Instructions for Use of Luteinizing Hormone (LH) Test Strips (Colloidal Gold Method)

[Product Name]

Generic name: Luteinizing Hormone (LH) Test Strip (Colloidal Gold Method)

Trade name: Ovulation Test Strip

English name: Luteinizing hormone (LH) test strip (Colloidal gold method)

[Packing Strength]

Bar product: 1 servings/pack; 5 servings/pack; 6 servings/pack; 10 servings/pack; 100 servings/pack

Plate type/pen type product: 1 servings/pack; 2 servings/pack; 5 servings/pack; 6 servings/pack

[Intended Use]

This product is used for qualitative detection of luteinizing hormone level in human urine.

[Test Principle]

This product is developed based on the reaction principle of double antibody sandwich method in combination with colloidal gold immunochromatography technology. The product is prepared by using colloidal gold-labeled LH antibody as indicator reagent, coating goat anti-mouse polyclonal antibody and LH antibody on the quality control area and detection area of nitrocellulose membrane, respectively, and adding other auxiliary components. During the detection, the sample flows upward through chromatography, and HL in the positive sample specifically binds to gold-labeled anti-LH on the gold pad and is captured by HCG monoclonal antibody on the detection line, resulting in the formation of [anti-LH]-[LH]-[gold-labeled anti-LH] complex, thus showing a red band on the detection line (T). In the case of a negative sample, no test line (T) will appear.

[Main components]

1. Strip test paper: test strip, urine cup (optional)

2. Plate test paper: Plate test paper, pipette and urine cup (optional)

3. Pen test paper: Pen test paper, urine cup (optional)

[Storage Conditions and Shelf Life]

Store in a dark and dry place at 4℃~30℃ and shelf life is 36 months.

[Sample Requirements]

1. Fresh urine samples should be used for timely detection as far as possible;

2. Please conduct the test at a relatively fixed time every day. Do not drink a lot of water before the test;

3. First determine the number of days (A) of the usual menstrual cycle, that is, the number of days from the first day of each menstruation to the first day of the next menstruation; The date (P) of the first day of this menstruation. The first test date is equal to P + (A-17), for 5 consecutive days; If the menstrual cycle is irregular, take the shortest of the last three months, and it is recommended to continuously test for 10 days;

4. If the collected urine sample cannot be tested in time, the sample can be stored at 2 ~ 8 ℃ for 72 hours; After long-term storage, it can be dispensed and cryopreservedat -20 ℃ for no more than 3 months. Repeated freezing and thawing should be avoided, and it should be equilibrated to room temperature before testing.

[Test Methods]

1. Tear open the foil pouch and remove the test paper.

2. Operate according to the product model.

Strip-type/plate-type products: Collect the urine in a clean and dry urine cup, hold the handpiece of test paper, immerse the end marked by Max line or arrow into the urine, pay attention not to make the urine exceed the horizontal line indicated by arrow, keep it for 10 ~ 20S, then take it out and lay it flat; if it is equipped with a straw, suck a small amount of urine from the urine cup, and slowly drop 2 ~ 5 drips of urine into the round hole of test plate.

Pen-type product: Take off the pen cap to expose the sample adding area, directly drench the sample adding area with urine, keep for 5 ~ 10 seconds, and then place the window of the test pen flat up.

3. Observe the results for 5 ~ 10 minutes. The result read after 15 minutes is invalid.

[Reference range]

The test result is positive when the concentration of luteinizing hormone (LH) in human urine sample is not less than 25mIU/mL.

[Interpretation of Test Results]

1. Positive: The reaction line T is as dark as the control line C and predicts ovulation within 48 hours.

The reaction line T is darker than the control line C and predicts spontaneous ovulation within 14-28 hours.

2. Negative: The reaction line T is lighter than the control line C or only one control line C appears, indicating that the LH peak has not occurred or the peak has passed.

3. Ineffective: No control line C appears within 5 ~ 10 minutes, please retest or contact the supplier.