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
English