilized on the control region. During testing, the specimen reacts with anti-LH antibody conjugated to colored particles and precoated onto the sample pad of the strip.The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane.If there is sufficient LH in the specimen,a colored band will form at the test region of the membrane. The presence of this colored band indicates a positive result, while its absence indicates a negative result. The appearance of a colored band at the control region serves as a procedural control, indicatingthat the proper volume of specimen has been added and membrane wicking has occurred.
Catalog and detail information of LH Test Cassette ( Urine)
Product
Name
Production
Information
Catalog No.
Specimen Used
Test Format
Kit Size
LH
H112-11U
Urine
Strip
50 pcs per box
H112-23U
Cassette
25 pcs per box
H112-35U
Midstream
20 pcs/box
H112-36U
Midstream
1pc per bag
Procedure and Result Reading of LH Test Cassette (Urine)
Introduction:
The One Step LH Urine Ovulation Test is fast and easy to use. It is a qualitative test that can predict when there is a
LH (luteinizing hormone) surge, and in turn, when you are likely to ovulate.
When to begin testing:
First, you must determine the length of your menstrual cycle. This is the number of days from the first day of your
menstrual bleeding to the day before your next bleeding begins. Please refer to the chart to determine when you
should start testing. If your cycle is shorter than 21 days or longer than 38 days, consult your doctor. If you do not know
your cycle length, you may begin the test 11 days after your first period since the average cycle length is 28 days.
Perform 1 test each day over a 5 day period, or until the LH surge has been detected.
Urine collection: 1. Do not use first morning urine samples as LH is synthesized in your body early in the morning. It will not show up in
your urine until later in the day.
2. The best time to collect your urine is between 10am and 8pm.
3. Collect urine at about the same time each day.
4. Reduce liquid intake about 2 hours before collecting your urine as a diluted urine sample can prevent the test from
detecting the LH surge.
Interpretation of Results:
Ø No LH Surge: Only one color band appears on the control region, or the test band appears but is lighter than the control band.This means there is no LH surge.
Ø LH Surge: If two color bands are visible, and the test band is equal to or darker than the control band, one will
probably ovulate in the next 24-48 hours. If trying to get pregnant, the best time to have intercourse is after 24 but before 48 hours.
Ø Invalid: No visible band at all. Repeat with a new test kit.
Warnings & Precautions
For in vitro diagnostic use only
1.When uses this product ,you should not take the hCG or the LH medicine which may influence the test result,moreover, In pregnancy, menopause or use of prophylactic drugs during the test ,the result will not normal.
2. As with all diagnostic tests, a definitive diagnostic should not be based on the results of a single test, but should only be made by the physician after all clinical and lab findings have been evaluated.
3.Read directions for use carefully before performing this test. Pay attention to the position of the C and T line .
4. Do not use beyond the labeled expiration date.
5. Do not reuse the test devices. Discard it in the dustbin after single use.
6. Do not use if pouch is damaged or opened.
7. Do not touch the membrane located within the windows.
8. Once open the pouch, the test device should be used immediately. Prolonged exposure to ambient humidity will cause product deterioration.
9.Treat urine samples and used devices as if they are potentially infectious. Avoid contact with skin.
10. Examine if the urine dropper and urine cup exists before usage.
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