LH Ovulation Test Strip
PRINCIPLE
One Step LH Ovulation Test is a qualitative, double antibody sandwich immunoassay for the determination of human Luteinizing hormone (hLH) in urine. The membrane was pre-coated with anti-α hLH in the test line region and goat anti-mouse IgG polyclonal antibody in the control line region. During the test process, the patient urine is allowed to react with a colored conjugate (mouse anti-β hLH monoclonal antibody-colloid gold conjugate) which was pre-dried on the test strip. The mixture then moves upward on the membrane chromatographically by a capillary action. This control band serves as a reference of the color intensity of approximately 25mIU/ml LH.
| Product Name | One Step LH Urine Ovulation Test |
| Brand Name | GOLDEN TIME, OEM-Buyer’s logo |
| Dosage Form | In Vitro Diagnostic Medical Device |
| Methodology | Colloidal gold immune chromatographic assay |
| Specimen | Urine |
| Format | Strip |
| material | Paper + PVC |
| Specification | 2.5mm 3.0mm 3.5mm 4.0mm 4.5mm 5.0mm 5.5mm 6.0mm |
| Sensitivity | 25mIU/ml or 10mIU/ml |
| Accuracy | >=99.99% |
| Specificity | No across reactivity with 500mIU/ml of hLH, 1000mIU/ml of hFSH and 1mIU/ml of hTSH |
| Reaction Time | 1-5 minutes |
| Reading Time | 3-5 minutes |
| Packaging | 1/2/5/25/50/100pcs/box |
| range of application | All levels of medical units and home self-test. |
| Certification | CE, ISO, NMPA, FSC |
REAGENTS
One LH Ovulation test strip per foil pouch.
Ingredients: Test device comprised of colloidal gold coated with 1.5mg/ml goat antibody
mouse 1mg/ml mouse anti α LH antibody and 4mg/ml mouse anti β LH antibody.
MATERIALS PROVIDED
Each pouch contains:
1.One One Step LH Ovulation Test strip
2.Desiccant
Each box contains:
1.One One Step LH Ovulation Test foil pouch
2.Urine cup
3.Package insert
No other equipment or reagents are needed.
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.
DETERMINATION OF TEST DATE
As we know, a peak of LH concentration will come before ovulation .The ovulation of ovaries has a close relationship with the peak of LH release in menstrual period. LH peak predicts ovulates in the coming 24-48 hours. Therefore, testing appearance of LH peak in the menstrual period could ensure the best time of fertilization .
So to determine when to start testing ,you must know firstly the length of your menstrual cycle .
Note: if you are unsure your cycle length,you may begin doing this test for 11 days after your first period ，one for each day and stop it until the LH surge has been detecte
TEST PROCEDURE
1) Remove the test strip from the foil pouch
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. You may take the strip out after a minimum of 15 seconds in the urine and lay the strip flatly on a non-absorptive clean surface. (See picture below)
3).Read the result at 10 minutes .
DO NOT INTERPRET RESULT AFTER 10 MINUTES.
4) Discard the test device after single use in a dustbin.
Negative：Only one pink line appears in the control region (C).or both of the lines in the control region and the test region appear, but the test line (T) present is lighter than that of the control line (C) in color intensity .This indicates that no LH surge has been detected and you should continue daily testing .
Positive : Two distinct pink lines appear, one is in the test region (T), and the other in the control region (C), the test line (T) is equal or darker than the control line (C)in color intensity .Then you will probably ovulate in the next 24-48 hours. And if you want to be pregnant ,the best time to have intercourse is after 24hours but before 48 hours.
Invalid: If there is no pink-purple colored lines visible both in the test region(T) and control region(C), or there is pink-purple colored line in the test region(T), but no line in control region(C), the test is invalid. It is recommended that the test should be repeated in this case.
