Human chorionic gonadotropin (HCG) assay paper (colloidal gold method)

                   Operating instruction

                   (pen)

[product name]

 Common name: human chorionic gonadotropin (HCG) test paper (colloidal gold method)

 English name: One Step HCG Urine Pregnancy The Test (Colloidal Gold) 

 Test paper for early pregnancy (HCG) (colloidal gold immunochromatography)

[packing specifications]

Pen type: Serve 1 person/box.

[intended use]

Human chorionic gonadotropin (HCG) assay paper (colloidal gold method) was used to qualitatively detect human chorionic gonadotropin (HCG) in human urine.

Human chorionic gonadotropin (HCG) is a glycoprotein secreted by the trophoblast cells of the placenta. And & beta; Glycoprotein composition of a dimer. Among them & alpha; -subunit is Shared by the anterior pituitary hormone; & beta; -subunits are specific to HCG. The main function of HCG is to stimulate the corpus luteum, which is conducive to the continuous secretion of estrogen and progestin to promote the formation of the uterine decidua and the growth and maturity of the placenta. HCG proliferates rapidly during the first 8 weeks of pregnancy to maintain the pregnancy. After about 8 weeks of gestation, HCG gradually declines until it reaches relative stability at about 20 weeks. Using HCG double antibody to detect the HCG content in the urine of pregnant women, the result can be quickly obtained in the first trimester of pregnancy, which is an effective method for auxiliary diagnosis.

[main components]

1. Human chorionic gonadotropin (HCG) test paper (colloidal gold method) pen.

2. 1 manual.

3. 1 bag of desiccant.

HCG test paper consists of PVC bottom plate (plastic plate), gold standard pad, reaction film, sample pad and absorbent paper. The gold standard pad is pre-packed with labeled resistance β -hcg monoclonal antibody colloidal gold; The position of the detection line on the reaction membrane was coated with rat resistance &alpha. -hcg monoclonal antibody, control line position coated with sheep anti-mouse IgG polyclonal antibody.

[storage conditions and expiry date]

Original packaging in 4℃ ~ 30℃ dry preservation from light, not frozen storage. The product is valid for 24 months from the date of production. The reagent should be used within 1 hour after the foil bag is torn. The reagents should be used up within 1 month after the seal is opened. 

[sample requirements]

    A disposable clean container is used to collect fresh urine samples at any time. If the urine sample shows visible turbidity, it should be centrifuged, filtered or the upper clear solution should be taken for detection after precipitation. If not, the urine sample can be stored for 72 hours at 2℃-8℃. Long-term storage should be frozen at -20℃, avoid repeated freezing-thawing.

[inspection method]

    Read the instructions before testing and balance the test pen and urine sample to room temperature before using. If opened, use as soon as possible within 1 hour.

   Test pen: take out the test pen before use and unplug the cover. During the test, let the urine drizzle on the urine-absorbing end of the test pen for no less than 5 seconds (please pay attention to the display window during urination). Then put on the cover and continue to hold the test pen or lay it flat.

[interpretation of test results]

  Positive results: both the control line and the detection line showed color, indicating pregnancy

  Negative results: only the control line, indicating no pregnancy

  Invalid result: the control line does not show color, indicating the test failure or reagent failure, it is recommended to retest after dilution. If the problem persists, stop using the product and contact your local supplier or manufacturer.             

 Limitations of testing methods

1. This reagent is used to qualitatively detect HCG in urine samples without determining its concentration.

2. Patients with uterine tumors, hydatidiform mole or menopause may have positive results. If you have multiple test results that do not match your expectations, you must consult your doctor.

3. If the possibility of conception is suspected and the urine test is still negative (possibly due to low HCG levels in the urine or early gestation), a urine sample can be collected again 48-72 hours later.

4. Urine detection of HCG continues for several weeks after the termination of a pregnancy due to natural or unnatural causes (natural birth, caesarean section, habitual abortion or drug abortion).

5. Because other conditions (such as trophoblastic lesions or other non-trophoblastic neoplastic diseases (such as endometrial hyperplasia, breast cancer, and lung cancer) can also contribute to the elevation of HCG, the test results must be determined by the physician in combination with other clinical symptoms and other laboratory indicators. Only after the above conditions are excluded can the company's HCG test paper test results be used to determine whether pregnant. If the results of multiple tests are inconsistent, a doctor must be consulted.

6. Such as ectopic pregnancy, ovarian cyst may produce negative or irregular results. If doubts remain, they can be confirmed with a quantitative reagent. 

7. When a positive test indicates pregnancy, seek medical attention and confirm the diagnosis.

[precautions]

1. This reagent is used only for in - donor testing.

2. Reagents should be sealed and stored to prevent dampness. Reagents and samples kept at low temperature should be balanced to room temperature before use.

3. The test reagent should read the result in 5 minutes, and the result is invalid after 10 minutes.

4. This product is for external diagnosis only. Do not use it as a confirmation reagent.

5. Please use this reagent in the effective period, beyond the effective period, the result may be inaccurate.