GIMA Ultra HCG Pregnancy Rapid Test Midstream URINE User Manual

GIMA Ultra HCG Pregnancy Rapid Test Midstream URINE User Manual

TEST RAPIDO DI GRAVIDANZA ULTRA MIDSTREAM HCG (URINA) ULTRA HCG PREGNANCY RAPID TEST MIDSTREAM (URINE) TEST RAPIDE DE GROSSESSE ULTRA MIDSTREAM HCG (URINE) PRUEBA DE EMBARAZO RÁPIDA ULTRA MIDSTREAM HCG (ORINA) TESTE RÁPIDO DE GRAVIDEZ ULTRA MIDSTREAM HCG (URINA) ULTRA MIDSTREAM HCG () ULTRA HCG SCHWANGERSCHAFTSSCHNELLTEST – MIDSTREAM SZYBKI TEST CIOWY ULTRA HCG TYPU MIDSTREAM (MOCZ)

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PRINCIPLE

Ultra HCG Pregnancy Rapid Test Midstream is a rapid, one-step lateral flow immunoassay in midstream format for the qualitative detection of human chorionic gonadotropin (chg.) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated level of hCG. The assay is conducted by adding urine to the hydrophile stick and obtaining the result from the coloured lines.

PRECAUTIONS

Please read all the information in this package insert before preforming the test.
– Do not use after the expiration date printed on the foil pouch.
– Store in a dry place at 2-30°C or 35.6-86°F. Do not freeze.
– Do not use if pouch is torn or damaged.
– Keep out of the reach of children.
– For in vitro diagnostic use. Not to be taken internally.
– Do not open the test foil pouch until you are ready to start the test.
– The used test should be discarded according to local regulations.

KIT CONTENT:

– Test midstream
– Package insert

MATERIALS REQUIRED BUT NOT PROVIDED

– Timer – Specimen Collection Container

INSTRUCTIONS

1. Remove the midstream from the foil pouch and test it immediately in one hour
2. Take down the cap of the midstream, hold the midstream so as to place the absorbent tip in the urine stream or place the absorbent tip (2/3) in urine in a clean cup for at least 15 seconds.
3. Cover the cap on the testing midstream, then lay down the product on a clean and stable desk, start the timer immediately.
4. Read the result at 3 minutes; don’t interpret the result after 10 minutes.

READING THE RESULTS

POSITIVE: Two distinct coloured lines appear. One line should be in the Control Window (C) and another line should be in the Test Window (T). One line may be lighter then the other; they do not have to match. This means you are probably pregnant.
NEGATIVE: One coloured line appears into the Control Window (C). No line appears in the Test Window (T), This means that you are probably not pregnant.
INVALID: The result is invalid if no coloured line appears in the Control Window (C), even if a line appears in the Test Window (T). You should repeat the test with a new midstream test.

LIMITATIONS

There is the possibility that this test midstream may produce false results. Consult your physician before making any medical decisions.

1. Drugs which contain hCG (such as Phenyl, Prophase, Personal, APL) can give a false positive result. Alcohol, oral contraceptives, painkillers, antibiotics or hormone therapies that do not contain hCG should not affect the test result.
2. Very dilute urine specimens, as indicated by a low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested.
3. Very low levels of hCG (less than 50mIU/ml) are present in urine specimens shortly after implantation. However, because a significant number of first trimester pregnancies terminate for natural reasons1,a test result that is weakly positive should be confirmed by retesting with a first morning urine specimen collected 48 hours later.
4. This test may produce false positive results. A number of conditions other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasms including breast cancer, and lung cancer, cause elevated levels of hCG2,3. Therefore, the presence of hCG in urine should not be used to diagnose pregnancy unless these conditions have been ruled out.
5. This test may produce false negative results. False negative results may occur when the levels of hCG are below the sensitivity level of the test. When pregnancy is still suspected, a first morning urine specimen should be collected 48 hours later and tested. In case pregnancy is suspected and the test continues to produce negative results, see a physician for further diagnosis.
6. This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.

QUESTIONS & ANSWERS

1. How does the test work?
   The Test detects a hormone in your urine that your body produces during pregnancy (hCG – human chorionic gonadotropin). The amount of pregnancy hormone increases as pregnancy progresses.

2. How soon after I suspect that I am pregnant can I take the test?
   You can test your urine as early as the first day you miss your period. You can perform the test anytime of the day; however, if you are pregnant, first morning urine contains the most pregnancy hormone.

3. Do I have to test with first morning urine?
   Although you can test at any time of the day, your first morning urine is usually the most concentrated of the day and would have the most hCG in it.

4. How accurate is the test?
   A clinical evaluation was conducted comparing the results obtained using the Test to another commercially available urine hCG test. The consumer clinical trial included 608 urine specimens: both assays identified 231 positive and 377 negative results. The results demonstrated > 99.0% overall accuracy of the Test when compared to the other urine hCG test.

5. How sensitive is the test?
   The test detects hCG in urine at a concentration of 10 mIU/mL or greater. The test has been standardized to the W.H.O. Third International Standard. The addition of LH (300 mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative (0 mIU/mLm hCG) and positive (10 mIU/mL hCG ) specimens showed no cross-reactivity.

6. What should I do if the result shows that I am pregnant?
   It means that your urine contains hCG and you are probably pregnant. See your doctor to confirm that you are pregnant and to discuss the steps you should take.

7. How do I know that the test was run properly?
   The appearance of a collared line in the control window (C) tells you that you followed the test procedure properly and the proper amount of urine was absorbed.

8. What should I do if the result shows that I am pregnant?
   It means that no hCG has been detected in your urine and probably you are not pregnant. If you do not start your period within a week of its due date, repeat the test with a new midstream test. If you receive the same result after repeating the test and you still do not get your period, you should see your doctor.

BIBLIOGRAPHY

1. Steier JA, P Bergson, OL Making Human chorionic gonadotropin in maternal plasma after induced abortion, spontaneous abortion and removed ectopic pregnancy, Obstet. Gynecol.1984; 64(3): 391-394;
2. Dawood MY, BB Saxena, R Landsman Human chorionic gonadotropin and its subunits in hydatidiform mole and choriocarcinoma, Obstet. Gynecol. 1977; 50(2): 172-181;
3. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross “Ectopic production of human chorionic gonadotropin by neoplasms”, Ann. Intern Med. 1973; 78(1): 39-45

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