SCREEN
MAMMA TEST
PREGNANCY TEST
ultra-sensitive Description
The hCG rapid pregnancy test is a rapid lateral-flow immunoassay in midstream format for the qualitative detection of human chorionic gonadotropin (hCG) in urine, to aid in the diagnosis of pregnancy.
The test uses a combination of antibodies, including monoclonal hCG, to selectively detect elevated levels of hCG.
The test is performed by applying urine to the absorbent stick and obtaining the result from the coloured lines.
Precautions
Please read all the information before performing the test.
1. Do not use after the expiry date printed on the sealed pouch.
2. Store in a dry place at 2-30°C or 35.6-86°F. Do not freeze.
3. Do not use if the pouch is open or damaged.
4. Keep out of the reach of children.
5. For in vitro diagnostic use only. Not for internal use.
6. Do not open the sealed test pouch until you are ready to perform the test.
7. The used test should be disposed of in accordance with local regulations.
Directions for use
1. Remove the test from the sealed pouch and use it immediately, within one hour.
2. Remove the cap from the test, then urinate directly on it or dip it into a urine sample collected in a clean container for at least 15 seconds.
3. Replace the cap on the test, then lay it on a clean, flat surface and start timing immediately.
4. Wait 3 minutes to read the result; do not wait more than 10 minutes.
Reading the results
POSITIVE: two distinct coloured lines appear. One should be in the control zone (C) and the other in the test zone (T). One line may be fainter than the other; they do not have to match. This means you are probably pregnant.
NEGATIVE: one line appears in the control zone (C). No line appears in the test zone (T). This means you are probably not pregnant.
INVALID: the result is invalid if no line appears in the control zone (C), even if a faint line appears in the test zone (T). Repeat the test with a new device.
Limitations
This midstream test may produce false results. Consult your doctor before making any medical decision.
1. Medicines containing hCG (such as Pregnyl, Profasi, Pergonal, APL) may give a false positive result. Alcohol, oral contraceptives, painkillers, antibiotics or hormone therapies that do not contain hCG should not affect the test.
2. Very dilute urine samples, as indicated by a low specific gravity, may not contain representative levels of hCG. If pregnancy is still suspected, a new first-morning urine sample should be collected 48 hours later and tested.
3. Very low levels of hCG (below 50 mIU/ml) are present in urine samples shortly after conception. However, since a significant number of pregnancies end in the first trimester for natural reasons, a weakly positive test result should be confirmed by testing a new first-morning urine sample collected 48 hours later.
4. This test may give false positive results. A number of conditions other than pregnancy, including gestational trophoblastic disease and certain non-trophoblastic neoplasms, including testicular tumours, prostate, breast 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 give false negative results. False negative results may occur when hCG levels are below the sensitivity level of the test. If pregnancy is still suspected, a new first-morning urine sample should be collected 48 hours later and tested. If pregnancy is suspected but the test continues to give negative results, consult a doctor for further diagnosis.
6. This test provides a presumptive diagnosis of pregnancy. A confirmed diagnosis should only be made by a doctor after all clinical and laboratory findings have been evaluated.
Format
Box containing 1 piece.
BIBLIOGRAPHY
1. Steier JA, P Bergsjo, OL Myking Human chorionic gonadotropin in maternal plasma afterinduced abortion, spontaneous 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
