Instructions for Use of Human Chorionic Gonadotropin (HCG) Test Strips (Colloid gold method)

[Product Name]

Generic name: Human chorionic gonadotropin (HCG) test strips (colloidal gold method)

Trade name: Rapid Test Strip for Early Pregnancy

English name: Human chorionic gonadotropin (HCG) test strip (Colloidal gold method)

[Packing Strength]

Bar product: 1 servings/kit; 2 servings/kit; 10 servings/kit; 100 servings/kit

Plate type/pen type product: 1 servings/kit; 2/kit

[Intended Use]

This test strip is used for qualitative detection of human chorionic gonadotropin content in human urine sample, and is mainly used for the auxiliary diagnosis of ectopic pregnancy and early pregnancy.

[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 HCG antibody as indicator reagent, coating goat anti-mouse polyclonal antibody and HCG antibody on the quality control area and detection area of nitrocellulose membrane, respectively, and adding other auxiliary components. During the test, the sample flows upward through chromatography, and HCG in the positive sample specifically binds to gold-labeled anti-HCG on the gold pad and is captured by HCG monoclonal antibody on the detection line, resulting in the formation of [anti-HCG]-[HCG]-[gold-labeled anti-HCG] 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]

Urine can be tested at any time of day, but usually the morning urine has the highest HCG concentration, so it is best to use the morning urine for testing. It is recommended that urine samples should be tested as soon as possible after collected. If not tested immediately, the urines should be kept at 2-8℃ no longer than 72 hours before testing. For long-term storage, urine may be sub-packed and cryopreserved at - 20℃ for no more than 3 months. Repeated freezing and thawing should be avoided. Urines were detected when they restored to room temperature.

[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 1-5 minutes. Invalid reading after 10 minutes