Descrizione Clinica
SCREEN
MAMMA TEST
FREE TESTultra-sensitive
Description
The rapid pregnancy test hCG is a rapid lateral flowing immunological test, in midstream format for qualitative detection of human chorionic gonadotropin (hCG) in urine to assist diagnosis of a pregnancy.
The test uses a combination of antibodies including monoclonal hCG to selectively detect high levels of hCG.
The test is performed by pouring the urine on the hydrophilic stick and obtaining the result according to the colored lines.
Precautions
Please read all information before testing.
1. Do not use over the printed expiration date on the sealed packaging.
2. Store in a dry place at 2-30°C or 35,6-86°F. Don't freeze.
3. Do not use if the package is open or damaged.
4. Keep away from the reach of children.
5. Only for in vitro diagnostic use. Not for internal intake.
6. Do not open the sealed package of the test until you are ready to carry out it.
7. The test used should be disposed of according to local regulations.
Mode of use
1. Remove the test from the sealed package and run immediately within an hour.
2. Remove the test cap, then urinate directly on it or immerse it in a urine sample collected in a clean container for at least 15 seconds.
3. Put the cap on the test, then rest everything on a flat and clean surface, immediately start the timer.
4. Wait 3 minutes to read the result; do not wait more than 10 minutes.
Reading results
POSITIVE: two distinct colored lines appear. One should be in the control area (C) and the other in the test zone (T). One line can be lighter than the other; they should not match. This means that you are probably pregnant.
NEGATIVE: A line appears in the control area (C). No line appears in the test line (T). This means that you are probably not pregnant.
NULLO: the result is null if no line appears in the control area (C), although a fleble line appears in the test zone (T). You must repeat the test with a new device.
Limits
There is a possibility that this midstream test produces false results. Consult your doctor before taking any medical decision.
1. Drugs containing hCG (such as Pregnyl, Profasi, Pergonal, APL) can produce a false positive result. Alcohol, oral contraceptives, painkillers, antibiotics or hormonal therapies that do not contain hCG should not affect the test.
2. Very diluted urine samples, as indicated by a specific low gravity, may not contain representative levels of hCG. If you suspect however a pregnancy, you will need to collect a new sample of urine collected first morning 48 hours later and test it.
3. In urine samples immediately after fertilization there are very low levels of hCG (less than 50mlU/ml). However, since a high number of pregnancies end in the first quarter for natural causes, a result of the weakly positive test should be confirmed by testing a new sample of urine collected in the first morning 48 hours later.
4. This test can provide false positive results. A number of conditions other than pregnancy, which include gestational trophoblastic disease and some non-trophoblastic neoplasms, including testicular tumors, prostate cancer, breast and lungs, cause high levels of hCG2,3. Therefore the presence of hCG in urine should not be used to diagnose pregnancy unless such conditions are excluded.
5. This test can produce false negative results. Fake negative results can occur when hCG levels are below the test sensitivity level. If you suspect however a pregnancy, you will need to collect a new sample of urine collected first morning 48 hours later and test it. In case you suspect a pregnancy, but the test continues to produce negative results, consult a doctor for further diagnosis.
6. This test provides a presumed diagnosis of pregnancy. A confirmation diagnosis should be made exclusively by a doctor, after evaluating all clinical and laboratory analyses.
Format
Box containing 2 pieces.
BUDGET
1. Steier JA, P Bergsjo, OL Myking Human chorionic gonadotropin in maternal plasma afterinduced abortion, suspect abortion and removed ectopic pregnancy, Obstet. Gynecol.1984; 64(3): 391-394
2. Dawood MY, BB Saxena, R Landesman Human chorionic gonadotropin and its subunits inhydatidiform mole and choriocarcinoma, Obstet. Gynecol. 1977; 50(2): 172-181
3. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross “Ectopicproduction of human chorionic gonadotropin by neoplasms”, Ann. Intern Med 1973; 78(1): 39-45
The rapid pregnancy test hCG is a rapid lateral flowing immunological test, in midstream format for qualitative detection of human chorionic gonadotropin (hCG) in urine to assist diagnosis of a pregnancy.
The test uses a combination of antibodies including monoclonal hCG to selectively detect high levels of hCG.
The test is performed by pouring the urine on the hydrophilic stick and obtaining the result according to the colored lines.
Precautions
Please read all information before testing.
1. Do not use over the printed expiration date on the sealed packaging.
2. Store in a dry place at 2-30°C or 35,6-86°F. Don't freeze.
3. Do not use if the package is open or damaged.
4. Keep away from the reach of children.
5. Only for in vitro diagnostic use. Not for internal intake.
6. Do not open the sealed package of the test until you are ready to carry out it.
7. The test used should be disposed of according to local regulations.
Mode of use
1. Remove the test from the sealed package and run immediately within an hour.
2. Remove the test cap, then urinate directly on it or immerse it in a urine sample collected in a clean container for at least 15 seconds.
3. Put the cap on the test, then rest everything on a flat and clean surface, immediately start the timer.
4. Wait 3 minutes to read the result; do not wait more than 10 minutes.
Reading results
POSITIVE: two distinct colored lines appear. One should be in the control area (C) and the other in the test zone (T). One line can be lighter than the other; they should not match. This means that you are probably pregnant.
NEGATIVE: A line appears in the control area (C). No line appears in the test line (T). This means that you are probably not pregnant.
NULLO: the result is null if no line appears in the control area (C), although a fleble line appears in the test zone (T). You must repeat the test with a new device.
Limits
There is a possibility that this midstream test produces false results. Consult your doctor before taking any medical decision.
1. Drugs containing hCG (such as Pregnyl, Profasi, Pergonal, APL) can produce a false positive result. Alcohol, oral contraceptives, painkillers, antibiotics or hormonal therapies that do not contain hCG should not affect the test.
2. Very diluted urine samples, as indicated by a specific low gravity, may not contain representative levels of hCG. If you suspect however a pregnancy, you will need to collect a new sample of urine collected first morning 48 hours later and test it.
3. In urine samples immediately after fertilization there are very low levels of hCG (less than 50mlU/ml). However, since a high number of pregnancies end in the first quarter for natural causes, a result of the weakly positive test should be confirmed by testing a new sample of urine collected in the first morning 48 hours later.
4. This test can provide false positive results. A number of conditions other than pregnancy, which include gestational trophoblastic disease and some non-trophoblastic neoplasms, including testicular tumors, prostate cancer, breast and lungs, cause high levels of hCG2,3. Therefore the presence of hCG in urine should not be used to diagnose pregnancy unless such conditions are excluded.
5. This test can produce false negative results. Fake negative results can occur when hCG levels are below the test sensitivity level. If you suspect however a pregnancy, you will need to collect a new sample of urine collected first morning 48 hours later and test it. In case you suspect a pregnancy, but the test continues to produce negative results, consult a doctor for further diagnosis.
6. This test provides a presumed diagnosis of pregnancy. A confirmation diagnosis should be made exclusively by a doctor, after evaluating all clinical and laboratory analyses.
Format
Box containing 2 pieces.
BUDGET
1. Steier JA, P Bergsjo, OL Myking Human chorionic gonadotropin in maternal plasma afterinduced abortion, suspect abortion and removed ectopic pregnancy, Obstet. Gynecol.1984; 64(3): 391-394
2. Dawood MY, BB Saxena, R Landesman Human chorionic gonadotropin and its subunits inhydatidiform mole and choriocarcinoma, Obstet. Gynecol. 1977; 50(2): 172-181
3. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross “Ectopicproduction of human chorionic gonadotropin by neoplasms”, Ann. Intern Med 1973; 78(1): 39-45
